CQV Engineer

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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