Responsibilities

- Develop the documentation to support Commissioning, Qualifications, and Validation.
- Responsible for protocol writing and execution, field verification, and development of summary reports at client sites.
- Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.

Requirements

- High attention to detail.
- Ability to multi-task and take initiative to accomplish assigned tasks accurately.
- Established BS or MS in a relevant science or engineering field, or equivalent years of hands‑on experience.
- Minimum 2–3 years’ experience performing commissioning and/or qualification activities in an FDA regulated industry.
- Experience in facilities and equipment startup, walkdowns & 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 Life Sciences clients.




- Excellent technical problem‑solving and troubleshooting skills, with solid knowledge of typical project technical issues.
- 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) is 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 is required.
- Available for travel in Italy and abroad.

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📌 CQV Engineer (Milano)
🏢 Jobtailor
📍 Milano