documentation aligned with GAMP, FDA, and cGMP requirements Develop and execute IQ/OQ/PQ protocols Ensure compliance with 21 CFR... regulations and FDA requirements for automated systems Experience with qualification protocols (IQ/OQ/PQ) and validation...
, and manufacturing documentation. Develop and execute validation protocols (IQ/OQ/PQ) for equipment in compliance with cGMP, FDA...
, Validation Plans, IQ/OQ/PQ, Validation Reports, Traceability Matrices, Automated Testing Artifacts) to ensure FDA-regulated... validation lifecycle documentation (e.g., URS, risk assessments, IQ/OQ/PQ, traceability matrices). Experience supporting...
. Must Have Experience in equipment IQ Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process...
project/part qualification deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R...
and at least 2 years (BA is PQ only) in associate degree in industrial or maintenance technology OR at least 2 years of maintenance...
initiatives in operational excellence, Design for Manufacturability (DFM), process validation (IQ/OQ/PQ), and production readiness...
Experience working in fast-paced, regulated manufacturing environments Process validation experience (IQ, OQ, TMV, PQ...
, qualification, or validation activities (IQ/OQ/PQ support) as appropriate to project scope. Collaborate with cross‑functional...
where your work will truly matter. Your role with the company: ✅ Lead/support process validations (IQ/OQ/PQ) ✅ Develop validation...