Senior Technician, Filling Operations (2nd Shift) - Onsite
hace 4 días
Rahway
Job Description Note: This position is a second shift position, with hours of 3:30 PM to 12:00 AM. Positions are based in Rahway, NJ and 100 % on‑site. Pharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ Formulation Laboratory and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms. Positions will support development and clinical manufacturing and supply, as part of the FLEx‑Sterile team. This position will be responsible for hands‑on processing activities that include room setup, equipment and material preparation, equipment assembly and disassembly, cleaning, and processing of raw materials into finished drug product. These individuals are expected to partner with and support formulation development colleagues in further understanding and knowledge capture of processes, which could include providing feedback on product and process development. These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. Positions may also support commissioning, qualification and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups, including formulators, engineers, Quality, Safety and Facilities management, to drive overall success and performance of the area and clinical pipeline. Key Responsibilities Prepares, operates, and cleans equipment and facilities used in clinical development and manufacturing processes. Maintains, inventories and transports required processing equipment, materials, supplies and products. Executes all documentation and clerical functions necessary to maintain good manufacturing practice (GMP) operations, using paper‑based and electronic systems. Maintains detailed knowledge of process equipment and operations. Troubleshoots equipment/systems to resolve issues and aid in technology and process development, capturing learnings to improve systems and processes. Attends and actively participates in safety, quality and process improvement initiatives to enhance flexibility, efficiency and compliance. Supports investigations and implementation of corrective and preventative actions. Mentors and trains other team members within the department. Education Minimum Requirements High School Diploma/GED, with at least 5 years in pharmaceutical manufacturing or processing. Associates Degree in Science/Engineering related field with at least 3 years in pharmaceutical manufacturing. Bachelors Degree in Engineering Technology or related field. Required Experience and Skills Relevant GMP Pharmaceutical experience, or equivalent (e.g., chemical, nuclear, military experience). Demonstrated written and verbal communication skills. Proficiency in computer systems and applications including Microsoft Office (Word, Excel, Outlook), Equipment HMI use, SAP, Calibration/Maintenance Database Systems. Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don and wear cleanroom protective gowning including respirators. Demonstrated ability to work and communicate both independently and as part of a team. Preferred Experience and Skills Familiarity with regulatory requirements and Good Documentation Practices (GDP). Experience with highly complex and state‑of‑the‑art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, SAP or other ERP systems. BioWork Certificate (working in an FDA or similar regulated industry). Experience with automated systems (MES, SAP or similar). Demonstrated troubleshooting and problem‑solving skills. Demonstrated ability to identify and initiate process improvements. The salary range for this role is: $63,800 - $100,400. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision, and other healthcare insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. Shift: 2nd – Evening, 3:30 PM to 12:00 AM. Location: Rahway, NJ, 100 % on‑site. Employee Status: Regular. Relocation: Domestic. VISA Sponsorship: No. Travel Requirements: None. Flexible Work Arrangements: Not Applicable. Valid Driving License: No. Hazardous Material(s): n/a. Job Posting End Date: 06/23/2026. We are an Equal Employment Opportunity Employer and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC website. Our company is committed to inclusion and an equitable hiring process. If you need an accommodation during the application or hiring process, please request one. #J-18808-Ljbffr