QA Validation Specialist 3

Equipment Validation Analyst This role supports Quality Control, Manufacturing, and other departments in the design, operation, and troubleshooting of equipment. Responsibilities Drive/own the validation plans and execution of equipment changes and process improvements. Execute Installation Qualifications/Operational Qualifications and draft Performance Qualifications as required. Perform Equipment Validation activities, including Validation Maintenance Quality Systems review and requalification, to ensure GMP equipment remains continuously validated. Program, organize, and maintain Validation equipment and supplies, including dataloggers and probes. Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Clean‑In‑Place (CIP), Steam‑In‑Place (SIP), Autoclaves, Clean Utilities Shipping Validation, temperature mapping of controlled storage rooms, and equipment. Develop validation protocols from plans and engineering documents. Provide basic technical support when reviewing and approving SOPs, protocols, change controls, deviations, CAPA, etc. Perform assigned Quality Systems activities within Document Management System (DMS) and TrackWise Quality System (Change Control, Deviation, CAPA). Perform other duties as assigned. Requirements Experience with Kneat is absolutely required. Experience with Ellab for Temp Mapping is a plus. Manager seeks candidates with a background in Cleaning Validation (CIP, COP, SIP). 95% of equipment is Single‑Use, so Cleaning Validation is limited mainly to media hold/media fill and drafting SOPs. Other equipment includes autoclaves, parts washers, and storage equipment (cold and ambient). The role requires building equipment requalification in Kneat. The role focuses on Equipment Validation and Cleaning Validation. #J-18808-Ljbffr Katalyst CRO