Digital Systems Validation Lead
-based systems Strong understanding of CSV lifecycle concepts including IQ/OQ/PQ or equivalent lifecycle validation models...
-based systems Strong understanding of CSV lifecycle concepts including IQ/OQ/PQ or equivalent lifecycle validation models...
regulated field. Must Have Experience in equipment IQ Experience in OQ (Operational Qualification) and PQ (Performance...
activities. Plan and execute process validation activities (IQ/OQ/PQ) in compliance with FDA QSR, ISO 13485, and applicable..., Chemical or related field) required;Advanced degree preferred. Must have strong knowledge in: Process validation (IQ/OQ/PQ...
and corrective actions Support new and transferred projects using APQP, PPAP and IQ/OQ/PQ methodologies Lead, develop and mentor..., PFMEA and qualification processes (IQ/OQ/PQ) Familiarity with Lean Manufacturing and supplier quality improvement...
(IQ/OQ/PQ) for a medical device production facility. The role involves ensuring that manufacturing systems, equipment... (PQ) activities for manufacturing equipment and processes Develop, review, and execute validation protocols and reports...
validations (IQ/OQ/PQ). Perform First Article Inspections (FAI) and reporting. Develop PFMEA, Control Plans, risk assessments...'s in Engineering (Quality/Mechanical/Biomedical/Industrial). Top Skills (Must Have): Process Validation (IQ, OQ, PQ). Validation...
, and structured problem-solving methodologies Lead and maintain process validations, including PFMEAs, OQ/PQ, PPAPs, FAIRs...
and execute process validation (IQ, OQ, PQ), risk assessments (per ISO 13485), and process control strategies to support robust...
validation (IQ/OQ/PQ), and full production ramp Define process flow diagrams (PFDs), equipment requirements, controls interfaces... manufacturing processes Familiarity with equipment qualification (IQ/OQ/PQ), control plans, APQP, and ISO 9001 / IATF 16949...
, and execute validation documentation including IQ/OQ/PQ protocols and qualification plans Perform and lead risk assessments, gap... with Computer Systems Validation (CSV), CQV, or automation validation Experience writing and executing IQ/OQ/PQ validation...