31 lug - Italia
Jobtailor
Responsibilities
- Develops documentation to support Commissioning, Qualifications, and Validation
- Responsible for protocol writing and execution, field verification, and development of summary reports at client sites
- Provide cGMP leadership and guidance for the integration and delivery of CQV services for Life Sciences clients
- Support onsite and offsite activities such as FATs, SATs, IOQ, and PQ Executions and System Walkdowns
Requirements
- BS or MS in a relevant science or engineering field, or equivalent hands‑on experience
- Minimum 4-8 years’ experience performing commissioning and/or qualification activities in an FDA regulated industry
- Experience in facilities and equipment startup, walk‑downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs;, IQ/OQ/PQs, generation & execution
- Excellent technical problem‑solving and troubleshooting skills
- Familiarity with Baseline Guide 5 (Second Edition) a plus
- Expertise in Microsoft Word and Excel
- Excellent oral and written English
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