
Commissioning Agents Inc
Published: June 11, 2024
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Description
Position Description:
- We are now seeking a CQV Engineer to join our growing operations in Italy.
- The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation.
- These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
- The role of a CQV Engineer in CAI is to: Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
- Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.
Position Requirements:
- High attention to detail
- Ability to multi-task and take initiative to accomplish assigned tasks accurately by established BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
- Minimum 4 8 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 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
- 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
Expected skills:
- Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge
- Expertise in Microsoft Word and Excel
- Excellent oral and written English are required.
Available for travel in Italy and abroad. The selection respects the principle of equal opportunities (l. 903 / 77)