Job Description & How to Apply Below
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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