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Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Senior Computer System Validation (CSV) Specialist - with expertise in Manufacturing Execution Systems (MES), specifically Syncade, to support a biologics manufacturing facility. The role will be responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. The candidate will work closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle. Key Responsibilities • Lead and execute CSV activities for MES (Syncade) in a biologics GMP environment., • Develop and maintain validation documentation including Validation Plans, User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, IQ/OQ/PQ protocols, and summary reports., • Partner with Manufacturing and Quality to ensure MES recipes, workflows, and master batch records are validated and compliant., • Perform impact assessments and change control for system upgrades, patches, and enhancements., • Ensure alignment of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other applicable regulations., • Collaborate with IT and Engineering teams for system integration (e.g., LIMS, ERP/SAP, DeltaV, PI Historian)., • Provide audit support during regulatory inspections (FDA, EMA, MHRA, etc.) and customer audits., • Mentor junior validation engineers and support knowledge transfer on CSV best practices., • Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field. Advanced degree preferred., • 7–10+ years of experience in Computer System Validation within GMP-regulated biologics/pharmaceutical manufacturing., • Hands-on expertise with MES Syncade validation and configuration (recipes, workflows, batch records)., • Strong knowledge of regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q7, GAMP 5., • Experience in biologics manufacturing processes (cell culture, purification, fill/finish)., • Familiarity with integration points (DCS/DeltaV, LIMS, ERP/SAP, data historians)., • Excellent technical writing and documentation skills., • Experience in large-scale biotech/biologics start-up or tech transfer projects., • Knowledge of data integrity principles and ALCOA+ requirements., • Exposure to quality management systems (TrackWise, Veeva, ValGenesis, Kneat)., • Understanding of 21st Century Cures Act and CSA (Computer Software Assurance) approaches.

Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Senior Computer System Validation (CSV) Specialist - with expertise in Manufacturing Execution Systems (MES), specifically Syncade, to support a biologics manufacturing facility. The role will be responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. The candidate will work closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle. Key Responsibilities • Lead and execute CSV activities for MES (Syncade) in a biologics GMP environment., • Develop and maintain validation documentation including Validation Plans, User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, IQ/OQ/PQ protocols, and summary reports., • Partner with Manufacturing and Quality to ensure MES recipes, workflows, and master batch records are validated and compliant., • Perform impact assessments and change control for system upgrades, patches, and enhancements., • Ensure alignment of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other applicable regulations., • Collaborate with IT and Engineering teams for system integration (e.g., LIMS, ERP/SAP, DeltaV, PI Historian)., • Provide audit support during regulatory inspections (FDA, EMA, MHRA, etc.) and customer audits., • Mentor junior validation engineers and support knowledge transfer on CSV best practices., • Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field. Advanced degree preferred., • 7–10+ years of experience in Computer System Validation within GMP-regulated biologics/pharmaceutical manufacturing., • Hands-on expertise with MES Syncade validation and configuration (recipes, workflows, batch records)., • Strong knowledge of regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q7, GAMP 5., • Experience in biologics manufacturing processes (cell culture, purification, fill/finish)., • Familiarity with integration points (DCS/DeltaV, LIMS, ERP/SAP, data historians)., • Excellent technical writing and documentation skills., • Experience in large-scale biotech/biologics start-up or tech transfer projects., • Knowledge of data integrity principles and ALCOA+ requirements., • Exposure to quality management systems (TrackWise, Veeva, ValGenesis, Kneat)., • Understanding of 21st Century Cures Act and CSA (Computer Software Assurance) approaches.

Job DescriptionCompany Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. Job Description Senior Computer System Validation (CSV) Specialist - with expertise in Manufacturing Execution Systems (MES), specifically Syncade, to support a biologics manufacturing facility. The role will be responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. The candidate will work closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle. Key Responsibilities • Lead and execute CSV activities for MES (Syncade) in a biologics GMP environment., • Develop and maintain validation documentation including Validation Plans, User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, IQ/OQ/PQ protocols, and summary reports., • Partner with Manufacturing and Quality to ensure MES recipes, workflows, and master batch records are validated and compliant., • Perform impact assessments and change control for system upgrades, patches, and enhancements., • Ensure alignment of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other applicable regulations., • Collaborate with IT and Engineering teams for system integration (e.g., LIMS, ERP/SAP, DeltaV, PI Historian)., • Provide audit support during regulatory inspections (FDA, EMA, MHRA, etc.) and customer audits., • Mentor junior validation engineers and support knowledge transfer on CSV best practices., • Contribute to continuous improvement of MES validation strategies, procedures, and templates.Qualifications Qualifications • Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field. Advanced degree preferred., • 7–10+ years of experience in Computer System Validation within GMP-regulated biologics/pharmaceutical manufacturing., • Hands-on expertise with MES Syncade validation and configuration (recipes, workflows, batch records)., • Strong knowledge of regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q7, GAMP 5., • Experience in biologics manufacturing processes (cell culture, purification, fill/finish)., • Familiarity with integration points (DCS/DeltaV, LIMS, ERP/SAP, data historians)., • Excellent technical writing and documentation skills., • Experience in large-scale biotech/biologics start-up or tech transfer projects., • Knowledge of data integrity principles and ALCOA+ requirements., • Exposure to quality management systems (TrackWise, Veeva, ValGenesis, Kneat)., • Understanding of 21st Century Cures Act and CSA (Computer Software Assurance) approaches. Additional Information All your information will be kept confidential according to EEO guidelines.

Job DescriptionCompany Description From concept to design to execution, be part of the team that gets everyday products to people. Do you want to have an impact on creating products from today’s top brands? Does having a company care about your career today and into the future motivate you? Does an environment where your opinions matter excite you? Are you a natural born tinkerer? If so, you have found your next calling!! Grantek is a recognized leading provider of integrated automation, smart manufacturing and industrial information solutions in the global marketplace. Our clients are some of the worlds most respected Fortune 100 companies and recognized consumer brands. We offer an atmosphere where you can express your creative ideas and talents by working on a variety of projects and technologies. Using today’s leading edge technology, you will partner with clients to solve their most complex manufacturing and industrial information problems. We offer a competitive and comprehensive compensation package, retirement matching, company paid benefits, flexible work hours, and an education/career development program. For more information on what Grantek offers, visit: We are committed to providing a positive and healthy corporate culture, one that empowers employees, promotes knowledge-sharing, and encourages strong friendships and social connections amongst all team members. We are a team of dedicated Engineers and Designers with an average of 7 years’ tenure at Grantek. The vast majority of our employees have started off their careers at Grantek and have grown into successful senior team members who are integral to our client's manufacturing processes. Job Description We are seeking a highly skilled and experienced Systems Engineer, preferably with experience in food and beverage and life sciences industries. As a key member of Grantek’s Engineering team, you will be developing real-time automation solutions from the manufacturing plant floor to the enterprise level, using a variety of programming, configuration, and design tools: PLC and PAC Programming, Operator Interface and HMI application design, SCADA design, Network design, Database design, Vision system design, and more. Key-skills and interests: machine and process control, information solutions, database development, operational efficiency, mechatronics. Primary Job Responsibilities • Engineering and implementing real-time automation controls and information solutions., • Conceptualizing during the design phase of the project life cycle., • System programming, debugging, and testing., • Creating documentation, including project engineering notes, project proposals, project design traceability documentation, case studies, and more., • Commissioning new solutions at client sites; finding opportunities for improvements., • Creating methodologies and complex problem-solving., • Learning new technologies., • Mentoring colleagues on your expertise and knowledge base., • Having fun and being challenged. Technologies Used • PLC Programming Platforms: Rockwell / Allen-Bradley, Siemens, Omron, Modicon, GE, etc., • HMI Platforms: Rockwell / Allen-Bradley, Wonderware, Schneider Electric, etc., • SCADA Platforms: Rockwell / Allen-Bradley, Inductive Automation, Wonderware, GE, Siemens, etc., • System Networking: Ethernet, Routing and Switching, EthernetIP, Profibus. Experience in DeviceNet, ControlNet, DH+, Remote IO, Modbus, etc is preferred but not necessary., • Vision Platforms: Cognex, Datalogic, Keyence, etc., • Experience with Python, Historian (PI System), and databases is a plus, • Project Documentation: Microsoft Office.Qualifications, • Successful or upcoming completion of B.Sc. Computer Engineering, Mechatronics, Computer Science, Electrical Engineering, or related Engineering Technology degree., • At least 3-5 years of working experience with some or all the listed “Technologies Used”, in previous section., • Meticulous, conscientious, analytical, focused, self-starter individual, who is a quick learner., • Excellent communication skills – both verbal and written., • Valid Driver’s License., • Have full-time access to a personal vehicle., • Willingness to travel up to 30-50% within USA. Additional Information We are committed to the principle of equal employment opportunity for all employees and to provide Grantekians with a work environment free of discrimination and harassment.

Job Description Senior MES Engineer Raleigh, NC If you post this job on a job board, please do not use company name or salary. Experience level: Mid-senior Experience required: 10 Years Education level: Bachelors degree Job function: Engineering Industry: Industrial Automation Compensation: View salary Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No JOB DESCRIPTION: This position requires demonstrated technical proficiency in software design and configuration of MES solutions with integration capabilities to level two and four systems. The Senior MES Engineer will interact directly with the customer and lead a team of Wunderlich-Malec engineers in identifying requirements, evaluating MES platforms, developing specifications, and implementing/testing/commissioning/qualifying MES solutions. This position is a leadership role within the business unit and requires strong problem-solving ability, well-balanced people skills, an aptitude for business efficiency, and an interest in creating partnerships. The Senior MES Engineer demonstrates success by securing repeat work with both new and existing customers. RESPONSIBILITIES: This position requires the ability to deliver innovative MES solutions and design standards either self-directedly or as a leader of a team. The candidate will act as a solution architect and must have the ability to conceptualize, detail, and implement MES Solutions for industrial processes and machinery that meet our customers requirements. This involves the development of an MES strategy that integrates process knowledge, equipment design, and quality standards with information technology to reduce downtime, elevate the level of regulatory compliance, and introduce efficiency gains through the effective use of available technologies. This position oftentimes requires the following project management responsibilities: developing project execution plans, work breakdown structures, and associated budgets, task prioritization and scheduling, task ordering, time tracking, and reporting, financial tracking and reporting, early problem identification, conflict management/resolution, leading and supporting a team, and attending project status meetings. Also includes overseeing daily operations and activities of a project(s) up to $1M. This position is often responsible for ensuring the overall profitability of the project. The ideal candidate must have a diverse engineering skillset with the ability to work independently. Will act as technical lead on projects and guide lower-level engineers and technicians. Could also act as Project Manager on smaller projects. QUALIFICATIONS: Education: A Bachelor of Science degree in Engineering, Computer Science or the Applied Sciences required. Experience Greater than 10 years with capabilities in the below areas is preferred: MES solution deployment experience with but not limited to Werum PAS-X, Sepasoft, or POMS Proven experience with all phases of MES projects including conceptual, basis of design, implementation, testing, start-up, and commissioning in the Life Science industry Familiarity with relevant regulatory requirements of the life science industry such as cGMP, 21 CFR Part 11, etc. Demonstrated proficiency with designing and implementing integrated EBR recipes using GAMP5, S88, and S95 standards Understand the manufacturing processes and system configuration and make informed recommendations regarding optimal system configuration Understanding of warehouse and inventory management specifically in a GMP facility Support software and configuration required for external systems interfaces such as DeltaV, SAP, LIMS, PI, and Maximo Strong knowledge of historian technology and reporting systems Experience with relational databases such as SQL, Oracle, etc. Strong knowledge of IT/OT networking Excellent technical writing and verbal communication skills Working knowledge of MS Office products Experience leading a team of engineers/technicians to provide MES solutions Experience mentoring less experienced engineers Professional references, preferably one from each of the following: a subordinate, a peer, and a manager Ability to travel up to 25% PHYSICAL DEMANDS OF POSITION: Seeing, color perception, hearing, clear speech, dexterity in hands, driving, lifting, ability to mount/dismount equipment, pushing and pulling. WORKING ENVIRONMENT: Standard office environment, on-site office environment, diverse industrial environments, frequent use of a personal computer, facsimile/copy machines, and phones. About Wunderlich-Malec: As a 100% Employee-Owned Company our people are passionate about solving your unique engineering challenges, and with the support of industry experts behind them, they can successfully execute projects of any size while meeting your requirements of scope, schedule, and budget. Wunderlich-Malec has been providing customers with engineering, system integration and fabrication solutions for more than 40 years. With offices throughout the US and over 500 professionals on our staff, we are one of the largest and most well-established engineering companies in the United States, and we've successfully finished numerous projects for our US clients in many parts of the world. We're confident that our qualified staff has the knowledge, experience, and talent to create and deliver the solutions you need for your facility process and operation needs. Wunderlich-Malec ranks on Inc. 5000's Fastest-Growing Private Companies list and is a GSA Schedule holder with the Federal Government for professional engineering services and manufacturing.

Job Description JOB DESCRIPTION: • This position requires demonstrated technical proficiency in software design and configuration of MES solutions with integration capabilities to level two and four systems., • The Senior MES Engineer will interact directly with the customer and lead a team of Wunderlich-Malec engineers in identifying requirements, evaluating MES platforms, developing specifications, and implementing/testing/commissioning/qualifying MES solutions., • This position is a leadership role within the business unit and requires strong problem-solving ability, well-balanced people skills, an aptitude for business efficiency, and an interest in creating partnerships., • This position requires the ability to deliver innovative MES solutions and design standards either self-directedly or as a leader of a team. The candidate will act as a solution architect and must have the ability to conceptualize, detail, and implement MES Solutions for industrial processes and machinery that meet our customers’ requirements. This involves the development of an MES strategy that integrates process knowledge, equipment design, and quality standards with information technology to reduce downtime, elevate the level of regulatory compliance, and introduce efficiency gains through the effective use of available technologies., • This position oftentimes requires the following project management responsibilities: developing project execution plans, work breakdown structures, and associated budgets, task prioritization and scheduling, task ordering, time tracking, and reporting, financial tracking and reporting, early problem identification, conflict management/resolution, leading and supporting a team, and attending project status meetings. Also includes overseeing daily operations and activities of a project(s) up to $1M. This position is often responsible for ensuring the overall profitability of the project., • Education: A Bachelor of Science degree in Engineering, Computer Science or the Applied Sciences required., • Experience – Greater than 10 years with capabilities in the below areas is preferred:, • MES solution deployment experience with but not limited to Werum PAS-X, Sepasoft, or POMS, • Proven experience with all phases of MES projects including conceptual, basis of design, implementation, testing, start-up, and commissioning in the Life Science industry, • Familiarity with relevant regulatory requirements of the life science industry such as cGMP, 21 CFR Part 11, etc., • Demonstrated proficiency with designing and implementing integrated EBR recipes using GAMP5, S88, and S95 standards, • Understand the manufacturing processes and system configuration and make informed recommendations regarding optimal system configuration, • Understanding of warehouse and inventory management specifically in a GMP facility, • Support software and configuration required for external systems interfaces such as DeltaV, SAP, LIMS, PI, and Maximo, • Strong knowledge of historian technology and reporting systems, • Experience with relational databases such as SQL, Oracle, etc., • Strong knowledge of IT/OT networking, • Excellent technical writing and verbal communication skills, • Working knowledge of MS Office products, • Experience leading a team of engineers/technicians to provide MES solutions, • Experience mentoring less experienced engineers, • Professional references, preferably one from each of the following: a subordinate, a peer, and a manager by9UJrqno0

Job Description Qualified candidates must have demonstrable skills in planning and conducting work requiring judgment regarding the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Successfully completes small to medium engineering projects by organizing and controlling project elements. Purpose: Acropolis is looking for a dedicated, qualified senior technical manager to support our current clients. If you like to work within a small, focused, team-supported project environment, then this could be the perfect job for you! Duties: Lead controls projects and process applications. Additional duties may include the following: • Must have a strong understanding of ISA-88 Batch Control applications and modular concepts., • Strong understanding of cGMP practices and GAMP5 is a must., • Strong understanding on Computer System Validation and computer system life cycle management is a must., • Strong capital project experience is a must., • Write project specifications, equipment, and instrument data sheets., • Develop functional specifications and flow diagrams., • Provide simulation support for chemical and manufacturing processes., • Support development of automation, control, and historian solutions for clients., • Provide technical direction to mid-level and junior-level staff., • Provide technical review of progress by site selected vendors., • Update schedules and task lists., • Provide direction for personnel performing in-field troubleshooting, process startups for new or modified production equipment., • Provide expertise in DeltaV Operate and Live., • Provide expertise with PLC architecture design, programming, testing, and validation., • Lead client through the development process., • Author and review URS, FRS, and SDS documents., • Support FATs and SATs., • Support CQV and CSV activities., • Follow established procedures per job scope, and specific design guidelines relative to the project., • CFR Part 11 Compliance experience., • Experience with Upstream and Downstream manufacturing processes and equipment., • Create and manage overall system design., • Assure project compliance with Code, Standards, and URS., • Perform design calculations, equipment selections, and review calculations performed by the project designer., • Perform existing system and equipment evaluations., • Coordinate with Instrument and Controls Engineer and establish parameters for automation., • Support the development of Process Descriptions with the client., • Provide direction to project staff, and maintain project schedules, timelines, and budgets., • Mentor junior designers to develop them into experienced engineers., • Support, and at times lead RFP responses, proposal writing, and client presentations, and actively contribute to client relationship management., • Stay abreast of state-of-the-art design through independent reading, attendance of seminars, and continuing education. Participate in design, analysis, and documentation training as listed in the Discipline Training guidelines, • Bachelor of Science in Chemical Engineering, Mechanical Engineering, or related discipline., • 10-15+ years’ experience in manufacturing, and or chemical process design., • Expertise in preparation of construction documents for large, technically sophisticated projects., • Application knowledge of cybersecurity concepts to automation designs., • Knowledge of engineering calculations and equipment selection programs., • Demonstrated ability in Process Simulation. · Piping & Instrumentation (P&ID) interpretation. · Knowledge of automation systems. · Proficient at Control System Design. · Ability to plan, engineer, and execute from start to finish. · Platform experience with DeltaV DCS. · Platform experience with Siemens TIA Portal v14/v15. · Platform experience with Rockwell Automation software, e.g., RSLogix 5000, Factory Talk Machine Edition/Site Edition, Factory Talk View, etc., highly preferred. · Knowledge of validation strategies and test case development. · Ability to work safely and efficiently in a fast-paced team-oriented environment. · Capacity to handle multiple tasks, have excellent attention to detail and be willing and able to learn new technologies quickly. · Experience performing electrical maintenance on industrial machinery in a manufacturing environment. · Knowledge of electrical safety standards. · Interested in pursuing project management responsibilities. · Professional demeanor and communication skills is a must. · Understanding of process utilities, HVAC, and manufacturing is a plus. Physical Requirements: · Requires constant standing and moving 8-12 hours per day. · Must be able to lift and carry up to 75 lbs. · Must be able to bend, stoop, squat and kneel. · Must be able to push and pull up to 15 lbs. · Must be able to reach overhead. We offer: · Training opportunities. · Health Insurance – major medical, dental and vision. · Paid holidays, vacation, and personal time. Company DescriptionWe are a growing industrial automation and data management solution provider to the biopharma industry in North Carolina, seeking a motivated, senior-level (10–15 years) Senior Technical Manager. This position will require time spent on-site, directly engaging with clients, and WFH days. As such, we hire the best and brightest with a focus on building lasting relationships with customers, partners, independent consultants and our employees. From our Raleigh-based beginnings in 2014, we are building our company while serving Fortune 500 companies in the southeast. This is an opportunity to grow, see the change, and make great things happen. Acropolis Engineers is an equal opportunity employer, and we value diversity at our company. All qualified applicants will receive consideration for employment or contract opportunities without regard to race, color, national origin, religion, sex, pregnancy, gender expression, gender identity, age, sexual orientation, genetic information, status as an individual with a disability, or status as a protected veteran.We are a growing industrial automation and data management solution provider to the biopharma industry in North Carolina, seeking a motivated, senior-level (10–15 years) Senior Technical Manager. This position will require time spent on-site, directly engaging with clients, and WFH days.\r\n\r\nAs such, we hire the best and brightest with a focus on building lasting relationships with customers, partners, independent consultants and our employees. From our Raleigh-based beginnings in 2014, we are building our company while serving Fortune 500 companies in the southeast. This is an opportunity to grow, see the change, and make great things happen.\r\n\r\nAcropolis Engineers is an equal opportunity employer, and we value diversity at our company. All qualified applicants will receive consideration for employment or contract opportunities without regard to race, color, national origin, religion, sex, pregnancy, gender expression, gender identity, age, sexual orientation, genetic information, status as an individual with a disability, or status as a protected veteran.

Job Description JOB DESCRIPTION: • We have a Senior DeltaV Engineer opportunity in our Raleigh, NC office., • This person will lead the design, implementation, and project management of large-scale capital automation projects within the Life Sciences industry., • This role requires proficiency with Emerson DeltaV systems and a strong technical background in designing and delivering cGMP-compliant automation solutions., • All areas of responsibility listed below are essential to the satisfactory performance of this position, with reasonable accommodation, if necessary., • Design and implement DeltaV control systems for complex Life Sciences capital projects, • Develop and manage project schedules, budgets, and resources, ensuring on-time and within-budget project execution, • Lead system architecture development and control strategies to enhance manufacturing efficiency, • Design batch sequencing, phase logic, and recipe structures to optimize production efficiency and regulatory compliance, • Develop DeltaV graphics using DeltaV Live and DeltaV Operate in alignment with ISA-101 HMI guidelines, • Utilize a class-based approach in overall design to maximize scalability and standardization across projects, • Develop electrical designs, including power distribution, panel layouts, and grounding strategies for automation systems, • Specify and procure instrumentation and hardware components, • Design and implement industrial networking solutions, including Ethernet/IP, Modbus TCP/IP, Profibus, and Foundation Fieldbus, • Integrate 3rd party equipment with DeltaV systems using protocols such as OPC UA, Ethernet/IP, and Modbus, • Define computing infrastructure requirements, including server architecture, virtualization, cybersecurity, and redundancy planning, • Design, plan, and specify DeltaV system licensing based on user requirements and project scope to ensure cost-effective and scalable solutions, • Oversee the full project lifecycle, from requirements gathering to commissioning and validation, • Ensure project deliveries and execution methodology compliance with GAMP5, cGMP, 21 CFR Part 11, and industry best practices, • Develop acceptance protocols and manage the execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to validate system performance, • Mentor and provide technical leadership to junior engineers and cross-disciplinary teams, • Coordinate with clients, stakeholders, and regulatory bodies to ensure project success, • Implement advanced automation strategies, including ISA-88 batch processing, historian integration, and alarm management, • Troubleshoot complex automation challenges and drive continuous improvements in system performance, • Professional degree in Electrical Engineering, Control Systems Engineering, Chemical Engineering, or a related field, • Minimum of 8-15 years in automation and control system engineering, with a strong focus on Life Sciences projects, • 8-15 years of hands-on experience with Emerson DeltaV systems, focusing on system design and project execution, • Proficiency in DeltaV Live and DeltaV Operate, including experience designing high-performance HMIs and operator interfaces, • Expertise in ISA-101 HMI design principles and high-performance graphic design strategies, • Strong experience in class-based configuration and design, • Expertise in ISA-88 batch processing, historian solutions, and advanced control strategies, • Proven experience managing large-scale capital projects in the Life Sciences industry, • Strong knowledge of automation protocols (HART, Foundation Fieldbus, Profibus, Modbus TCP/IP, Ethernet/IP, OPC UA, IO-Link), • Deep understanding of industrial networking for communication between controllers, servers, and HMIs, • Strong knowledge of cGMP, GAMP5, and regulatory compliance for biopharmaceutical manufacturing, • Experience integrating electrical and process control systems, • Strong leadership, organizational, and communication skills for cross-functional collaboration, • Experience specifying and designing electrical components, including MCCs, VFDs, control panels, and power distribution systems, • Knowledge of server infrastructure and virtualization technologies for robust DeltaV system deployment, • Extensive experience designing and implementing batch control systems within regulated Life Sciences environments, • Experience in OEM system integration using OPC UA, Ethernet/IP, and other industrial communication protocols, • Ability to plan, specify, and manage DeltaV system licensing to optimize project implementation, • The work environment characteristics described here represent those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions., • Office Work:, • Office desk/cubicle environment, • Occasional lifting, climbing, and working in production facilities during commissioning activities, • Empowered Individuals& – Employee-owned, we are able to hire the best and empower them to develop and deliver solutions, • Rewarded Motivated& – Investing in continuing education and world-class benefits keeps our staff motivated, • Positive Attitudes& – Dedicated experts are committed in the long run and bring a positive, can-do attitude to your project

Job Description JOB DESCRIPTION: • We have a Senior DeltaV Engineer opportunity in our Raleigh, NC office., • This person will lead the design, implementation, and project management of large-scale capital automation projects within the Life Sciences industry., • This role requires proficiency with Emerson DeltaV systems and a strong technical background in designing and delivering cGMP-compliant automation solutions., • All areas of responsibility listed below are essential to the satisfactory performance of this position, with reasonable accommodation, if necessary., • Design and implement DeltaV control systems for complex Life Sciences capital projects, • Develop and manage project schedules, budgets, and resources, ensuring on-time and within-budget project execution, • Lead system architecture development and control strategies to enhance manufacturing efficiency, • Design batch sequencing, phase logic, and recipe structures to optimize production efficiency and regulatory compliance, • Develop DeltaV graphics using DeltaV Live and DeltaV Operate in alignment with ISA-101 HMI guidelines, • Utilize a class-based approach in overall design to maximize scalability and standardization across projects, • Develop electrical designs, including power distribution, panel layouts, and grounding strategies for automation systems, • Specify and procure instrumentation and hardware components, • Design and implement industrial networking solutions, including Ethernet/IP, Modbus TCP/IP, Profibus, and Foundation Fieldbus, • Integrate 3rd party equipment with DeltaV systems using protocols such as OPC UA, Ethernet/IP, and Modbus, • Define computing infrastructure requirements, including server architecture, virtualization, cybersecurity, and redundancy planning, • Design, plan, and specify DeltaV system licensing based on user requirements and project scope to ensure cost-effective and scalable solutions, • Oversee the full project lifecycle, from requirements gathering to commissioning and validation, • Ensure project deliveries and execution methodology compliance with GAMP5, cGMP, 21 CFR Part 11, and industry best practices, • Develop acceptance protocols and manage the execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to validate system performance, • Mentor and provide technical leadership to junior engineers and cross-disciplinary teams, • Coordinate with clients, stakeholders, and regulatory bodies to ensure project success, • Implement advanced automation strategies, including ISA-88 batch processing, historian integration, and alarm management, • Troubleshoot complex automation challenges and drive continuous improvements in system performance, • Professional degree in Electrical Engineering, Control Systems Engineering, Chemical Engineering, or a related field, • Minimum of 8-15 years in automation and control system engineering, with a strong focus on Life Sciences projects, • 8-15 years of hands-on experience with Emerson DeltaV systems, focusing on system design and project execution, • Proficiency in DeltaV Live and DeltaV Operate, including experience designing high-performance HMIs and operator interfaces, • Expertise in ISA-101 HMI design principles and high-performance graphic design strategies, • Strong experience in class-based configuration and design, • Expertise in ISA-88 batch processing, historian solutions, and advanced control strategies, • Proven experience managing large-scale capital projects in the Life Sciences industry, • Strong knowledge of automation protocols (HART, Foundation Fieldbus, Profibus, Modbus TCP/IP, Ethernet/IP, OPC UA, IO-Link), • Deep understanding of industrial networking for communication between controllers, servers, and HMIs, • Strong knowledge of cGMP, GAMP5, and regulatory compliance for biopharmaceutical manufacturing, • Experience integrating electrical and process control systems, • Strong leadership, organizational, and communication skills for cross-functional collaboration, • Experience specifying and designing electrical components, including MCCs, VFDs, control panels, and power distribution systems, • Knowledge of server infrastructure and virtualization technologies for robust DeltaV system deployment, • Extensive experience designing and implementing batch control systems within regulated Life Sciences environments, • Experience in OEM system integration using OPC UA, Ethernet/IP, and other industrial communication protocols, • Ability to plan, specify, and manage DeltaV system licensing to optimize project implementation, • The work environment characteristics described here represent those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions., • Office Work:, • Office desk/cubicle environment, • Occasional lifting, climbing, and working in production facilities during commissioning activities, • Work may include working weekends, holidays, nightshift, and extended hours to meet deadlines and client requirements.

Job Description The company is seeking a Senior MES Engineer to join our growing Life Sciences team in North Carolina. This is a leadership role where you'll serve as both a Solution Architect and Technical Lead, guiding teams in delivering world-class MES (Manufacturing Execution System) solutions for pharmaceutical and biotech clients. Key Responsibilities: • Architect, configure, test, and commission MES solutions in regulated Life Sciences environments, • Deliver end-to-end MES projects: conceptual design, implementation, validation, start-up, and commissioning, • Develop strategies that reduce downtime, increase compliance, and improve efficiency, • Lead and mentor engineers/technicians, providing technical oversight and guidance, • Support business development by engaging with clients, presenting at conferences, and building long-term relationships, • Manage project execution plans, budgets, and schedules, and ensure overall project profitabilityMust-Have Qualifications:, • Bachelor's degree in Engineering, Computer Science, or Applied Sciences, • 10+ years of MES experience; minimum 4 years in Life Sciences MES, • Proven expertise in deploying Werum PAS-X, Sepasoft, or POMS, • Strong knowledge of cGMP, 21 CFR Part 11, S88, S95, GAMP5, • Hands-on experience with EBR recipe design, warehouse & inventory management, and regulatory compliance, • Skilled in integrating MES with external systems (DeltaV, SAP, LIMS, PI, Maximo), • Experience with SQL/Oracle databases, historian technologies, and IT/OT networking, • Excellent leadership, communication, and technical writing skills, • Proven ability to bring in new business and represent at trade shows/industry events

Job Description JOB DESCRIPTION: • This position requires demonstrated technical proficiency in software design and configuration of MES solutions with integration capabilities to level two and four systems., • The Senior MES Engineer will interact directly with the customer and lead a team of Wunderlich-Malec engineers in identifying requirements, evaluating MES platforms, developing specifications, and implementing/testing/commissioning/qualifying MES solutions., • This position is a leadership role within the business unit and requires strong problem-solving ability, well-balanced people skills, an aptitude for business efficiency, and an interest in creating partnerships., • This position requires the ability to deliver innovative MES solutions and design standards either self-directedly or as a leader of a team. The candidate will act as a solution architect and must have the ability to conceptualize, detail, and implement MES Solutions for industrial processes and machinery that meet our customers requirements. This involves the development of an MES strategy that integrates process knowledge, equipment design, and quality standards with information technology to reduce downtime, elevate the level of regulatory compliance, and introduce efficiency gains through the effective use of available technologies., • This position oftentimes requires the following project management responsibilities: developing project execution plans, work breakdown structures, and associated budgets, task prioritization and scheduling, task ordering, time tracking, and reporting, financial tracking and reporting, early problem identification, conflict management/resolution, leading and supporting a team, and attending project status meetings. Also includes overseeing daily operations and activities of a project(s) up to $1M. This position is often responsible for ensuring the overall profitability of the project., • Education: A Bachelor of Science degree in Engineering, Computer Science or the Applied Sciences required., • Experience Greater than 10 years with capabilities in the below areas is preferred:, • MES solution deployment experience with but not limited to Werum PAS-X, Sepasoft, or POMS, • Proven experience with all phases of MES projects including conceptual, basis of design, implementation, testing, start-up, and commissioning in the Life Science industry, • Familiarity with relevant regulatory requirements of the life science industry such as cGMP, 21 CFR Part 11, etc., • Demonstrated proficiency with designing and implementing integrated EBR recipes using GAMP5, S88, and S95 standards, • Understand the manufacturing processes and system configuration and make informed recommendations regarding optimal system configuration, • Understanding of warehouse and inventory management specifically in a GMP facility, • Support software and configuration required for external systems interfaces such as DeltaV, SAP, LIMS, PI, and Maximo, • Strong knowledge of historian technology and reporting systems, • Experience with relational databases such as SQL, Oracle, etc., • Strong knowledge of IT/OT networking, • Excellent technical writing and verbal communication skills, • Working knowledge of MS Office products, • Experience leading a team of engineers/technicians to provide MES solutions, • Experience mentoring less experienced engineers, • Professional references, preferably one from each of the following: a subordinate, a peer, and a manager, • Seeing, color perception, hearing, clear speech, dexterity in hands, driving, lifting, ability to mount/dismount equipment, pushing and pulling.

Job Description With over 40 successful years in business and having over 35 facilities across the USA this engineering firm has been named on the ENR Top 500 Design Firm list and has continued to climb in rank over the years. In addition, they have been named as a certified integrator by many vendors as they do not focus on just one platform, but their engineers will work with the customer choose the best platform for each application. With over 600 employees nationwide they have become one of the largest and established firms in the United States. Ideally you will come into the office throughout the week and work onsite, although hybrid is possible, must live in commutable distance to Raleigh, NC. Reasons to work for this company: • Opportunity to get involved with challenging projects across many different industries, • They offer comprehensive medical/dental insurance, • Profit Sharing/401K match and Employee Stock Ownership Plan Essential Duties and Responsibilities: All areas of responsibility listed below are essential to the satisfactory performance of this position, with reasonable accommodation, if necessary. • Design and implement DeltaV control systems for complex Life Sciences capital projects, • Develop and manage project schedules, budgets, and resources, ensuring on-time and within-budget project execution, • Lead system architecture development and control strategies to enhance manufacturing efficiency, • Design batch sequencing, phase logic, and recipe structures to optimize production efficiency and regulatory compliance, • Develop DeltaV graphics using DeltaV Live and DeltaV Operate in alignment with ISA-101 HMI guidelines, • Utilize a class-based approach in overall design to maximize scalability and standardization across projects, • Develop electrical designs, including power distribution, panel layouts, and grounding strategies for automation systems, • Specify and procure instrumentation and hardware components, • Design and implement industrial networking solutions, including Ethernet/IP, Modbus TCP/IP, Profibus, and Foundation Fieldbus, • Integrate 3rd party equipment with DeltaV systems using protocols such as OPC UA, Ethernet/IP, and Modbus, • Define computing infrastructure requirements, including server architecture, virtualization, cybersecurity, and redundancy planning, • Design, plan, and specify DeltaV system licensing based on user requirements and project scope to ensure cost-effective and scalable solutions, • Oversee the full project lifecycle, from requirements gathering to commissioning and validation, • Ensure project deliveries and execution methodology compliance with GAMP5, cGMP, 21 CFR Part 11, and industry best practices, • Develop acceptance protocols and manage the execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to validate system performance, • Mentor and provide technical leadership to junior engineers and cross-disciplinary teams, • Coordinate with clients, stakeholders, and regulatory bodies to ensure project success, • Implement advanced automation strategies, including ISA-88 batch processing, historian integration, and alarm management, • Troubleshoot complex automation challenges and drive continuous improvements in system performance, • 8+ years of hands-on experience with Emerson DeltaV systems, focusing on system design and project execution, • Proficiency in DeltaV Live and DeltaV Operate, including experience designing high-performance HMIs and operator interfaces, • Expertise in ISA-101 HMI design principles and high-performance graphic design strategies, • Strong experience in class-based configuration and design, • Expertise in ISA-88 batch processing, historian solutions, and advanced control strategies, • Proven experience managing large-scale capital projects in the Life Sciences industry, • Strong knowledge of automation protocols (HART, Foundation Fieldbus, Profibus, Modbus TCP/IP, Ethernet/IP, OPC UA, IO-Link), • Deep understanding of industrial networking for communication between controllers, servers, and HMIs, • Strong knowledge of cGMP, GAMP5, and regulatory compliance for biopharmaceutical manufacturing, • Experience integrating electrical and process control systems, • Strong leadership, organizational, and communication skills for cross-functional collaboration, • Experience specifying and designing electrical components, including MCCs, VFDs, control panels, and power distribution systems, • Knowledge of server infrastructure and virtualization technologies for robust DeltaV system deployment, • Extensive experience designing and implementing batch control systems within regulated Life Sciences environments, • Experience in OEM system integration using OPC UA, Ethernet/IP, and other industrial communication protocols, • Ability to plan, specify, and manage DeltaV system licensing to optimize project implementation

Job Description Position: Senior MES Engineer Location: Raleigh, NC On-site Employment Type: Full-time | Mid-Senior Level Industry: Industrial Automation Experience Required: 8- 10+ years in MES (at least 4 years in Life-Science MES) Education: Bachelors degree in Engineering, Computer Science, or Applied Sciences Relocation: No Visa Sponsorship: Not eligible Role Overview We are seeking a Senior MES Engineer with strong expertise in MES solution design and configuration and integration to Level 2 & 4 systems. The role requires direct interaction with customers, leading teams, and delivering end-to-end MES solutions. This is a leadership position that combines technical depth, project delivery, and the ability to guide junior engineers while supporting business development activities. Key Responsibilities • Act as Solution Architect for conceptualizing, detailing, and implementing MES solutions for industrial processes and machinery., • Lead the full lifecycle of MES projects: concept, design, implementation, testing, start-up, commissioning, qualification (Life-Science industry)., • Integrate PLC/DCS, historian technology, reporting systems, relational databases, ERP systems., • Ensure compliance with cGMP, 21 CFR Part 11, and related Life-Science regulatory requirements., • Mentor and guide engineers/technicians; may serve as Project Manager for smaller projects., • Based in North Carolina, willing to travel up to 25%., • 8 - 10+ years total MES experience with 4+ years in Life-Science MES., • Hands-on experience with Werum PAS-X, Sepasoft, or POMS., • Proven System Architect experience in greenfield and brownfield MES deployments., • Familiarity with GAMP5, S88, S95 standards and EBR recipe design., • Strong understanding of IT/OT networking, historian technology, reporting systems, SQL/Oracle databases.

Job Description JOB DESCRIPTION: • We have a Senior DeltaV Engineer opportunity in our Raleigh, NC office., • This person will lead the design, implementation, and project management of large-scale capital automation projects within the Life Sciences industry., • This role requires proficiency with Emerson DeltaV systems and a strong technical background in designing and delivering cGMP-compliant automation solutions., • All areas of responsibility listed below are essential to the satisfactory performance of this position, with reasonable accommodation, if necessary., • Design and implement DeltaV control systems for complex Life Sciences capital projects, • Develop and manage project schedules, budgets, and resources, ensuring on-time and within-budget project execution, • Lead system architecture development and control strategies to enhance manufacturing efficiency, • Design batch sequencing, phase logic, and recipe structures to optimize production efficiency and regulatory compliance, • Develop DeltaV graphics using DeltaV Live and DeltaV Operate in alignment with ISA-101 HMI guidelines, • Utilize a class-based approach in overall design to maximize scalability and standardization across projects, • Develop electrical designs, including power distribution, panel layouts, and grounding strategies for automation systems, • Specify and procure instrumentation and hardware components, • Design and implement industrial networking solutions, including Ethernet/IP, Modbus TCP/IP, Profibus, and Foundation Fieldbus, • Integrate 3rd party equipment with DeltaV systems using protocols such as OPC UA, Ethernet/IP, and Modbus, • Define computing infrastructure requirements, including server architecture, virtualization, cybersecurity, and redundancy planning, • Design, plan, and specify DeltaV system licensing based on user requirements and project scope to ensure cost-effective and scalable solutions, • Oversee the full project lifecycle, from requirements gathering to commissioning and validation, • Ensure project deliveries and execution methodology compliance with GAMP5, cGMP, 21 CFR Part 11, and industry best practices, • Develop acceptance protocols and manage the execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to validate system performance, • Mentor and provide technical leadership to junior engineers and cross-disciplinary teams, • Coordinate with clients, stakeholders, and regulatory bodies to ensure project success, • Implement advanced automation strategies, including ISA-88 batch processing, historian integration, and alarm management, • Troubleshoot complex automation challenges and drive continuous improvements in system performance, • Professional degree in Electrical Engineering, Control Systems Engineering, Chemical Engineering, or a related field, • Minimum of 8-15 years in automation and control system engineering, with a strong focus on Life Sciences projects, • 8-15 years of hands-on experience with Emerson DeltaV systems, focusing on system design and project execution, • Proficiency in DeltaV Live and DeltaV Operate, including experience designing high-performance HMIs and operator interfaces, • Expertise in ISA-101 HMI design principles and high-performance graphic design strategies, • Strong experience in class-based configuration and design, • Expertise in ISA-88 batch processing, historian solutions, and advanced control strategies, • Proven experience managing large-scale capital projects in the Life Sciences industry, • Strong knowledge of automation protocols (HART, Foundation Fieldbus, Profibus, Modbus TCP/IP, Ethernet/IP, OPC UA, IO-Link), • Deep understanding of industrial networking for communication between controllers, servers, and HMIs, • Strong knowledge of cGMP, GAMP5, and regulatory compliance for biopharmaceutical manufacturing, • Experience integrating electrical and process control systems, • Strong leadership, organizational, and communication skills for cross-functional collaboration, • Experience specifying and designing electrical components, including MCCs, VFDs, control panels, and power distribution systems, • Knowledge of server infrastructure and virtualization technologies for robust DeltaV system deployment, • Extensive experience designing and implementing batch control systems within regulated Life Sciences environments, • Experience in OEM system integration using OPC UA, Ethernet/IP, and other industrial communication protocols, • Ability to plan, specify, and manage DeltaV system licensing to optimize project implementation, • Knowledge of Rockwell Automation, Inductive Automation Ignition, Siemens PCS7, or other DCS/SCADA systems is a plusCompany DescriptionWe are Job1USA, a Human Resource Company. We are a leading provider of contract staffing, contract security, direct hire services, and total solutions. Integrity, reliability, and operational excellence are hallmarks of our service to our customers. As a national class provider of human resources, we are first and foremost a people company. We believe in the diversity of our workforce and in the dignity of the individual. We are committed to the respect and safety of our employees.We are Job1USA, a Human Resource Company. We are a leading provider of contract staffing, contract security, direct hire services, and total solutions. Integrity, reliability, and operational excellence are hallmarks of our service to our customers.\r\n\r\nAs a national class provider of human resources, we are first and foremost a people company. We believe in the diversity of our workforce and in the dignity of the individual. We are committed to the respect and safety of our employees.

• We have a Senior DeltaV Engineer opportunity in our Raleigh, NC office., • This person will lead the design, implementation, and project management of large-scale capital automation projects within the Life Sciences industry., • This role requires proficiency with Emerson DeltaV systems and a strong technical background in designing and delivering cGMP-compliant automation solutions., • The ideal candidate will have a proven track record of managing complete project life cycles, ensuring compliance with industry regulations, and collaborating with cross-functional teams to optimize biopharmaceutical and medical device manufacturing processes. QUALIFICATIONS: • Professional degree in Electrical Engineering, Control Systems Engineering, Chemical Engineering, or a related field, • Minimum of 8-15 years in automation and control system engineering, with a strong focus on Life Sciences projects, • 8-15 years of hands-on experience with Emerson DeltaV systems, focusing on system design and project execution, • Proficiency in DeltaV Live and DeltaV Operate, including experience designing high-performance HMIs and operator interfaces, • Expertise in ISA-101 HMI design principles and high-performance graphic design strategies, • Strong experience in class-based configuration and design, • Expertise in ISA-88 batch processing, historian solutions, and advanced control strategies, • Proven experience managing large-scale capital projects in the Life Sciences industry, • Strong knowledge of automation protocols (HART, Foundation Fieldbus, Profibus, Modbus TCP/IP, Ethernet/IP, OPC UA, IO-Link), • Deep understanding of industrial networking for communication between controllers, servers, and HMIs, • Strong knowledge of cGMP, GAMP5, and regulatory compliance for biopharmaceutical manufacturing, • Experience integrating electrical and process control systems, • Strong leadership, organizational, and communication skills for cross-functional collaboration, • Experience specifying and designing electrical components, including MCCs, VFDs, control panels, and power distribution systems, • Knowledge of server infrastructure and virtualization technologies for robust DeltaV system deployment, • Extensive experience designing and implementing batch control systems within regulated Life Sciences environments, • Experience in OEM system integration using OPC UA, Ethernet/IP, and other industrial communication protocols, • Ability to plan, specify, and manage DeltaV system licensing to optimize project implementation, • Knowledge of Rockwell Automation, Inductive Automation Ignition, Siemens PCS7, or other DCS/SCADA systems is a plus