. This includes equipment specification, procurement, installation / start-up, testing, onboarding, and qualification (IQ, OQ, PQ... understanding of cGMP systems and FDA/EU regulations Qualification Experience - Experience with IQ/OQ/PQ and commissioning...
equipment qualification (IQ, OQ, PQ) Work on yield improvement initiatives and root-cause investigations for failures...
and optimize processes and tooling through IQ/OQ/PQ, Gage R&R studies, process capability studies, and design of experiments...
requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, safety and environmental assessments...
inspection platforms. Direct equipment installation, calibration, IQ/OQ/PQ validation, and recipe standardization for new...
) and equipment IQ/OQ/PQ activities, including Gage R&R studies, right-sizing validation effort to risk (CSA principles... with equipment/process validation (IQ/OQ/PQ) and test method validation (TMV), including Gage R&R methodology Working knowledge...
&D to pilot and full manufacturing scale Lead process transfer to production, including equipment qualification (IQ, OQ, PQ...
and approval processes. Support process qualification and validation activities, including IQ/OQ/PQ. Communicate directly... with IQ/OQ/PQ or manufacturing process validation. Experience managing nonconformances and deviations. Strong technical...
protocols and reports (IQ, OQ, PQ, CSV, process validation, cleaning validation). Ensure compliance of validation activities...
, managing NPI schedules, design transfer deliverables, and milestone targets. Execute process validations (IQ/OQ/PQ...