Senior Commissioning, Qualification & Validation Engineer

PM Singapore is currently looking to expand the CQV capabilities. This role will be supporting one of our many clients in the field of commissioning, qualification and validation work within the Life Sciences space. Your day to day role would involve the following activities: Planning, performance, and coordination of Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubators, etc.), Clean Utilities Validation, and cleaning validation in accordance with internal procedures and industry standards. The qualification includes FAT, SAT, IQ, OQ, PQ of additional modifications of existing manufacturing process equipment, package units (e.g., Ultrafiltration Units, Chromatography Columns, autoclaves, FIT testers), COTS analytical instruments, freezers, etc. Create, review, and approve equipment qualification and analytical instrument lifecycle documentation, e.g., FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications. Lead investigations related to discrepancies identified during qualification activities. We would like to hear from candidates who have: Relevant experience in validation activities, including creation, pre-execution approval, execution, post-execution review, and approval of all validation lifecycle documents. Experience leading validation meetings with cross-functional teams to resolve validation issues. Experience in equipment qualification, including analytical instrumentation and manufacturing equipment. Work experience in Pharmaceutical or BioPharma industries. Hands-on validation execution experience. Ability to execute activities in a cGMP environment, including cleanrooms or technical areas.

#J-18808-Ljbffr