Pharma CQV Engineer - Commissioning & Validation

CAI; Bologna; In loco; EUR 45.000 - 57.000; Tempo pieno

Descrizione del lavoro

CAI is seeking a CQV Engineer to join our Italian operations. The role develops documentation to support Commissioning, Qualifications, and Validation, including protocol writing, field verification, and summary reports at client sites.

Required are 4–8 years of FDA-regulated CQV experience, knowledge of GMP processes, and strong English. Expect travel in Italy and abroad, with compensation €45,000–€57,000 gross per year.

Competenze

• 4–8 years’ experience performing commissioning/qualification in an FDA-regulated industry.
• Experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), FAT/SAT, URS, IQ/OQ/PQs.
• Provide cGMP leadership for CQV services for Life Sciences clients.
• Excellent technical problem-solving skills and ability to work independently.

Mansioni

• 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.
• Manage 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.

Conoscenze

Attention to detail

Multi-tasking

Problem solving

Independent work

Team collaboration

English proficiency

Formazione

BS or MS in a relevant science or engineering field

Strumenti

Microsoft Word

Microsoft Excel

Descrizione del lavoro

CAI is seeking a CQV Engineer to join our Italian operations. The role develops documentation to support Commissioning, Qualifications, and Validation, including protocol writing, field verification, and summary reports at client sites.

Required are 4–8 years of FDA-regulated CQV experience, knowledge of GMP processes, and strong English. Expect travel in Italy and abroad, with compensation €45,000–€57,000 gross per year.