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, including protocol writing and execution, field verification, and the development of summary reports at the client site.

Tutti i candidati sono invitati a leggere attentamente la seguente descrizione del lavoro e le relative informazioni prima di candidarsi.
Key Responsibilities

- Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
- Write and execute protocols, perform field verification, and develop summary reports at client sites.
- Provide cGMP leadership and guidance for the integration and delivery of CQV services for Life Sciences clients.
- Apply excellent technical problem‑solving and troubleshooting skills, addressing typical project technical issues and deadlines.
- Work independently while quickly building and nurturing a project team.
- Manage the C&Q; documentation and execution lifecycle from SLIA generation through OQ completion.
- Support onsite and offsite activities such as FATs, SATs, IOQ and PQ executions, and system walkdowns.
- Be proficient in life science manufacturing processes (biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent).
- Familiarity with Baseline Guide 5 (Second Edition) is a plus.
- Have experience with isolator qualification protocols, VHP cycle development, and GMP‑based knowledge.
- Demonstrate expertise in Microsoft Word and Excel.
- Excellent oral and written English are required.
- Available for travel in Italy and abroad.





Position Requirements
- High attention to detail.
- Ability to multi‑task and take initiative to accomplish assigned tasks accurately.
- 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, especially 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.
- Provide cGMP leadership and guidance for CQV services.
- Excellent technical problem‑solving and troubleshooting skills.
- Ability to work independently and build a project team.
- Manage C&Q; documentation lifecycle from SLIA through OQ.
- Support onsite and offsite CQV activities such as FAT, SAT, IOQ, PQ, and system walkdowns.
- Knowledge of life science manufacturing processes in areas such as biotechnology, aseptic processing, and Gene Therapy.
- Familiarity with Baseline Guide 5 (Second Edition).
- Experience with isolator qualification protocols, VHP cycle development, and GMP knowledge.
- Expertise in Microsoft Word and Excel.
- Excellent oral and written English.
- Availability for travel in Italy and abroad.

Compensation

€34,000 to €45,000 gross per annum. xysqume The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience.

La selezione rispetta il principio delle pari occasione (l. 903/77).

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📌 CQV Engineer (Milano)
🏢 Cagents
📍 Milano