Commissioning and Qualification Engineer

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

Your day to day role would involve the following activities:

• 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 discrepancies identified during qualification activities.

We would like to hear from candidates who have:

• Experience in coordinating the commissioning and qualification activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
• Experience in leading daily validation meetings with cross functional in resolving validation issues.
• Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
• Experience in ASTM2500 of process equipment commissioning and qualification (Ultrafiltration units and chromatography column is preferred)
• Relevant work experience in Pharmaceutical and/or Biopharmaceutical industries
• Hands on validation execution experience
• Review validation documents
• Write validation protocols and reports
• Able to execute activities in cGMP environment, including cleanrooms or technical areas.
• Attention to detail