instructions and process documentation Lead IQ/OQ/PQ process validation Partner with vendors to design/build assembly equipment...
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...
, IQ, OQ, PQ protocols and reports for process equipment, clean utilities (WFI, clean steam, gases), HVAC/cleanrooms... experience executing IOQ/PQ on automated equipment (filling lines, isolators, lyophilizers, device assembly equipment strongly...
. Responsibilities: Author, execute, and summarize commissioning and qualification deliverables including FAT/SAT, IQ, OQ, PQ protocols...-on CQV experience in pharmaceutical, biotechnology, and/or medical device industries Direct experience executing IOQ/PQ...
Familiarity with equipment qualification (FAT/SAT/IQOQ/PQ), utility systems, QC laboratory methods, cleaning validation...
, including vendor assessments, system risk assessments, validation plans, requirements specifications, IQ/OQ/PQ protocols...
Level Risk Assessments), DI (Data Integrity) Assessments, DR/DQ, Specifications, IQ/OQ/PQ Qualification Protocols/Issues...
and prepare technical reports Perform IQ/OQ/PQ and maintain lab equipment Follow safety procedures and good laboratory practice...
protocols, review results, and/or draft/review reports for sterilization validations under IQ/OQ/PQ framework in conformance...
Manufacturing and QA with Performance Qualification (PQ) activities if applicable. Related Activities: Participate or lead...