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Job Description Job description Granulation Technology, Inc. is a leading pharmaceutical manufacturer specializing in high-quality OTC (over-the-counter) products. As a fast-growing, Indian-owned and majority women-owned company, we are committed to excellence, innovation, and customer satisfaction. Role Overview: We are seeking a results-driven Pharmaceutical OTC Sales Representative to expand our market presence, secure new accounts, and maintain strong relationships with key customers. This is an exciting opportunity for a sales professional with experience in the pharmaceutical OTC industry. Responsibilities: ✅ Identify and develop new sales opportunities within the OTC pharmaceutical market. ✅ Build and maintain relationships with distributors, retailers, and healthcare providers. ✅ Present and promote our OTC products to potential clients. ✅ Negotiate contracts, pricing, and supply agreements. ✅ Stay updated on industry trends, competitor activity, and market demands. ✅ Collaborate with internal teams (marketing, regulatory, and logistics) to ensure customer satisfaction. ✅ Meet or exceed sales targets and KPIs. Qualifications: Experience: 10+ years in OTC pharmaceutical sales. Skills: Strong negotiation, relationship-building, and communication skills. Knowledge: Familiarity with the OTC market, retail distribution, and pharmacy channels. Self-Motivated: Ability to work independently and drive results. Travel: Willingness to travel as needed for client meetings and industry events. Why Join Us? ✨ Opportunity to work with a growing pharmaceutical company. ✨ Competitive salary with uncapped commission potential. ✨ Flexible work environment with career growth opportunities. ✨ Be part of a dynamic, diverse, and innovative team. Company DescriptionGranulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.Granulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.

Job Description The Press Operator is responsible for the safe and efficient operation of a press while adhering to customer specification, quality requirements, company standards, and guideline and safety standards. This position is responsible for the overall completion of the job assigned to the Press Operator 1st 6:05am - 04:25pm and 2nd shift 4:20pm - 2:40am Monday - Thursday. Mandatory over-time on Fridays. • Inspections of printed material to ensure the correctness in all areas of color, registration, stock, and all other customer specifications., • Adjusting and maintaining registration, color, perforations, and other customer specific printing specifications., • Observes the press operations to detect any machine or equipment malfunctions and moves to correct the issues., • Makes adjustments to all press machine parts and equipment: feeders, grippers, guides, feed wheels, cameras, and other machines parts, using proper equipment., • Conducts a visual inspection prior to printing of all material stock and ink for defects or noncompliance to job specifications., • Carries out the final inspection to ensure the material, ink, plates or screens, cylinder/rollers, tension, and all other necessary customer specifications are correct prior to the start of the running the job., • Review and interpret job specifications and work order instructions, delegates or carries out directions as needed., • Ensures all job-related data (time and material) are entered into the ERP system (DISO)., • Ensures all unused material goes back to the designated area after each job is finished running., • Knowledge of cGMP, ISO and Lean Manufacturing is a plus. Reading, analyzing, and interpreting technical procedures, manuals and manufacturing documents including the system of Graphic specification/Graphic identical/Articles., • Experience with inks and material., • High School Diploma or General Equivalent Degree (GED), • Experience with handling and proper caring of die cutting tools., • Experience with machine set-up, • Experience with UV and water-based inks preferred., • Experience working with vision systems preferred., • Working knowledge of quality procedures in the pharmaceutical industry preferred., • Ability to lift 50 pounds., • Standing for long periods of time.

A leading pharmaceutical company in Rahway, NJ is seeking an Executive Director for Financial Planning & Analysis.This role will support the Manufacturing and Research & Development divisions, leading a team in providing strategic financial analysis and forecasting.The ideal candidate will have 15+

Job DescriptionBenefits: • Free Parking, • Short-Term and Long-Term Disability, • Flexible Spending, • Life and Accidental Death and Dismemberment, • 401(k), • 401(k) matching, • Competitive salary, • Dental insurance, • Health insurance, • Paid time off What is Natco Pharma USA? Based in Northern New Jersey, we are a fast-growing, innovative specialty pharmaceutical company, distributing solutions for both retail and institutional needs from leading global manufacturers. Were revolutionizing the U.S. pharmaceutical industry by making high-quality medicines more accessible and affordable. As a subsidiary of Natco Pharma Ltd., a global leader with a presence in over 50 countries, we are proud to bring top-tier pharmaceutical products to the American marketplace. Who are we looking for? We are seeking an experienced and hands-on Associate Director, Quality to lead and oversee the U.S. Quality function. This is a high-visibility role responsible for leading U.S. Quality and compliance activities, supporting external manufacturing partners, and upholding the highest standards of CGMP and product quality. In this lean, entrepreneurial environment, the Associate Director will serve as the primary Quality authority for U.S. operations, overseeing regulatory interactions, audit readiness, and product release activities. In this role, you will • Support and coordinate Natco Pharma Limited and Natco Pharma USA ("NATCO") regulatory and pharmacovigilance initiatives., • Support qualification of Natco CMO and 3PL vendors. Perform scheduled CGMP audits of CMOs and 3PL vendors., • Supervise site audits of Natco by FDA, NJ regulatory agencies,. and customers. Prepare and submit CAPA responses to FDA until final approval and closure., • Monitor direct contacts with 3PL's including contract laboratories, LSL, SafetyCall. Maintain company and customer documents., • Approve and release Natco Pharma Limited and Natco Pharma USA, as applicable, CMO Master Batch Records, packaging and shipping authorizations, Change Controls, Deviations, OOS Investigations, Stability Program, COAs, COCs for finished product release for distribution., • Work with Safety call to document all product inquiries, complaints, and adverse events., • Review labeling., • Prepare, review and revise SOPs, • Personnel Training, • 10-15% travel timeYou must have, • B.S. in a science discipline, • Minimum of 10 years experience in the quality/compliance finished dosage form drug product area, • Good communication skills Disclaimer Natco Pharma USA is a proud Equal Employment Opportunity employer and encourages applicants from all walks of life. All employment decisions are based on business needs, job requirements and individual qualifications without regard to race, religion, creed, color, sex, pregnancy, childbirth or related medical conditions, national origin, age, ancestry, veteran status, liability for military service or military status, disability, mental illness, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), unemployment status (with respect to job advertisements), affectional or sexual orientation, gender identity or expression, marital, domestic partnership, or civil union status, lawful activity outside the workplace during non-work hours, such as the use of tobacco products, or any other characteristics protected by law. Come join our team!

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix is looking for a full-time Senior Director of Program and Portfolio Management (PPM) to effectively shape and implement PPM strategies decision making for a complex portfolio of drug development programs and execution of decisions. The Senior Director of PPM will be a responsible for implementing portfolio management best practices, drafting strategic and operational plans, mentoring project managers (PM) and operational staff, and supporting effective communications across multiple departments at Tonix. The individual in this position will also be responsible for building out the team of PMs which would report into this role. This is a fast-paced, challenging position offering a competitive compensation and benefits package. This position will report directly to the Company’s Chief Operating Officer that will ideally be based at the Tonix Chatham, NJ office. Essential Duties • Lead and manage cross-functional teams interacting with clinical, nonclinical, regulatory, CMC, discovery, and others to set priorities, work toward goals and monitor progress of programs, • Develop portfolio tools and materials to support portfolio decision-making, • Create, implement, and refine PPM practices to support leadership, PPM staff, and delivery of program goals, • Lead regular portfolio operations committee meetings and portfolio strategy sessions, • Coordinate and manage due diligence teams and decision making on in licensing activities for the portfolio, • Help to buildout and lead PMs responsible for developing cross-functional program plans, timelines, and budgets in collaboration with functional area leads, • Facilitate effective, science-based business decisions including development of scenarios and strategic impact of decisions, • Ensure all decisions are assessed as to their risks and impacts as well as accountable for communication to team and stakeholders in a transparent and timely manner, • Function as an integrator within the project team and across the Company to ensure alignment, • Develop and coordinate resource and budget planning activities across functions to ensure adequate resources are applied to the programs and decisions are assessed for portfolio impact, • Provide leadership to teams and functional areas to proactively anticipate and identify project issues which pose a challenge to achieving strategic goals; propose and implement plans to resolve such issues, and execute corrective actions, • Effectively execute change management to implement strategies for effecting, controlling, and helping teams adapt to change, • Provide updated project information for the Board as well as for regular budget and portfolio reviews, • Enable high-performing teams by ensuring good team dynamics within the project team, • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s), • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork, • Recruits, interviews, hires, and trains new team members, • Oversees the daily workflow of the department, • Provides constructive and timely performance evaluations, • If necessary, handles discipline and termination of employees in accordance with company policy, • Bachelor’s degree and fifteen (15) years of relevant project / program / portfolio management experience within the pharmaceutical / biotechnology industry; or a PhD in a scientific field or a PharmD, DVM or MD degree with ten (10) years of relevant experience preferred, • Scientific background and/or MBA preferred, • Ten (10) years of leading cross-functional program or portfolio management activities within the pharmaceutical industry with a deep understanding of practices and standards of pharmaceutical program and portfolio management preferred, • Experience managing PM professionals in the drug development industry, • Strong leadership presence with the ability to translate strategy into action, • Excellent analytical skills with an ability to summarize and present complex information in a clear and concise manner to support decision-making, • Ability to create an inclusive environment and lead empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration, • Outstanding verbal and written communications skills with the ability to effectively interact with and influence all levels within the company, • Ability for minimal travel, • Dedicated team player who is able to withstand the high demands of a fast-paced environment Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $200,000 to $300,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

Job Description This is a fantastic opportunity to join Luminance, the pioneer of Legal-Grade™ AI for enterprise. Backed by internationally renowned VCs and named in both the Forbes AI 50 list of ‘Most Promising Private AI Companies in the World’ and Inc. 5000’s ‘Fastest Growing Companies in America’, Luminance is disrupting the legal profession around the globe. Luminance is looking to hire into its team of Product Specialists: this team provide expertise to prospective customers and customers alike, ensuring they experience a seamless execution of Luminance’s technology within their own environment. Are you curious, confident, and eager to launch your career in technology? Join us as a Product Specialist, where you’ll play a key role in helping businesses across the world understand and adopt cutting-edge AI technology. In this entry-level role, you’ll work closely with senior teams at an exciting range of organizations — from multinational law firms and manufacturing companies to global retailers and pharmaceutical giants. You’ll be at the forefront of customer engagement, learning how to translate complex technology into real-world value. As a Product Specialist, you’ll play a key role in supporting the Sales team to win new business. Working closely with prospective clients, you’ll use your in-depth understanding of our technology to demonstrate how it delivers value — particularly within the legal sector. During the Pre-Sales Proof of Value (trial) period, you’ll guide potential customers through their projects and use cases, providing expert insight and ensuring they see the real impact of our AI technology. While your primary focus will be on supporting new logo acquisition, you’ll also collaborate with our Customer Success Team and Support teams to help existing customers maximize their experience and return on investment with our platform. Responsibilities • Work with Account Executives to deliver successful Proof of Values and manage live projects from planning stages to final review, • Act as an expert of Luminance’s products, supporting the sales team in converting these prospects, • Understand the individual use cases, review requirements and needs of each prospect during the Proof of Value, • Be a trusted adviser and authority on the product to the prospect during the Proof of Value, • Bachelor’s or Master’s Degree in a STEM discipline, with GPA of 3.5 or above with an interest in legal are encouraged to apply, • Highly-detail oriented with a problem-solving attitude, • Strong technical acumen and the ability to understand, translate and simplify concepts to both technical and non-technical audiences, • Excellent communication skills for translating between customer needs and internal teams, including Product and Engineering, • Organized with excellent time management skills with an ability to prioritize effectively, • Prior experience at a high-growth startup — especially in Solutions or Sales Engineering — is a plus, • Compensation - $75,000 annually, • Comprehensive healthcare, including vision, dental, • Flexible Spending Account (FSA), • Hybrid working environment, • 401k, • $2,750 dedicated to learning and development budget, • Company holiday party

Job Description Join EAD to help solve complex structural challenges in industrial facilities. EAD supports projects across industrial manufacturing facilities, including food processing, pharmaceutical manufacturing, and parcel handling environments. This role offers the opportunity to work on projects of varying size and complexity in a fast-paced, multi-discipline, and practical engineering setting. EAD is looking for a Staff Structural Engineer. The Staff Structural Engineer supports industrial and manufacturing projects by delivering safe, accurate, and buildable structural engineering solutions for new and existing facilities. This role is best suited for a structural engineering generalist who can work across a wide range of industrial building and support systems, coordinate well with other disciplines, and thrive in brownfield environments where field conditions matter. What Success Looks Like In this role, success means: • Delivering structural work on scope, on time, and on budget, • Producing code-compliant, practical, and constructable solutions, • Working effectively across disciplines and with field realities, • Building versatility across industrial structural applications, • Perform structural analysis, calculations, and design for industrial facilities and support systems, • Develop practical solutions for structural modifications in existing brownfield environments, • Use sound judgment in existing facilities where field conditions, undocumented changes, and constructability constraints require thoughtful evaluation and practical solutions., • Support design of a broad range of structural elements such as wall, floor, and roof systems, platforms, mezzanines, equipment supports, foundations, and related industrial structures, • Conduct field investigations, verify existing conditions, and apply findings to design, • Coordinate with mechanical, process, electrical, architectural (when required), civil (when required), and other project team members, • Prepare clear engineering deliverables, including calculations, sketches, markups, specifications, and support for drawing development, • Participate in design reviews, quality checks, and constructability discussions, • Communicate proactively with project teams, clients, contractors, and vendors, • Support construction and installation questions as needed, • Bachelor's degree in Structural or Civil Engineering from an accredited institution, • Licensed Professional Engineer (PE), • Experience with structural analysis and applicable building codes, • Experience with OSHA requirements, • Experience working with multi-discipline project teams, • Experience with producing clear and concise engineering drawings and sketches, • Experience with simple architectural furnishes (IMP, Roof and Wall Penetrations, Floor Coatings), • Ability to produce clear, organized, and dependable engineering work, • Working knowledge of design tools such as AutoCAD, Revit, and structural analysis software, • Strong written and verbal communication, • Ability to perform field work and maintain a valid driver's license, • Experience in food, beverage, life sciences, or pharmaceutical environments, • Experience supporting cGMP areas or equipment support structures, • Acts with integrity, sound judgment, and professionalism, • Owns commitments, follows through, and closes loops, • Communicates early and clearly when risks, questions, or changes arise, • Works in a way that helps the broader project team succeed, • Brings a practical, solution-oriented mindset to complex facility problems, • Office, plant, or client site environment*, • Ability to sit and work at computer for extended periods of time, • Ability to walk up numerous flights of stairs/ladders multiple times a day and/or work in tight spaces in extreme conditions, • May work near moving mechanical parts and equipment*, • Office, Commercial and/or Industrial setting with the potential of exposure to fumes or airborne particles, toxic or caustic chemicals*, • Ability to lift and/or move up to 50 lbs.*, • Periodic weekend, holiday or evening work as needed We strongly believe that diversity of experience, perspectives, and background will lead to a better workplace for our employees and a better product for our customers and members. EAD is an Equal Opportunity Employer Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.

Job Description Job Responsibilities: • Collaborate with cross-functional teams, including commercial, medical, legal, and other expertise areas, for review and approval of promotional materials and materials used in scientific exchange for assigned products., • Work closely with Regulatory Operations in making timely 2253 submissions to OPDP., • Work closely with regulatory strategy development colleagues regarding proposed product labeling changes to assess and determine the impact on promotional materials., • Effective project management skills to oversee the development, review, and approval of promotional materials, ensuring timely submissions and compliance, • Demonstrated ability to manage multiple assignments, appropriately identify regulatory issues, and communicate as needed to management, • Detail-oriented with the ability to promptly assess materials for accuracy as well as consistency Bachelor 's degree in a life science with a minimum of 4 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; Job Type & Location This is a Contract position based out of Parsippany, NJ. Pay and Benefits The pay range for this position is $50.00 - $52.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Parsippany,NJ. Application Deadline This position is anticipated to close on Apr 1, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Job Description Job Opportunity: Construction Superintendent (Ground-Up Projects) Mid-Senior Level | Full-Time | NYC License Required We’re seeking a seasoned Construction Superintendent to oversee large-scale, ground-up construction projects. This is a hands-on site leadership role for an expert in lump sum contracting with a commitment to quality, safety, and deadlines. Key Responsibilities: • Lead on-site construction activities from start to finish, • Supervise trades and vendors for quality, schedule, and safety, • Coordinate material deliveries and approvals, • Manage site reports, time sheets, compliance forms, and logs, • Conduct inspections and coordinate with banks and project teams, • Enforce safety protocols and site security, • 10+ years’ construction experience; 5+ years in supervision, • Strong leadership, communication, and organizational skills, • Proficient in blueprint reading, project documentation, and Microsoft Office, • Procore experience preferred, • Bachelor's degree preferred (or equivalent experience), • Must hold an active NYC Construction Superintendent LicenseCompany DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. Leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Manage CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field or equivalent experience., • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience., • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA, • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications, • Must be able to analyze data/information and to assess and resolve complex problems, • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing, • Knowledge of operational processes and controls in non-sterile and sterile operations, • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description This is a fantastic opportunity to join Luminance, the pioneer of Legal-Grade™ AI for enterprise. Backed by internationally renowned VCs and named in both the Forbes AI 50 list of ‘Most Promising Private AI Companies in the World’ and Inc. 5000’s ‘Fastest Growing Companies in America’, Luminance is disrupting the legal profession around the globe. Off the back of a $75 million Series C funding round, this is a unique opportunity to help spearhead Luminance’s sales team, leading a team of Account Executives and working with businesses spanning every sector, from major manufacturing companies and high growth technology companies to global retailers and pharmaceutical giants. As a Commercial Director you will lead, manage, and motivate an enterprise sales team to achieve key metrics and deliver exceptional results. You will also oversee the end-to-end sales process, including prospecting, lead generation, qualification, proof-of-value (POV) design/deployment, proposal development, negotiation, and closing deals. In addition, you will be key in developing and executing comprehensive sales strategies that align with Luminance's global business objectives. Responsibilities • Leadership - Provide coaching, guidance, and professional development opportunities to individual AEs; assist in recruiting, staffing, and onboarding activities to grow and maintain a high-performing team., • Sales Planning - Identify market opportunities, competitive landscape, and customer needs to drive sales growth., • Process Management - Collaborate with internal teams to ensure seamless execution and delivery of Luminance's technology; identify gaps and propose ongoing process improvements to enhance efficiency., • 2+ years of recent experience leading enterprise or commercial/mid-market sales reps in a fast-paced environment., • 5+ years of full-cycle, B2B sales experience; a successful track record of winning new business at the enterprise and strategic level., • Demonstrated success in forecasting, territory account mapping, research and planning and running discovery meetings for key/strategic accounts., • Excellent communication skills; the ideal candidate will be a natural, confident and articulate storyteller with the ability to articulate complex ideas and engage varied audiences with ease., • Ability to work autonomously while also collaborating with multi-disciplined teams. Very competitive OTE (total package open to consideration, subject to experience)

Job Description 2nd shift: 3pm-11pm Temp to Perm A 2nd shift Maintenance Technician ensures the continuous operation of highly specialized equipment and cleanroom facilities during evening hours. They are responsible for troubleshooting, repairing, and performing preventative maintenance (PM) on complex machinery, such as autoclaves, bioreactors, and automated packaging systems, while strictly adhering to Good Manufacturing Practices (cGMP) and OSHA safety standards. Key Responsibilities • Preventive & Corrective Maintenance: Perform scheduled PMs, diagnose mechanical/electrical failures, and repair equipment to minimize downtime, often working independently with minimal supervision., • Equipment Specialization: Maintain lab-specific equipment, including CO2 incubators, bioreactors, cryogenics, clean steam generators, and water purification systems (RO/DI)., • GMP & Documentation: Accurately document all maintenance activities, repairs, and inspections in a Computerized Maintenance Management System (CMMS) according to Good Documentation Practices (GDP)., • Safety & Compliance: Maintain a clean, 5S-compliant work area, wear appropriate Personal Protective Equipment (PPE) such as PAPR, and comply with safety regulations (OSHA, EPA, FDA)., • Technical Expertise: Strong knowledge of electro-mechanical, pneumatic, and hydraulic systems, with experience in troubleshooting PLC-controlled equipment., • Education/Experience: High School diploma or GED required, with a technical school certificate or equivalent experience (often 3-5+ years) in a manufacturing or pharmaceutical environment., • Regulatory Knowledge: Familiarity with cGMP, FDA, and OSHA requirements., • Physical Ability: Ability to lift up to 50 lbs, work in confined spaces, and stand for extended periods., • Autonomy: Higher need for independent problem-solving due to reduced management presence., • Support: Often responsible for covering both production machinery and facility-wide utilities. Company DescriptionFortune 100 Homebuilding companyFortune 100 Homebuilding company

Job Description Stonhard Position Overview: Stonhard’s Construction Superintendent is responsible supervising large, sometimes multi-phase, flooring construction projects. Our Superintendent works with General Contractors, Stonhard installation partners and customers to deliver finished flooring projects at customer sites. Compensation: • Base Salary Range: $60,000 - $80,000, • Annual bonus opportunity (rookie average level) - $5,000 - $15,000, • Annual bonus opportunity (veteran average level) - $15,000 - $35,000, • Supplemental Pay Types: Commission Pay, Car Allowance, Reimbursement for Business Expenses Employee Benefits: • We invest in our people - 401K matching AND a 100% company sponsored pension plan, along with strong medical, dental & vision benefits program, • World-class training and a commitment to ongoing career development and long-term growth, • You’ll have flexibility to work from your home office when not in the field meeting clients Key Responsibilities: • Manage Stonhard flooring construction projects at customer job sites, • Manage Stonhard projects utilizing Total Project Management (TPM) guidelines, • Present and promote Stonhard’s products and services to industrial and commercial accounts, supporting Stonhard Territory Managers & Project Engineers within the region, • Duties include Material Management, Scheduling, Quality Control, Safety, Change Orders, and Post Job Reports, • Work closely with installation teams in the training and proper application of Stonhard projects Qualifications: • Two or more years of related construction project management required, • Strong oral and written communication, presentation, organization and planning skills, • Ability to thrive in a self-directed and fast-changing environment with a high degree of flexibility, • Computer literacy required, including experience with Microsoft 365, and CRM systems preferred (Salesforce), • Valid driver’s license and reliable transportation CONTACT STONHARD TODAY! Visit us online at or Apply here! After applying, we encourage you to "follow" us on LinkedIn (Stonhard) as well! This way you can stay informed and up to date on what’s happening around our organization and start your path to becoming part of our FAMILY! STONHARD is headquartered in Cherry Hill, NJ and has more than 100 years of experience manufacturing and installing high performance, seamless floor systems throughout the world. We manufacture and install long-term floor, wall and lining solutions to markets including, but not limited to: food & beverage, general manufacturing, pharmaceutical, chemical processing, education, healthcare, government, technology and hospitality. STONHARD is part of RPM International Inc., a $6.1 billion, multinational company with subsidiaries that are world leaders in specialty coatings, sealants, building materials and related services. From homes and workplaces to infrastructure and precious landmarks, RPM’s market-leading brands are trusted by consumers and professionals alike to help build a better world. We are proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. Company DescriptionStonhard is part of RPM, International (NYSE: RPM) headquartered in Maple Shade, NJ and has more than 100 years of experience manufacturing and installing high performance, seamless floors throughout the world. We manufacture and install long-term floor, wall and lining solutions to markets including, but not limited to: food & beverage, general manufacturing, pharmaceutical, chemical processing, education, healthcare, government, technology and hospitalityStonhard is part of RPM, International (NYSE: RPM) headquartered in Maple Shade, NJ and has more than 100 years of experience manufacturing and installing high performance, seamless floors throughout the world. We manufacture and install long-term floor, wall and lining solutions to markets including, but not limited to: food & beverage, general manufacturing, pharmaceutical, chemical processing, education, healthcare, government, technology and hospitality

Job Description Instrumentation Controls Technician Location: Lyndhurst, NJ Schedule: Monday – Friday | 2:00 PM – 10:30 PM (2nd Shift) Pay: $35 – $40 per hour Type: Contract-to-Hire Are you the kind of person who can look at a control panel, hear a weird machine noise, and immediately start diagnosing the problem in your head? If PLCs, instrumentation, and troubleshooting industrial equipment are your thing, this could be a great fit. We are seeking an Instrumentation Controls Technician to support a busy manufacturing facility in Lyndhurst, NJ. In this role, you will work with plant systems, instrumentation, and control equipment to ensure operations run safely and efficiently. You will also help maintain calibration programs, troubleshoot automation issues, and support plant operations when technical challenges arise. If you enjoy solving technical problems and working hands-on with equipment and control systems, this is a strong opportunity with a company that values technical expertise. What You'll Do * Troubleshoot and maintain PLC and control systems supporting plant equipment * Maintain and repair instrumentation, sensors, and electrical systems * Analyze and test computer control systems based on system design specifications * Support machine operating systems and control programs * Perform instrument calibration and calibration documentation * Manage calibration schedules and maintain compliance with ISO 9000 requirements * Diagnose issues with labeling equipment and automated systems * Perform scheduled maintenance on electrical and electronic devices * Provide rotational weekend on-call support for plant operations when required What We're Looking For * Strong troubleshooting and analytical skills * Solid electrical and controls background * Experience with PLCs (Allen-Bradley preferred) * Experience with pneumatic and hydraulic systems * Ability to read technical drawings, P&IDs, and ladder logic diagrams * Experience performing instrument calibration * Strong communication skills and ability to work independently or on a team * Experience in industrial manufacturing environments such as chemical, pharmaceutical, or food processing is preferred * Technical school training or related degree preferred * Experience with CMMS systems and smart instruments is a plus Additional Details * Schedule: Monday–Friday, 2:00 PM – 10:30 PM * Pay: $35–$40/hour * On-Call: Weekend rotation for plant support * Position Type: Contract-to-Hire * Location: Lyndhurst, NJ About Zing Recruiting Zing Recruiting is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, or any other protected status under federal, state, or local law. We are committed to fostering a diverse and inclusive workplace. #ZINGZIP #ZINGNJ Company DescriptionZing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.Zing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.

Job Description Join The WorkPlace Group’s Pharmaceutical Talent Pool! Are you a passionate professional in the pharmaceutical industry looking for your next career opportunity? The WorkPlace Group is excited to invite you to join our exclusive candidate talent pool! Why Join Us? • Exclusive Opportunities: As a Leading Recruitment Process Outsourcing (RPO) and Executive Search provider, we know about job openings before they become public. We also have direct access to the Company’s Hiring Managers and serve as their exclusive and in-house recruiter., • Priority Consideration: When a job needs to be filled, our recruiting teams first look for candidates in our database and candidate network. By sharing and uploading your resume, you can gain access to a wide range of job openings in leading pharmaceutical companies., • Pharmaceutical Professionals: Whether you’re in research, development, manufacturing, quality control, regulatory affairs, or sales, we want to hear from you!, • Common Job Titles: We frequently fill positions such as Research Scientist, Clinical Research Associate, Quality Assurance Specialist, Regulatory Affairs Manager, Pharmaceutical Sales Representative, and more. Visit our website to see a complete list of job titles., • Experienced and Entry-Level Candidates: We welcome candidates at all stages of their careers., • Upload Your Resume, • Stay Connected and follow us on LinkedIn, Instagram and X For more information, visit our website at

Job Description Trial Attorney Seeking a trial attorney with 3-5 years of experience to join a respected law firm's New York City office. This role provides the opportunity to work on a mix of commercial litigation with some exposure to intellectual property and employment matters. Responsibilities: • Conduct legal research and draft briefs, • Manage and participate in discovery, • Handle depositions and prepare witnesses, • Draft and argue legal motions, • Participate in trial preparation and trial proceedings, • Assist with appeals and appellate briefing, • Work on cases in federal and state courts, as well as arbitration Qualifications: • J.D. from an ABA-accredited law school, • 3-5 years of litigation experience, • Interest in hands-on litigation, including depositions and oral argument, • Admission to the New York Bar or ability to obtain admission promptly, • Strong legal research and writing skills, • Excellent communication skills, • Strong academic credentials, • New Jersey Bar admission is a plus #legal #midsenior #litigation #attorney Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the product and process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job DescriptionNow Hiring: Mechanics – Pharmaceutical ManufacturerPlease read the entire post; application instructions are located at the very bottom. ¡Sí, hablamos español! Shifts Available:1st Shift: 7:00 AM – 3:15 PM 2nd Shift: 3:00 PM – 11:15 PM 3rd Shift: 11:00 PM – 7:15 AM Pay Rate: $26.00 – $34.00 per hour (DOE) Locations: • East Hanover, NJ, • Whippany, NJJob Responsibilities:, • Perform preventative maintenance, troubleshooting, and repairs on production machinery and warehouse equipment., • Diagnose mechanical, electrical, and pneumatic issues to minimize downtime and ensure smooth operation of all production lines., • Assist with equipment setups, adjustments, and changeovers according to manufacturing requirements., • Inspect, maintain, and calibrate tools, machines, and mechanical components following company SOPs and GMP guidelines., • Document all maintenance activities accurately, including repairs, part replacements, and preventive maintenance logs., • Respond promptly to maintenance requests from production, packaging, or warehouse departments., • Ensure all equipment is operating safely and efficiently by following FDA, OSHA, and GMP regulatory standards., • Maintain an organized work area and support overall facility cleanliness and safety practices., • Collaborate closely with production, quality assurance, and engineering teams to resolve mechanical problems quickly.This role requires strong mechanical aptitude, problemsolving skills, and strict adherence to safety and quality standards in a regulated manufacturing environment.Requirements:, • Background check and drug test may be required., • Ability to work in a fastpaced, GMPregulated facility., • Must be able to use hand tools, diagnostic equipment, and follow mechanical diagrams., • Noise levels may range from moderate to high.What to Bring When Applying

Job DescriptionDescription: RK Pharma Inc, a US based company with subsidiaries in India, is seeking multiple Quality Assurance Associates to complement our existing Quality Assurance team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position will report to our Quality Assurance Manager and focus heavily on reviewing documentation such as batch records, internal audits, microbiology testing, and ensuring cGMP compliance. Requirements: If this sounds interesting to you, it’s probably because up to this point you have: • A science degree, specifically in Microbiology., • Have worked in a CGMP regulated environment for at least 3 years or similar educational equivalency., • Have experience with wet chemistry, HPLC, GC, spectroscopy, or microbiology., • Thrived in an environment where growth and change are rapid., • Strong Quality Control background preferred. The main responsibilities for this position are: • Review Quality Control documentation to ensure compliance with company procedures and cGMP and support issuance of CoAs and stability studies., • Revise quality and compliance standard operating procedures as required., • Review Quality Control method validation and method transfer protocols/reports., • Assist with Internal Audits., • Collaborate in management of deviations/CAPAs/change controls., • Assist in the supplier qualification of new vendors and periodical review of qualified vendors to maintain compliance., • Assist in the preparation and review of the Annual Product Review. If this sounds like something that is of interest to you, please don’t hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job Overview: We are looking for our first Technical Subject Matter Expert in Drug Product to join our team and contribute to our innovative projects and commercial production. You'll provide strategic technical input, manage manufacturing partnerships, contribute to CMC regulatory submissions, and drive product/process improvements. If you're an experienced pharmaceutical professional eager to drive innovation in drug development and ensure robust compliance, this role offers a compelling challenge. Location: Hybrid in our New York City office or Remote in the United States. Reports to: Technical Director, Manufacturing and Supply. Roles and responsibilities (Include but are not limited to): • Technical Subject Matter Expert for all aspects of Compass' Drug Products (DP) in the US in particular, and also aspects of Compass Drug Substances (DS) where appropriate, • To manage, track, and report progress on DP projects and commercial production programs, and to provide strategic and technical input to these projects/programs, • Ensure effective relationships with Compass' Manufacturing partners (CMOs/CDMOs and key suppliers) as required, meeting business objectives and timelines, • To contribute to the writing of relevant dossier sections for CMC regulatory submissions, and ensure technical compliance with recognised regulations and standards, • Identify opportunities for product and process improvements during development and scale up, • To support the Manufacturing & Supply team in any section-related activities as required and as appropriate, • To support compliance and efficiency related projects, • Identify risks, implement mitigation & controls, monitor & report status Candidate Profile: • Education level, • Minimum of Bachelor's degree in science, or equivalent, • Experience, • Demonstrated relevant experience within the pharmaceutical industry; must have DP experience across a variety of formulations and dosage forms, • Experience working with, or for, contract manufacturing organisations (CMOs/CDMOs), • Experience of contributing to CMC Regulatory content., • Experience in technology transfer, process validation and process monitoring, • Technical experience supporting manufacturing within a Quality Management System, • Ability to prioritise tasks and objectives to ensure business goals are achieved, • Specific skills, • Excellent interpersonal communication and strong Stakeholder management skills, • Knowledge and expertise in formulation of DP and dosage forms, • Project Planning & Risk Management, • Ability to react to changing priorities Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$127,500—$172,500 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Technical Source is seeking a Senior Automation Engineer / Project Manager to support a major pharmaceutical manufacturing client in Rahway, New Jersey. This role will focus on the automation design, integration, commissioning, and qualification of facility and clean utility systems, including Building Automation Systems (BAS), Environmental Monitoring Systems (EMS), and Purified Water distribution within a GMP manufacturing environment. This individual will work as part of the Capital Project Automation Delivery Team, supporting expansion projects and ensuring automation systems are implemented, tested, and qualified in compliance with GMP, data integrity, and site automation standards. Responsibilities • Support design, configuration, integration, and commissioning of facility automation systems, • Lead automation efforts for BAS, EMS, and Purified Water systems, • Partner with Engineering, Facilities, CQV, Quality, IT, OEM vendors, and system integrators to deliver automation solutions, • Participate in design reviews and system implementation activities, • Develop and execute automation validation and qualification protocols, • Support system testing, troubleshooting, and commissioning activities, • Ensure systems meet GMP compliance, validation, and data integrity standards, • Review and develop logic narratives and automation control strategies, • Interpret P&IDs, electrical schematics, and mechanical diagrams, • Support startup and qualification activities for capital expansion projects, • Bachelor's degree in Engineering, Science, or related discipline, • 7+ years of experience in automation within a biopharmaceutical or pharmaceutical GMP environment, • Hands-on experience with Siemens Building Automation Systems (BAS), • Strong experience with facility and utility automation systems, • Experience with PLC, HMI, and SCADA platforms, • Demonstrated experience writing and executing validation documentation including:, • Configuration Specifications (CS), • Functional Risk Assessments (FRA), • Automation Installation Qualification (AIQ), • Automation Operational Qualification (AOQ), • Requirements Traceability Matrix (RTM), • Qualification Summary Reports (QASR), • Understanding of the capital project lifecycle from design through CQV, • Experience working with instrumentation, process equipment, and control panels, • Ability to read P&IDs, electrical schematics, and automation logic diagrams, • Strong troubleshooting and problem-solving skills, • Experience supporting facility and clean utility systems in pharma manufacturing, • Exposure to automation for purified water distribution systems, • Experience working on capital expansion or facility upgrade projects, • Experience collaborating with CQV teams and validation groups

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-O-Vator available for use., • Small breakroom available. No on-site cafeteria available.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Client: Large Consumer Health Company Job Title – Package Engineer IV Location: Summit, NJ Job ID: 721 Pay Rate: Up to $88/hr. W2 Onsite - 100% Contract: 9 Months (Renewable) Onsite, with option to be hybrid potentially depending on performance. Ideally this person will have at least 5 years of industry experience. Description: General Summary: Provides technical expertise in the areas of design, development, testing and production scale-up of new packaging component and systems. Duties & 1. Has package development knowledge or background to execute packaging work processes for packaging projects. 2. Compiles and analyses data, identifies causes, draws conclusions and reports 3. Manages processes and ensures that activities and project goals are achieved through engagement with the X-functional team, manufacturing sites and externally with packaging vendors. 4. Responsible for maintaining compliance, consistency of practices and work quality 5. Ability to manage multiple projects simultaneously involving package development, materials selection, and manufacturing process/site changes. 6. Support manufacturing investigations, by collaborating with cross-functional teams from commercial & supply chain to execute optimization of processes, packaging materials, and constructions to enable the business innovation, GP and ESG targets. Key Responsibilities 1. Partner with the cross-functional team to execute package development activities with minimal supervision., 2. Problem-solving and critical thinking skills., 3. Demonstrates specialized knowledge, experience and skill in scientific analysis, 4. Strong project management skills, able to manage multiple priorities., 5. Leverage digital tools such as CAD, and/or modelling & simulation in projects., 6. Demonstrates flexibility and agility to manage conflicting priorities., 7. Executes projects with technical rigor and translates output into specifications., 8. Develop and drive alignment for packaging development plans with the franchise squads KPIs 1. Demonstrates understanding of packaging development work process and technical strengths to independently deliver package development activities and risk assessments., 2. Communicates (both written and verbal), to convey complex information clearly and logically., 3. Problem-solving skills, with the ability to execute tasks independently, seeking guidance as required., 4. Able to adapt and re-prioritize to changing priorities., 5. Good interpersonal skills and ability to build effective working relationships at all levels in the organization Background Education: 1. BS / MS in Packaging technology. Advanced 1. Packaging domain expertise ■ □ □, 2. Package regulation knowledge ■ □ □, 3. Knowledge of the external ecosystem ■ □ □, 4. Knowledge of digital workflows (CAD, M&S) ■ □ □, 5. Leading self □ ■ □, 6. Project Management ■ □ □, 7. Communication Capability □ ■ □ Company Description

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management:, • Documentation control (master batch record, specification and method), • Batch record review and product disposition, • Investigations, complaints, deviations, CAPAs, APRs, • Production and Pharmaceutical Development support, • APRs, GMP training and SOP review, • Validation / qualification documentation review and approval, • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site, • Develop, maintain, and enhance training programs and systems, • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives., • Must be able to move about the facility, • Experience with FDA Audit, • Extensive knowledge of US and EU current Good Manufacturing Practices, • Experience with a CDMO would be preferable, • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals Company DescriptionWe are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description ABOUT MEDSHADOW MedShadow is a nonprofit foundation that focuses on the safest ways to take over-the-counter (OTC) and prescription (Rx) medications. Medications have many benefits, but we also know that side effects can sometimes be difficult to recognize, which is why we work to illuminate and explain medication reactions that may be minimized or obscured. Our mission is to provide independent, evidence-based information. Through our service and investigative journalism, we help people make informed decisions but we also investigate improvements and reforms. We strive to use our content to stimulate public discussion about potential improvements to drug research, manufacturing and distribution processes that could potentially ensure that we are all better protected from drug harms. We do not accept or receive any financial support or funding from the pharmaceutical or supplement industries, which allows us to do our work with clarity and transparency, and without compromise. ABOUT THE ROLE In this newly created position, the Senior Director of Development is charged with conceiving, designing, building and executing comprehensive fundraising strategies that support MedShadow’s mission and growth trajectory. MedShadow seeks a strategic, creative and results-driven digital fundraiser to drive revenue through coordinated digital fundraising campaigns across digital assets, email, web, and social media. Reporting directly to the Executive Director, this individual will define scalable digital fundraising programs, grow the donor pool, deepen donor engagement, and build a revenue strategy, including a future state with grants and corporate gifts. The ideal candidate has a track record of designing and executing successful digital fundraising campaigns, knows how to move a variety of audience segments to action, thrives in a start-up environment, enjoys the agility that comes with working smart as a key player within a small team and is energized by the opportunity to innovate, create new systems and process and make a tangible impact. To excel in this role, the candidate must possess a blend of strategic digital marketing know-how, tactical expertise, innovative thinking, and proven donor engagement skills. Proven knowledge of philanthropy, fundraising tactics, and a track record of setting and then meeting/exceeding fundraising targets are essential. This position supervises one staff person. KEY RESPONSIBILITIES Strategic Leadership & Growth • Build MedShadow’s first comprehensive fundraising and development program, including strategy, systems, and infrastructure, based on best practices., • Develop and implement a diversified fundraising plan encompassing digital marketing, annual funds, grants and partnerships., • A/B testing knowledge and facility with data analytic tools to evaluate the success of various CTA outputs., • Partner with the Executive Director to identify donor growth opportunities and expand philanthropic networks., • Regularly monitor and evaluate progress toward goals and recommend new fundraising directions as needed based upon analysis of the organization’s donors and giving trends and the broader fundraising landscape., • Manage departmental budgeting and forecasting with a start-up mindset focused on efficiency and return on investment., • Participate in strategic planning to create and execute a current year, mid-range and five year view fund development vision to support organization’s plans for growth., • Assemble presentations explaining strategies, programmatic execution elements and measurement results for various stakeholders. Fundraising & Donor Engagement • Lead the creation and execution of digital fundraising including planning and optimization of campaign calendars, content strategy, and performance metrics., • Leverage technology and digital tools to reach new audiences and optimize donor experience., • Write and edit compelling, mission-aligned fundraising appeals for email, landing pages, and digital ads., • Develop segmented and targeted outreach strategies to increase donor acquisition and overall giving., • Conduct A/B testing and analyze campaign performance to improve open rates, click-throughs, and conversions., • Identify, cultivate, solicit, and steward relationships with individual, partner, and foundation donors., • Collaborate with leadership on high-level donor meetings, proposals, and presentations., • Experiment with varied approaches to fundraising, such as peer-to-peer fundraising, ambassador programs, and impact storytelling., • Conduct research, writing, and reporting of grants with a focus on alignment to organizational priorities. Marketing & Communications Alignment • Supervise and develop a team member and vendor partner(s) to ensure fundraising and communications strategies are integrated and mutually reinforcing., • Work with the team to align and affirm consistent definition and deployment of brand positioning, digital presence, and storytelling that strengthens donor engagement and awareness. QUALIFICATIONS • 7–10 years of progressive fundraising experience, including individual giving, institutional fundraising, and donor relations., • Experience in healthcare, disease state, science, health equity, consumer advocacy or a related sector., • Commitment to organization’s mission., • Mastery of digital fundraising strategy, tactical planning, execution and data measurement., • Proven experience creating strategies and plans to maximize online channels like social media, email campaigns, websites, and digital ads to promote a nonprofit's mission, engage supporters, and drive donations and participation., • Track record of building fundraising infrastructure or launching new fundraising initiatives., • Proven success in securing and stewarding partnerships and grants., • Strong leadership and management skills, with experience supervising staff or consultants., • Excellent written and verbal communication, relationship management, and storytelling abilities., • Experience vetting, implementing and using donor CRM platforms (e.g., Salesforce, Bloomerang, DonorPerfect)., • Comfort operating in a dynamic and growing start-up environment., • Comfort level with medical and/or scientific research, lexicon, practices., • CFRE or other fundraising certification is a plus., • Bachelor’s degree or equivalent combination of education, training, and experience are encouraged to apply. IMPORTANT THINGS TO KNOW • Annual salary is $118,000, • Location: NYC or within commutable distance, • This position is remote with willingness/ability to meet/work onsite in NYC, on short notice, as required by the Executive Director which will be variable (e.g., sometimes once a week or once a month as needed), and all commuting costs to the office for meetings will be at the expense of the employee. Interested candidates should apply by using the application form. Chaloner will review all applicants and, upon qualification, contact you to determine next steps.

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Electrical Factory Inspector (Remote/Travel) responsibilities include, but are not limited to, the following: • Support department objectives and company goals, • Be a team player, • Sustain a positive, enthusiastic and professional attitude at all times, • Accommodate requests with a smile and “let me see what I can do” attitude, • Adhere to manager directives, • Maintain a professional appearance and demeanor, • Arrive on time, properly dressed and prepared to work, • Perform all duties in a timely, accurate, honest and professional manner, • Communicate with customers professionally and in accordance with customer service standards, • Surveillance inspections of factories to assure products remain in compliance with conditions of granted certification., • Other duties assigned by management.Qualifications Basic Minimum Education Qualifications: • Knowledge of electronics, • Certification in Electronics, ideal but not required, • Willing to travel - This position requires 90% - 100% travel, • Able to rent a car, • Willing to work overtime and remote, • Cannot be on any no fly list, • Clean driver record, • Ability to maintain confidentially, • Needs to be receptive to and accepting guidance from others, • Ability to deal with difficult people and problems, • Able to work well in a team environment, • Able to work in a diverse group of people, • Attention to detail, • Ability to multi-task and prioritize assignments, • Able to sit or stand for long periods of time, • Able to lift up to 30 pounds Additional Information Position is full-time travel & hybrid, working Monday - Friday 8:00 am to 5:00 pm, with overtime as needed. • Compensation: $50,000 - $70,000, • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Production Technician I is responsible for the aseptic manufacturing of Cresilon’s products for the animal health industry. The Production Technician II will be trained in clean room operations, aseptic techniques, and must demonstrate the ability to successfully pass gowning qualifications. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will have a proven track record of steady progress in a similar manufacturing environment and must possess a willingness to learn all equipment and jobs in the assigned manufacturing and sanitation of clean room facilities as required. Production Technicians are also responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP). • Perform line clearance of assigned production areas as required., • Perform equipment set up and disassembly activities., • Operate production, assembly and testing equipment, including heat sealers, bar code scanners, weighing scales, tumblers, autoclaves, filling equipment, and packaging equipment., • Formulate, fill, and pouch product in accordance with SOPs., • Troubleshoot all operating deviations and issues and coordinate with other functions when required., • Report both machine and operating deviations to area supervisor or designee., • Perform routine, preventative maintenance on equipment., • Perform cleaning and disinfection of the manufacturing spaces., • Perform cleaning and sterilization of manufacturing equipment., • Perform visual inspection of components and/or product in accordance with SOP’s and cGMP’s., • Perform sampling, intermediate, and finished goods packaging as per SOPs., • Package and ship raw materials for sterilization., • Perform material receiving, staging, material movements, and material replenishment as per SOPs., • Transport samples, materials, and equipment between multiple facilities., • Complete data entry and generate reports for material inventory movements., • Complete and maintain applicable logbooks and batch record paperwork as required and in accordance with GMP and GDP standards., • Maintain a clean production environment during shift., • Report all actual, near misses and potential accidents for further investigation., • Take immediate action to resolve any near miss situations., • Assist in investigation of all actual, near misses and potential accidents. Provide information to troubleshoot and take initiative to resolve operational issues independently., • Assist in project commissioning and validation activities, as necessary., • Prepare samples or prototypes as required for testing, or other evaluations, • Monitor the plant status and liaise with colleagues of other departments to ensure there is no interruption to manufacturing process., • Complete all required trainings: Read and Understand (TM1), Computer Based Training with Quiz (TM2), Instructor Led (TM3/TM4), and On-the-Job Trainings (TM5)., • Oversee training of junior employees on production processes as assigned., • Ensure proper communication and handling over of shift duties., • Support Environmental and Personnel Monitoring (EM/PM) activities as directed., • HS Diploma or Equivalent with 2+ years of relevant manufacturing experience in the pharmaceutical, biotechnology, or medical device industry OR 2 or 4 year degree with 0+ years of relevant experience., • Ability to read, understand, and execute written work instructions., • Ability to complete documentation accurately., • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals, • Ability to become gowning qualified to work in a cleanroom environment., • Ability to problem solve and achieve business objectives., • Ability to adapt training approach., • Willingness to be flexible, and open minded to new processes or changes in direction., • Team oriented, building relationships with peers and managers in a proactive manner., • Excellent verbal and written communication skills., • Proficient in Microsoft Office (Word, Excel, Outlook)., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Monthly MetroCard Reimbursement This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job DescriptionDescription: AAF International offers the most comprehensive clean air solutions available across the globe. Selling under the American Air Filter® and the AAF International® brand names, AAF International has been an industry pioneer since 1921 with manufacturing operations in 22 countries and over 6000 employees globally. Our products are the industry benchmarks for quality and performance. Our applications include commercial, industrial and residential solutions from the filters used in your home to the most critical cleanroom and power generation applications. We are a member of the Daikin Group, the world's largest air conditioning provider with $30 billion in revenue and over 98,000 employees worldwide. Founded in 1924, Daikin has grown into a diversified industrial manufacturing company offering solutions in clean, air, air conditioning, refrigeration, chemicals, oil hydraulics, defense systems and electronics. Our culture of continuous improvement, safety and world class operations is driven by our people-centered management philosophy. This philosophy is built around mutual selection: that while AAF seeks top talent people to join and deliver on our team, we also want each team member to receive job satisfaction, growth & development, and continued happiness in being a long-term member of the AAF family. This is fueled by our belief in treating our people, our supply partners, our customers and our environment with the trust and respect we each require, and our passion to give back to our community for our success. Read more about our philosophy at: AAF International is an Equal Opportunity Employer M/F/Disability/Veteran. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, sexual orientation, gender identity, national origin, citizenship, veteran status, uniform servicemember status, age, disability or any other legally recognized protected personal characteristics. Position Objective: This position will report to the regional branch in New Jersey and work out of their home, ideally located in the territory. The territory for this position covers Nassau and Suffolk counties and the outer boroughs of Queens, Brooklyn, Bronx and Staten Island. Achieves maximum sales profitability, growth and account penetration within an assigned territory and/or market segment by effectively selling the Company’s products. Contacts and secures current and new business accounts/customers. Key Accountabilities: • Promotes/sells/secures orders from existing and prospective customers through a relationship-based sales approach highlighting the advantages/value proposition., • Demonstrates products to existing and potential customers and assists them in selecting those best suited to their needs., • Manages sales goals - profit and budget expenses., • Establishes, develops and maintains business relationships with current customers and prospective customers in the assigned territory/market segment to maintain current and generate new business., • Researches sources for developing prospective customers and for information to determine their potential., • Develops clear and effective written proposals and quotations for current and prospective customers., • Expedites the resolution of customer problems and complaints., • Coordinates sales effort with marketing, sales management, accounting, logistics and technical services., • Analyzes the territory/market’s potential and determines the value of existing and prospective customers to the Company., • Creates and manages a customer value plan for existing customers highlighting sales profile, share and value opportunities., • Provides management with detailed information on customer needs, problems, interests, competitive activities, and potential for new products., • Stays current with product applications, technical services, market conditions, competitive activities, and marketing trends and activities., • Participates in trade shows and conventions as required., • Perform other related duties as assigned as required. Requirements: Position Requirements: • Bachelor’s degree from an accredited university in Business or related field preferred;, • 5+ years' prior selling experience;, • Understanding and experience with high value-added product selling, pricing, and negotiation;, • Experience selling to healthcare and pharmaceutical facilities a plus;, • Ability to communicate a technical concept or value added benefit to achieve buy-in from diverse teams to meet sales targets and profitability;, • A history of consistently delivering on expectations for growth and profitability must be demonstrated;, • A team player that possesses a natural way of influencing, both internally and externally;, • A self-starter with a creative eye to implement marketing and promotional campaigns designed to achieve specific growth objectives regionally and nationally;, • Must be proficient in Microsoft Office (Word, Excel, PowerPoint);, • SAP or CRM experience, Salesforce preferred.

Job Description SOKOL GxP Services is seeking an Associate Scientist/Engineer to join our on-site team in Summit, NJ. This role is integral to supporting oral solid formulation studies, working hands-on in laboratory and pilot plant settings. You will collaborate with cross-functional teams and travel between Summit and New Brunswick sites as needed to access specialized equipment and facilities. Key responsibilities include: • Executing laboratory and pilot plant work to establish oral solid formulations;, • Designing and conducting experimental formulation studies;, • Performing material characterization and formulation testing;, • Developing and optimizing oral formulations using a design of experiments approach;, • Utilizing HPLC and dissolution testing techniques for oral formulations;, • Tracking and trending data for formulation development projects;, • Communicating effectively and transparently with peers and cross-functional partners;, • Bachelor’s degree in a science or engineering field;, • 0–3 years of relevant experience in pharmaceutical formulation, laboratory, or pilot-plant work (internship experience acceptable);, • Hands-on experience performing HPLC and dissolution testing for oral formulations;, • Experience working in cGMP/FDA-regulated pharmaceutical manufacturing environments (internship experience acceptable);, • Ability to travel between Summit, NJ and New Brunswick, NJ sites as needed.Preferred Qualifications:, • Advanced degree in a science or engineering field;, • Experience with oral solid formulation development;, • Experience with material characterization techniques such as DSC and/or TGA;, • Experience using Design of Experiments (DoE) to design and optimize formulation studies; Competitive hourly rate: $28 – $35.56/hr (W-2 only, no C2C) Working Hours: Monday - Friday, regular business hours 8-month contract with possible extension Health insurance, holiday pay, 401(k) program, and other benefits Employee referral bonus program

Job DescriptionQuality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical Scientist will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle. • Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients., • Support routine GMP testing as assigned. Mentor and train team members, • Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements., • Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports., • Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data., • Identify, evaluate, and implement continuous business process improvements., • Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS)., • Provide support during laboratory investigations., • Train QC personnel during method transfer and validation. Provide support during equipment qualification., • Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices., • Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures., • Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing.REQUIREMENT, • B.S Analytical Chemistry or other scientific field or MS/Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products., • 8-10 years of experience in the areas of method development, validation, and transfer., • Direct GMP Experience., • Proficiency in project management skills and tools., • Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc., • Extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs., • Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required., • Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution., • Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team., • Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction., • Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external., • Must be familiar with GMP lab environment and Aseptic techniques.Working EnvironmentMust have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays, or overtime and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facilityMay work with hazardous materials and chemicals Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionNow Hiring: QA Inspectors – Pharmaceutical Manufacturer Please read the entire post, application instructions are located at the very bottom. ¡Sí, hablamos español! Shifts Available: • 1st Shift: 7:00 AM – 3:15 PM, • 2nd Shift: 3:00 PM – 11:15 PM, • East Hanover, NJ, • Assemble and label medication packages, ensuring accurate counts and proper documentation., • Inspect finished products for accuracy, appearance, labeling, and functionality., • Follow Good Manufacturing Practices (GMP) and all regulatory guidelines to maintain safety and compliance., • Collaborate with quality assurance, production, and maintenance teams to support efficient operations., • Background check and drug test may be required., • Must be able to work in a fastpaced, GMPregulated environment. #ZIP

Job DescriptionDescription: RK Pharma Inc, a US based company with subsidiaries in India, is seeking a Microbiologist to join our growing team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. The position will perform all QC-Microbiology related testing activities such as Environmental, Water, and API and Drug Product release testing activities for RK Pharma. The position leads and supports the development, implementation, and maintenance of Quality Control (Microbiology) systems and activities for RK Pharma. This position is in Pearl River, New York, and is required to be onsite. Requirements:

Job DescriptionDescription: RK Pharma Inc, a vertically integrated pharmaceutical company with our main manufacturing site in Pearl River, NY, is seeking a Quality Control Chemist to work with our growing Quality Teams as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. Requirements: If this sounds interesting to you, it’s probably because up to this point you have: • Bachelor of Science of higher, • 0-3 years of quality Control experience, preferably in a pharmaceutical, manufacturing, or regulated environment., • Familiarity with cGMP, GDP, and standards., • Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and experience with ERP or document management systems (e.g., SAP, Master Control)., • Excellent organization, time management, and communication skills. The main responsibilities for this position are: • Perform daily verification /performance check of the QC analytical instruments such as Analytical balance, Microbalance, KF titrator, KF coulometer, Auto titrator etc.,, • Perform calibrations of all the QC analytical instruments/equipment’s as per the calibration calendar schedule or when required., • Perform Instrument/ equipment performance qualification as and when required., • Maintain inventories of chemicals, Standards, samples etc.,, • Operation, calibration, maintenance and qualification of all analytical instruments such as HPLC, GC, TOC, UV, IR, automatic titrator, dissolution equipment, etc., • Follow the procedures as per the SOP’s/ guidelines., • Perform Sampling of raw materials, drug substance, packaging components, stability samples, cleaning samples, In-process samples and finished products., • Perform analytical tests and wet chemistry tests on raw materials, drug substance, packaging components, stability samples, cleaning samples, In- process samples and finished products in compliance with the STP and SOP’s., • Follow and document all test results under GLP, GDP, GMP and Lab Safety guidelines., • Document test results, problems and other issues, perform troubleshooting of issues that arise during analysis., • Logging various samples received to QC as per the SOP into their respective log books., • Monitors Stability chambers, Photostability chamber, freezers, refrigerators etc., • Performs Stability samples loading/charging and pull-out according to the stability calendar., • Record the results and prepares CoA to be released in a timely manner., • Perform analysis using various software’s such as Empower, Tiamo, Spectrum two, Flex etc., • Write and perform investigation of out of specification results., • Train other QC chemists in a timely manner on all the general Laboratory SOPs and test methods., • Preparation and review of Standard Operating Procedures, specifications and STP’s for Raw materials, Packaging components, drug substances and finished products (based on ICH/Pharmacopeial reference)., • Preparation and execution of protocols for Method Validations, Method Transfers, Cleaning Validation, Raw material qualifications, Stability studies and any other studies., • Maintains lab, instruments, logbooks and notebooks at all times., • Maintains lab instruments and performs calibration/preventive maintenance to ensure proper working order and troubleshoot when necessary.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters. Responsibilities • Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information., • Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions, • Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies, • Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings., • Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests., • Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions, • Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization, • Develops, implements, and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC., • Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company., • Trains, develops and mentors individuals; may include formal supervisory responsibilitiesQualifications, • Required Education: Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject., • Preferred Education: Relevant advanced degree preferred. Certification a plus., • Required Experience: 8 years pharmaceutical with at least 3 years of demonstrated leadership, • Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing., • Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority., • Experience working in a complex and matrix environment., • Strong oral and written communication skills., • Note: Higher education may compensate for years of experience Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionJob Description The Jr. Sales & Project Coordinator is responsible for reliable manufacturing coordination. They act as an interface between customers and internal departments. They play an important role both in customer-specific issues and in the supply chain in order to achieve the optimum between meeting customer requirements and economic results for Schreiner Group. The link between our US sales team, and customers throughout the Americas is vital to our stability, and projected growth. Our production facility in Blauvelt, NY acts as the US headquarters, with a dotted line reporting to our German parent company. This position will have direct contact with customers, internal team members, and business partners as well as regular interaction with peers located in at our German headquarters. This role has a career path through Sales & Project Management as dictated by business need. At Schreiner Group, we are grateful for our current stability, and excited for our projected growth in the coming years! Primary Responsibilities • Customer correspondence, • Participation in internal and external customer (on occasion) meetings, • Negotiations as part of day-to-day business (e.g. telephone follow-up on quotations, simple price discussions, negotiations on delivery date postponements), • Case-by-case support during complex price negotiations, • Participation under guidance e.g. in NDAs, Supply Agreements, Quality Agreements, Development Agreements, • Receive simple customer inquiries and prepare quotations with guidance, • Creating orders using existing master data structures; in series business with existing customers: Checking contracts under supervision (e.g. payment terms, incoterms, creditworthiness check), • Independent artwork management, • Independent and error-free order entry and order creation for reprints and new types in the ERP system, taking into account the valid guidelines; independent checking of the order with regard to the valid contracts/agreements; informing the internal/external contacts in the event of deviations after consultation, • Identification/tracking of deviations in post-calculations; invoice release/correction, • Confirmation of delivery dates to customers; review of order confirmation within the framework of valid contracts/agreements; in the event of deviations, use of the regulated escalation process, • Active participation of all types of complaints for assigned customers, • Operate established supply chain service solutions as part of customer support, • Participate in supply chain workshops; participate in supply chain calls with customers, • Perform external customer projects under supervision, • Contribute on a case-by-case basis to sales tools such as Sales Funnel, Key Account Development Plan, Country Management Plan., • Bachelor's degree in business, or related field, • May be supplemented by an associate's degree plus relevant work experience, • Experience supporting a sales team in a manufacturing environment, • Experience as primary point of contact for B2B customer service, • Experience working in SAP and/or CRM systems which feed to SAP, • Participation in ERP implementation, master data transfer/maintenance, and similar, • Experience working in a pharmaceutical manufacturing environment; including supplier relationship, • Experience developing or facilitating training material, supervising staff, or onboarding new team members

Job DescriptionDescription: Celularity Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous cell therapies derived from the postpartum placenta. Celularity leverages the placenta’s unique biology, immunologic properties, and scalable availability to develop therapeutic solutions targeting fundamental mechanisms of aging and age-related disease. Summary: Celularity is seeking an Associate Director Engineering to join our facilities operations team in Florham Park, NJ. The incumbent is responsible for performing highly diversified duties required to operate and maintain facilities mechanical systems including boilers, HVAC systems (air handlers/chillers/humidifiers/AC units/exhaust systems/associated controls), compressed air, bulk gas systems, generators, electrical, plumbing, etc. This position includes managing/ supervising staff level building engineers/mechanics as well as critical oversight of contractors. The position also provides first response technical support and planning to maximize equipment uptime, evaluating equipment failures while analyzing performance and being involved in design improvements to increase the reliability of our assets. This position will also include conducting Preventive Maintenance (PMs) and repair of various facilities systems as well as supervising and overseeing contractors to ensure proper performance and quality workmanship that meets our scheduling milestones and budget limits. • Manage, lead and develop staff building mechanics and engineers in the preventive and corrective maintenance of all facility systems to sustain and improve overall facility uptime and safety objectives., • Oversee external service providers for equipment maintenance, HVAC, etc., • Troubleshoot, repair, maintain, and improve mechanical equipment and components., • Maintain boilers, compressors, vacuum pumps, HVAC systems, humidifiers, etc., • Utilize our asset management software to document proper maintenance of equipment, identify equipment problems, obtain parts, document findings, track labor hours and material on jobs, capture repair history, etc., • Support and supervise after-hours response to emergencies and take appropriate action to identify problems and take corrective actions., • Review, execute and approve work orders, logs, forms and related documentation on a daily basis to ensure they are complete, current, and reflect the tasks as performed, and are appropriately filed in., • Recommend and assist in executing facility expansions and improvement projects through effective project oversight and cost control., • Promote working safely, conducting inspections, resolve conflicts to protect employees’ health and wellbeing., • Adhere to budget in areas of facility expenditures, • Provide engineering support, technical expertise and problem solving to all departments., • Provide technical expertise and recommendations for facility improvements., • Gather and analyze data, blueprints, and reports., • Analyze condition, troubleshoot failures, perform facility and infrastructure repairs., • Manage, lead, and develop facilities mechanics and building engineers., • Utilize Siemens Building and Environmental Management to investigate alarms and resolve any related systems issues to maintain proper environmental controls in regulated pharmaceutical cleanroom environments., • Comply with relevant regulations, building codes and EHS standards., • Collaborate and support other departments within Celularity for special projects as necessary. • Ten (10) years overall technical experience with minimum of two (2) years’ experience in a manufacturing facility, preferably in a pharmaceutical cGMP environment. Preferred Qualifications: • Bachelor’s degree in engineering, Science, Environmental or Occupational Health Sciences, or a related field required (or equivalent degree with experience), • NJ Building Operating Engineer License and/or Black Seal license, • Ability to read and understand mechanical and electrical drawings., • Ability to communicate, both written and oral, technical information to a diverse audience, • Possess good documentation skills This position will require: • Weekend work/Off Hour Response, • Working overtime, • Working on holidays as needed Physical Work Abilities and Requirements: This position requires frequent walking, climbing, bending, kneeling, lifting, stooping, and working/extending overhead, including: • Frequent physical demands including lifting up to 50 lbs., • Using ladders up to 20 ft and working from heights., • Climbing a ladder and work from lift, • Must pass background, drug/alcohol screening.

Job Description Senior Civil Engineer – Airport Infrastructure Airside | Landside | APM Systems In-Office | New York City | $120,000–$140,000 Senior Civil Engineer needed for airport and aviation infrastructure projects supporting major expansion and modernization programs at active commercial airports. This role focuses on civil design inside operating airport environments including terminals, airside/landside interfaces, and Automated People Mover (APM) systems. Work supports large capital programs for airport authorities across the United States. Airport project experience is required. What You’ll Work On • Airport expansion and terminal-area civil infrastructure, • Airside and landside development within active airports, • APM systems including guideways, stations, and supporting civil infrastructure, • Airport grading, drainage, utilities, and pavement interfaces, • Civil design for complex airport capital improvement programs, • Coordination with airport authorities and multidisciplinary teams, • Construction-phase support for airport projects Requirements • Direct experience on airport or aviation infrastructure projects required, • Bachelor’s Degree in Civil Engineering, • 7+ years civil engineering experience on airport, aviation, or major transit infrastructure projects, • Experience with airport civil design including APM systems, guideways, stations, utilities, grading, drainage, or pavement, • Experience working within active airport environments, • Knowledge of airport design standards and agency coordination, • AutoCAD and Civil 3D proficiency, • U.S. Citizenship or Permanent Residency, • Ability to travel to airport project sites as required, • EIT required | PE preferred Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Electrical Estimator Electrical Contracting – Electrical Construction (Commercial & Industrial) We are seeking a motivated Electrical Estimator with 1–5 years of experience to join a growing commercial/industrial electrical contracting team. This role is ideal for someone looking to build a long-term career in estimating and preconstruction, working on projects typically ranging in the $100K to $3Million dollar area. You will support senior estimators and project teams in preparing accurate, competitive bids while gaining exposure to a wide range of electrical construction projects. This is a strong opportunity for someone earlier in their career to learn from senior team members, gain exposure to larger projects, and grow into a high-impact role within a reputable electrical contractor. Key Responsibilities • Assist in preparing accurate cost estimates and bid proposals for commercial and industrial electrical projects, • Perform quantity takeoffs from drawings, specifications, and bid documents, • Analyze blueprints, electrical plans, and project specifications, • Solicit and review vendor and subcontractor quotes, • Support the development of labor, material, and equipment cost estimates, • Use estimating software (e.g., Accubid, ConEst, McCormick) to build estimates, • Collaborate with project managers, engineers, and field teams, • Participate in pre-bid meetings and site walks as needed, • Help maintain and update cost databases and historical pricing, • 1–5 years of experience in electrical estimating or electrical construction (field experience is a plus), • Knowledge of commercial and/or industrial electrical systems, • Ability to read and interpret electrical drawings, specifications, and one-line diagrams, • Familiarity with estimating software such as Accubid, ConEst, or McCormick, • Proficiency in Microsoft Excel and Office Suite, • Strong attention to detail and organizational skills, • Effective communication and teamwork abilities, • Understanding of NEC codes and construction practices, • Experience working for an electrical contractor / electrical construction firm, • Exposure to projects such as:, • Office buildings, • Warehouses / distribution centers, • Manufacturing facilities, • Competitive base salary, • Comprehensive benefits package (medical, dental, vision), • 401(k) with company match, • Paid time off and holidays, • Clear career growth path into Senior Estimator or Project Management, • Stable backlog of commercial and industrial work #Construction #Associate #LI-AS1 Key Words: MEP, Electrical Construction, Electrical Contractor, Electrical Project Manager, Project Manager, Estimator, AccuBid, ConEst, McCormick, EBM, Electrical Bid Manager, Electrical Contracting, OST, On-Screen Takeoff. Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job DescriptionJOB DESCRIPTION:The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience 2+ years of RadioPharmaceutical and Quality Assurance experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

Job Description We’re seeking a Warehouse Group Leader to oversee inventory handling, personnel coordination, and day-to-day warehouse operations within a food-grade manufacturing environment. This role requires strong leadership, attention to detail, and the ability to manage product flow, documentation accuracy, and compliance with all food safety, GMP, and company standards. You’ll lead a shift of warehouse personnel, ensure accurate receiving and inventory control, coordinate outbound shipments, and support safe, efficient warehouse operations. Compensation • $22 hr, • Shift Leadership & Team Coordination – Assign tasks, supervise warehouse personnel, provide training, and ensure smooth shift operations. Step into full departmental responsibility when the Warehouse Manager is absent., • Receiving & Inventory Management – Receive finished goods, verify materials against invoices, maintain accurate inventory counts for raw, packaging, and finished goods, and ensure all items are properly tagged, labeled, and stored., • Shipping & Material Handling – Oversee loading and unloading of freight, ensure FIFO is followed for incoming and outgoing products, coordinate transportation schedules, and validate outbound accuracy., • Compliance, Documentation & SAP Use – Maintain complete and accurate paperwork for all inbound/outbound transactions; operate SAP warehouse applications and handheld scanners for receiving, posting, and tracking materials., • Quality, GMP & Food Safety Standards – Ensure all warehouse activities follow GMP, food-safety, and safety guidelines. Maintain a clean work area, ensure tools/equipment function properly, and immediately report discrepancies or damages., • Forklift Operation & Safety – Complete forklift and trailer inspections, maintain a zero-damage standard, and uphold a clean safety record in accordance with company policies., • Supplier & Customer Coordination – Communicate with suppliers regarding delivery schedules, prepare product samples as needed, and assist in reviewing open sales orders to ensure adequate inventory allocation Qualifications • Experience – Minimum 2 years of warehouse experience in a manufacturing environment, ideally within food, pharmaceutical, or nutraceutical industries., • Leadership & Teamwork – Demonstrated ability to lead a shift, train staff, delegate tasks, and maintain smooth warehouse operations., • Technical Skills – Experience with handheld scanners; ability to use SAP or similar warehouse management systems; strong understanding of inventory practices and FIFO., • Forklift Certification – Valid forklift license/certification with a strong safety record., • Documentation & Compliance – Ability to complete and manage paperwork accurately while following SOPs, GMPs, and food-safety guidelines., • Communication – Ability to read, write, and speak English effectively; strong coordination and reporting skills., • $22 hr, • Medical, dental, vision

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSummary: The Account Manager will work as a field representative of Apotheco Pharmacies to ensure a positive customer experience and improve utilization where applicable. Account Manager will be solely responsible for customer relations within the designated Central NJ territory . Account Manager will work with District Manager and necessary Pharmacists on business plans for maintaining and developing current customer base. Account Manager will manage time in field and administratively to meet requirements of account maintenance and development. Education/Experience/Training: • Strong Communication skills, • Ability to effectively develop and build relationships with customers/individuals at all levels of an organization., • Proficient in Word, Excel, and ability to learn necessary programs for sales tools., • 2-5 Years of relevant field sales experience Account Management: • Plan, strategize and execute necessary territory objectives to meet all sales goals as set by the managements team., • Understand pharmacy programs, operations, and necessary offers to effectively communicate pharmacy benefits and services., • Quickly learn and understand new initiatives, programs and / or pricing changes., • Ensure all field materials are current week to week., • Identify marketing needs and proactively bring to management., • Lead and execute development of project goals and timelines for accounts., • Assist with executing new programs/initiatives at all pharmacies/accounts., • Operate as the lead point of contact for accounts within specified geography for all matters related to pharmacy utilization., • Build daily and weekly schedules to meet with accounts., • Understand the unique features of each account/practice., • Acts as a consultative business partner, continually identifying opportunities to improve the customer’s business through increased utilization of service/programs/solutions., • Takes lead on operational management of onboarding new accounts., • Clearly communicate the services our pharmacy locations can offer patients/accounts and uncover how our services match account needs., • Develop plans alongside account decision makers/ providers for improved utilization., • Collaborate with providers and staff to improve pharmacy communication., • Build out customer profiles for pharmacists and pharmacy technicians., • Along with Pharmacist, identify areas of improvement within accounts., • Collaborate with pharmacists at each location to create short- and long-term plans. Identify accounts for maintenance, growth, and new business on a quarterly basis., • Collaborate and communicate with Pharmacist/Pharmacy techs as needed., • Facilitate account education events as needed., • Effectively collaborate with industry colleagues including pharmaceutical & manufacturing partners., • Account Manager will have regular meetings with Business Development Manager and Pharmacist to review accounts, present on current account standings and possible business strategies., • Coordinates closely with Pharmacists for unified communication to accounts. Math Ability: Ability to comprehend and apply principles of basic math while analyzing data and generating reports. Reasoning Ability: Ability to apply principles of logical thinking to a wide range of intellectual and practical problems. Computer Skills: To perform this job successfully, an individual should have some previous experience with software products, preferably purchasing software, in addition to working knowledge of Microsoft products, especially Excel and Word. Information Security Expectations: While performing the duties of this job, the employee is required to abide by Apotheco information security policies, employee handbook and security and privacy regulatory requirements. Each employee is responsible for the secure and appropriate handling of Apotheco information, information received by customers, other companies and/or external parties. Knowledge, Skills, and Other Abilities: • Time management, • Oral and written communication skills, • Professionalism, • Organization skills, • Customer Service, • Prioritizing skills, • Detail oriented, • Multi-task abilities, • Goal oriented, • Dependable, • Confidentiality, • Self-motivated, • Ability to work well with various personalities and within a team., • Participate in continuous quality improvement activities Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to walk; sit and use hands. The employee is occasionally required to stand.

Job DescriptionLitigation Paralegal Scarsdale, NY · On-site · Full-time $60K–$80K/yr · Easy Apply We’re seeking a motivated Litigation Paralegal to join a busy, collaborative law team in Scarsdale, NY, an attractive and convenient location with a vibrant community and excellent amenities. About the Role As a Litigation Paralegal, you will support multiple senior attorneys by preparing, filing, and coordinating legal documents, managing busy calendars, maintaining case files, and assisting with depositions and court proceedings. This role combines hands-on legal work with administrative responsibilities in a fast-paced but collegial environment. Key Responsibilities: * Serve as primary paralegal for multiple senior litigation attorneys and handle all paralegal work on their cases. * Finalize, format, file, and serve legal documents; prepare tables of contents and authorities. * E-file in federal and state courts, prepare courtesy copies, and assist with ADR proceedings. * Arrange depositions and assist with preparation, including exhibits and binders. * Maintain attorney calendars, deadlines, and case files—both physical and electronic. * Prepare simple legal documents using firm templates (subpoenas, discovery demands, court forms). * Assist with document productions, Bates stamping, and conflict checks. * Answer firm phones and manage incoming mail as needed. Requirements: * 1–2 years of paralegal or legal assistant experience. * Advanced MS Word skills. * Experience e-filing in NY/NJ state and federal courts; PA courts a plus. * Familiarity with law firm CRM/document management/time entry systems (NetDocs and Finance Core a plus). * Proficiency with Westlaw research and cite-checking. * Superior organizational skills, attention to detail, and ability to multitask. * Positive, team-oriented attitude and willingness to work overtime as needed. Why You’ll Love Working Here: * Fast-paced but supportive and collegial environment. * Opportunity to grow professionally with senior attorneys. * Convenient location that is beautiful, walkable, with excellent schools, dining, and commuting options. An Equal Opportunity Employer committed to diversity in the workplace. We celebrate the unique contributions that each team member brings to our organization. Please reach out for additional info. I have over 100+ roles open daily! Please add me on Linked in. ---No Third Parties--- Michael Sardella| Liberty Personnel Services, Inc. 1001 Conshohocken State Rd, Ste 2-410| West Conshohocken, PA 19428 #newyork #junior #litigation #paralegal Company DescriptionLibertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move! Hundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month. Established in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on: Information Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.Libertyjobs.com has become an essential destination site for experienced job seekers. Our recruiters are continually posting active job openings to the website. Feel free to search our database of open positions and apply for your next career move!\n\nHundreds of new jobs are listed on the site every month in a wide range of industries and locations. Last year we had over 900,000 unique job seekers visit our website, which means over 75,000 skilled job seekers search our openings every month.\n\nEstablished in 2003, Liberty Personnel quickly grew into one of the largest technical recruiting agencies on the East Coast. Today, Liberty Personnel has a national presence and a diverse client base. Listed below are a number of the industries and openings we work on:\n\nInformation Technology, Software Programmers, Engineering, Manufacturing, Legal, Plant Maintenance, Construction, Oil and Gas, Medical Communications, Accounting, Finance, Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin, Automation, Controls, Civil, HVAC, Wastewater, Structural, Electrical, Chemists, Validations, Logistics, Food Production, Renewable Energy and Machinists.

Job DescriptionJob Summary: Instrument and Controls Engineer:The Instrument and Controls Technician is involved with the successful daily operation of the oil refining facility, and the modification and alteration of the plants automated control and power systems to accommodate business needs and ensure high plant availability. This requires close collaboration with other employees and management staff to ensure safe work and to set or re-set job priorities. Documentation, as required to document changes in plant physical or logic changes, and documentation to meet our goals of safety first, quality work and compliance with our customers’ requirements and concerns. Qualifications: Instrument and Controls Engineer: • High School Diploma or GED with at least 10 years I&E (I&C) experience in a chemical, food, pharmaceutical manufacturing environment. Familiarity with PLC based controls systems such as GE or Allen Bradley in a manufacturing environment., • Ability to analyze and interpret technical problems related to instrumentation or PLC logic., • Ability to read and understand company policies and procedures, technical datasheets or literature, P&IDs, electrical drawings (One-line drawings, loop drawings, control circuits, etc), • Ability to effectively present information either verbally or via written document (e-mail, MS Word/Excel, CMMS, etc) and respond to questions from groups of managers, co-workers, customers, and the general work force., • Ability to work with and apply mathematical concepts to practical situations., • Preferred: New Jersey Licensed Electrician (or working towards license), • Preferred: ISA Certification (Certified Control System Technician, Certified Industrial Electrician, Certified Instrument Technician)Duties & Responsibilities: Instrument and Controls Engineer:, • Monitor, repair, maintain and troubleshoot all field instrumentation, electrical equipment and controls systems including plant safety systems and plant power systems., • Install, loop check, maintain and troubleshooting process control systems comprised of transmitters, controllers, and valves operating in a PLC system., • Calibrate, monitor, repair, maintain, label and document all field instruments such as transmitters, controllers, valves, PLCs, plant safety systems, plant power systems, utility systems (HVAC), pH and conductivity meters, • Install, maintain, and troubleshoot electrical distribution and protection circuits up to 480VAC., • Fabricate and install rigid and flexible conduit, and run power and control wiring based on electrical code requirements, • Properly select, install and wire 120V-480V motors, single phase to three phase based on needs, • Strong working knowledge of National Electrical Code (NFPA 70), • Evaluate current instrumentation technology for process equipment and make recommendations for improvements., • Ensure all work orders are completed, documented and closed out in the site CMMS system, as per procedure., • Provide on-call support during assigned weeks to ensure 24/7 coverage, • Provide practical solutions to operations/ controls problems., • Scope, estimate and execute small capital / maintenance projects along with maintenance manager/ project director/ operations, etc., • Train other employees considering their needs and company needs., • Oversee the work by contractors as required on site to ensure safe and quality performance.