• BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience • 5 – 12 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have 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, etc. • Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. • Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues • High attention to detail • Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines • Ability to work independently, while quickly building and nurturing a project team • Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion. • Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns • Experience in planning / directing C&Q activities • Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience. • Familiarity with Baseline Guide 5 (Second Edition) a plus |
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