- Aequor (Waltham, MA)
- …Quality System records, manufacturing documents, analytical methods, and qualification/ validation documentation. On-site oversight of CMO operations as needed. ... and preventive actions. Suggest the development, implementation, and maintenance of quality systems, processes, and procedures related to GMP operations… more
- Randstad (North Billerica, MA)
- …an immediate contract role for approximately 4 months in the Burlington, MA area! The Quality Engineer will work directly with the engineering team's quality ... needs in this area. This person will also be involved in internal quality audits to ensure its adequacy, effectiveness, and adherence to established standards. The… more
- Bristol-Myers Squibb Company (Devens, MA)
- …solutions. Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements. Completing training assignments to ensure ... must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a… more
- Bristol Myers Squibb (Devens, MA)
- …the design and build of new manufacturing plants to make sure the engineering approaches consider our harmonized validation framework that is compliant with ... therapy. + Create, maintain, and deploy global cell therapy validation technical standards via the quality system....trials. **Qualifications & Experience** + BS/MS.S/Ph. D in Chemical Engineering or Life Science with 12+ years of relevant… more
- Stantec (Burlington, MA)
- …the designs that support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and facilities meet the ... hear from you. We have two immediate openings in our Buildings Commissioning/ Validation group for an enthusiastic, diligent and experienced Commissioning / … more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in ... and immunology. You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards… more
- Amazon (Westborough, MA)
- …Robotics (AR) Robotics Manufacturing and Technical Operations (RMTO) organization manufactures high- quality robotics and gets the right materials to the right place ... Introduction (NPI). . Implement technology and tool improvements to impact Safety, Quality , and Cost targets. . Perform critical process reviews including Risk and… more
- J&J Family of Companies (Danvers, MA)
- …troubleshooting production manufacturing equipment and be well-versed in IQ, OQ, PQ validation processes and Good Manufacturing Practices ( GMP ) for building ... its maintenance, repair, and validation . + Strong knowledge of IQ, OQ, PQ validation processes and GMP compliance. + Working knowledge of SAP preferred +… more
- Rhythm Pharmaceuticals (Boston, MA)
- …our Boston or Amsterdam office to play a key role in ensuring quality and regulation-based compliance during the manufacture and distribution of Rhythm clinical and ... be a key team member of the Technical Operations, GMP and GDP QA Group. Their main activities include...Their main activities include managing the day-to-day administration of quality processes and records, ensuring operational excellence in GxP… more
- Sanofi Group (Framingham, MA)
- …and Global Quality . . **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing of US FDA inspection findings ... Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up** for US FDA exposed… more
- Sanofi Group (Framingham, MA)
- … Engineering Documentation interface with stakeholders (ie Project Management, Validation and Quality ) via strong working relationships, ensuringdeliverables ... that meet CGMP and site quality requirements. + Manage, mentor and develop ...for the Framingham Biologics site for the management of GMP As-Built drawings and Non- GMP Master Drawings.… more
- Amgen (Cambridge, MA)
- …responsible for late phase analytical development, including method development, method validation , method transfer, process and product development support, and ... GMP testing of late phase drug substances and drug...developing the analytical tools to gain understanding of key quality attributes in product and process for late phase… more
- Bristol Myers Squibb (Devens, MA)
- …with requirements gathering, development, IQ/OQ/PQ, and test method validation . Apply technical knowledge, regulatory requirements, and scientific principles ... qPCR, flow cytometry). Lead site implementation of automation systems into the GMP QC laboratory. + Work with internal automation development team and external… more
- Sanofi Group (Framingham, MA)
- …facility support and provide technical expertise. + Coordinate and support validation , engineering and production assignments according to schedule without ... analysis of results and write technical reports. + Ensure GMP compliance of all activities performed. + Represent QC...compromising quality + Specify, procure, and coordinate validation … more
- Cognizant (Boston, MA)
- …in cross-functional program leadership meetings, ensuring alignment between automation, process engineering , digital/MES, and quality teams . Serve as the ... technical decision-making. . Clear understanding of automation compliance requirements, including GMP and validation principles. . Excellent communication skills… more
- ThermoFisher Scientific (Waltham, MA)
- …that support GMP Manufacturing systems that are in alignment with GMP quality policies and procedures. Determine and document processes work instructions ... Fisher Pharma Services Group (PSG) division. Manage multiple business critical GMP system analyst activities in a global network. Oversee technical installation… more
- Medtronic (Danvers, MA)
- …and other functions that affect product performance. Work to develop various validation protocols, test methods and test fixtures. Navigate various risk activities ... Mode & Effects Analysis). Navigate complex industry and government regulations to include ISO quality system - ISO 9001, ISO 14971, ISO13485, FDA QSR ( Quality … more
- AbbVie (Worcester, MA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description An Engineering Manager is responsible for leading a team of six to eight ... of Cell Culture and Purification activities within Biologics manufacturing. This engineering professional who, working with little or no supervision, applies… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Description** The Principal R&D Systems Engineer will lead or support Systems Engineering aspects on new product development efforts within the Olympus Surgical ... looked upon as a subject matter expert (SME), and will provide project and engineering leadership in all phases of device development, as well as ensure compliance… more
- Catalent Pharma Solutions (Chelsea, MA)
- …clinical and commercial manufacturing. The candidate provides support in automation engineering , design, and validation . The Automation Engineer II contributes ... The Automation Engineer II is expected to assist senior engineering staff in the design and implementation of automation...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
