Senior Manufacturing Engineer
content tools) Mentor/Lead the validation of equipment and processes as required (IQ, OQ, PQ) Mentor and implement capacity...
content tools) Mentor/Lead the validation of equipment and processes as required (IQ, OQ, PQ) Mentor and implement capacity...
(Line Balance, work content tools) Lead development of validation documentation (IQ, OQ, PQ) Develop programs for training...
content tools) Mentor/Lead the validation of equipment and processes as required (IQ, OQ, PQ) Mentor and implement capacity...
(Line Balance, work content tools) Lead development of validation documentation (IQ, OQ, PQ) Develop programs for training...
delivery forecasting Assess risk through FMEAs and develop process validation plans (MVP, IQ/OQ/PQ) to be executed... preferred) Demonstrated experience developing process validation plans, including IQ/OQ/PQ protocols/reports...
. Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex...
. Conduct risk analysis, maintain and update the Validation Master Plan, and develop Performance Qualification (PQ) protocols...
procedures and regulatory standards. Lead the execution of validation activities (IQ/OQ/PQ), test method validation (TMV...
requirements gathering, risk assessments (GAMP 5), protocol development (IQ/OQ/PQ), and traceability matrices. Regulatory...
requirements gathering, risk assessments (GAMP 5), protocol development (IQ/OQ/PQ), and traceability matrices. Regulatory...