- C&W Services (Boston, MA)
- …Reliability Engineer **Job Description Summary** This individual will provide support for GxP Facility Operations/Engineering department at Vertex GxP sites as ... Practices for new and existing equipment, facilities and utilities at GxP sites including asset management, calibration, preventative maintenance and spare parts.… more
- C&W Services (Boston, MA)
- …team, the lead Reliability Engineering will provide strategic and hands-on support for GxP Facility Operations and Engineering across Vertex GxP sites. This role ... focusing on maximizing equipment and system performance while ensuring compliance with GxP and Good Engineering Practices (GEP). The ideal candidate will lead… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Analytical Technology (PAT), and Knowledge Management. + Support technical/data system ownership of GxP and non- GxP systems such as Statistica and Spotfire. + Be ... data integrity, visibility, and usability. + Support data engineering solutions to automate GxP activities. + Support and coach other MS team members to enhance… more
- Rhythm Pharmaceuticals (Boston, MA)
- …administration of quality processes and records, ensuring operational excellence in GxP compliance, and maintaining a state of inspection readiness. The Manager, ... reconciliation with related systems and departments. + Assign and manage GxP training via Rhythm's Learning Management System, monitor compliance, and generate… more
- Sanofi Group (Cambridge, MA)
- …Infrastructure, Data, etc.), business analysts and agile teams to ensure GXP , validated features comply with defined standards, documentation and release with ... industry experience.** + Working knowledge of the regulatory environment (ie REMS, GXP , HIPAA, GDPR regulations and validated environments). + Proven experience as a… more
- Merck (Cambridge, MA)
- …for drug discovery. + Create and maintain documentation including SDLC deliverables ( GxP and non- GxP ), guidelines, SOPs, training materials, and user ... teams; experienced in Agile development principles and working in GxP -regulated environments. + Ability to collaborate effectively within multidisciplinary teams… more
- Insight Global (Boston, MA)
- Job Description This individual will provide support for GxP Facility Operations/Engineering department at Pharmaceutical client GxP sites as part of the ... Practices for new and existing equipment, facilities and utilities at GxP sites including asset management, calibration, preventative maintenance and spare parts.… more
- Insight Global (Raynham, MA)
- …real-world solutions that support production efficiency and quality standards Apply GxP standards throughout the design and documentation process Support market ... design Experience designing tooling fixtures for robotic equipment Familiarity with GxP standards Strong understanding of real-world manufacturing processes and how… more
- Bristol Myers Squibb (Devens, MA)
- …tasks through data and analytics; to own, review or approve Floor Quality GxP records including but not limited to procedures, CAPAs, change controls, impact ... Demonstrated experience with quality management systems + Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing… more
- CGI Technologies and Solutions, Inc. (Burlington, MA)
- …of systems using Veeva or Trackwise for QMS processes. * Ensure compliance with GxP and 21 CFR Part 11 regulations, and lead validation efforts using tools such ... use of HP ALM for test management and traceability. * In-depth knowledge of GxP , 21 CFR Part 11, and other relevant pharmaceutical regulations. * Proven ability to… more