Validation Engineer

CAI; Rimini; In loco; EUR 40.000 - 65.000; Tempo pieno

Descrizione del lavoro

A leading company in life sciences is seeking a CQV Engineer in Italy. The role involves developing documentation for commissioning, qualification, and validation of pharmaceutical facilities, requiring strong problem-solving skills and a solid background in relevant engineering or science fields. Candidates should have substantial experience in FDA regulated environments and be available for travel.

Competenze

• 4-8 years' experience in commissioning and/or qualification activities in FDA regulated industry.
• Proficient in life science manufacturing processes.
• Excellent oral and written English.

Mansioni

• Support documentation for CQV of pharmaceutical facilities.
• Responsible for protocol writing, execution, and reporting.
• Manage C&Q documentation lifecycle from SLIA to OQ completion.

Conoscenze

Attention to detail

Technical problem-solving

Project management

GMP knowledge

Calibration instruments knowledge

Excellent communication skills

Formazione

BS or MS in a relevant science or engineering field

Strumenti

Microsoft Word

Microsoft Excel

Descrizione del lavoro

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 and 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 : GMP based knowledge, qualification protocols execution and reporting, use of calibration instruments for pharmaceutical equipment testing (autoclaves, HVAC, fume hood, filling lines, oral solid production equipment).
• Expertise in Microsoft Word and Excel.
• Excellent oral and written English are required.
• Available 100% for travel in Italy and abroad.

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