Commissioning and Qualification Engineer

Due to current demand, PM Group is currently looking to expand the CQV team.

• Planning, Performance, and Coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubator etc), Clean Utilities Validation and cleaning validation in accordance with internal procedures and industry standards.
• The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional / modifications of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers,
• Experience to creates, reviews and approve equipment qualification and analytical instruments lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
• Can lead investigation revolving around...