- J&J Family of Companies (Danvers, MA)
- …repairing, and troubleshooting production manufacturing equipment and be well-versed in IQ , OQ, PQ validation processes and Good Manufacturing Practices (GMP) for ... downtime and optimized production efficiency. + Support Installation Qualification ( IQ ), Operational Qualification (OQ), and Performance Qualification (PQ) validation… more
- Cognizant (Boston, MA)
- …Risk Assessment, Validation Plan, System Test Plan, Test Summary Reports ( IQ /OQ/UAT), Validation Report, etc. following industry standard GAMS 5 and/or following ... the client Quality standards. Author and review test scripts ( IQ , OQ, PQ) Perform IQ (application and devices), OQ (including the Siemens CAMSTAR / OpCenter MES… more
- Bristol Myers Squibb (Devens, MA)
- …QC lab, including documentation associated with requirements gathering, development, IQ /OQ/PQ, and test method validation. Apply technical knowledge, regulatory ... into QC lab, including documentation associated with requirements gathering, development, IQ /OQ/PQ, and test method validation. + SME for training and mentoring… more
- J&J Family of Companies (Danvers, MA)
- …forecasting + Assess risk through FMEAs and develop process validation plans (MVP, IQ /OQ/PQ) to be executed at supplier + Partner with internal design teams to ... preferred) + Demonstrated experience developing process validation plans, including IQ /OQ/PQ protocols/reports required. Experience designing and executing Gauge R&R… more
- Medtronic (Danvers, MA)
- …relevant international standards. Coordinate process validations using IQ /OQ/PQ (Installation Qualification, Operational Qualification, and Performance ... & DFMEA; ISO 9001, ISO 14971, ISO13485, and FDA QSR Part 820; IQ /OQ/PQ and CAPA; Developing manufacturing processes and equipment; Root cause and defect analysis,… more
- J&J Family of Companies (Danvers, MA)
- …and review validation documentation including Validation Master Plans (VMP), protocols ( IQ /OQ/PQ), risk assessments, and final reports. + Design and execute ... Strong working knowledge of FDA, ISO, and GHTF validation requirements, including IQ /OQ/PQ frameworks. + Proven ability to develop and execute complex validation… more
- Takeda Pharmaceuticals (Lexington, MA)
- …regulations. Create and maintain validation life cycle documentation, including IQ /OQ/PQ protocols and reports, risk assessments, and traceability matrix. Provide ... Place (CIP), Clean Out of Place (Parts Washers) (COP); develop and execute IQ /OQ/PQ protocols to qualify sterilization systems (autoclaves and Steam in Place SIP)… more
- Sanofi Group (Cambridge, MA)
- …support sites with knowledge transfer, training, validation plan and execution of IQ /OQ/PQ in accordance with regulatory, company & site requirements. Will often ... support sites with continuous improvement activities to optimize efficiency, productivity, and asset utilization. + Lead the improvement and standardization of packaging platforms and technical requirements of existing products with focus on sustainability and… more
- Teleflex (Chelmsford, MA)
- …authoring and executing validation plans, engineering studies, Installation Qualification ( IQ ), Operational * Qualification (OQ), Process Qualification (PQ), and ... Test Method Validation (TMV) in accordance with ISO, FDA and corporate guidelines. * Keep track of industrial trends in applications and technologies, including practices and engineering tools. Maintain knowledge of technology changes to be able to implement… more
- Medtronic (Billerica, MA)
- …regulated environment + Experience Process and equipment Validation and Qualification ( IQ ,OQ,PQ) + Experience with automation, vision, PLC processes + Strong ... problem-solving skills + Project management experience + Strong written and verbal communication skills **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to… more