Senior Commissioning, Qualification
3 days ago
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,
- Create, review 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.
- Relevant experience in validation activities (including the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents)
- Leading daily validation meetings with cross functional teams in resolving validation issues.
- Experience in equipment qualification including analytical instrumentation and manufacturing equipment.
- Work experience in Pharmaceutical or BioPharma industries
- Hands on validation execution experience
- Able to execute activities in cGMP environment, including cleanrooms or technical areas.
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Singapore CAI Full timeThe Commissioning & Qualification Engineer's responsibility will be to provide technical oversight on behalf of client of a third party commissioning team responsible for the C&Q efforts in the Warehouse/Dispensary/Drumstore Buildings. The primary equipment in the Warehouse/Dispensary/Drumstore consists of three Dispensaries, a Subdivision Suite and Sampling...
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