Validation Engineer

CAI; Pisa; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

Join a forward-thinking company as a CQV Engineer, where you will play a crucial role in the documentation and execution of commissioning, qualification, and validation processes for pharmaceutical facilities. This position offers the opportunity to work on-site and off-site, ensuring compliance with industry standards while developing your technical skills in a dynamic environment. You will be responsible for protocol writing, field verification, and leading cGMP initiatives, making a significant impact on the life sciences sector. If you are detail-oriented and passionate about quality assurance in pharmaceutical manufacturing, this is the perfect role for you.

Competenze

• 4-8 years of experience in commissioning and qualification in FDA regulated industry.
• Proficient in life science manufacturing processes and GMP knowledge.

Mansioni

• Support documentation for CQV of pharmaceutical facilities and utilities.
• Manage C&Q documentation and execution lifecycle from SLIA to OQ.

Conoscenze

Attention to Detail

Technical Problem-Solving

Troubleshooting Skills

Ability to Multi-Task

Leadership in cGMP

Independent Working

Formazione

BS or MS in a relevant science or engineering field

Equivalent years of hands-on experience

Strumenti

Microsoft Word

Microsoft Excel

Descrizione del lavoro

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. 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:

1. Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
2. Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.

Position Requirements:

1. High attention to detail.
2. 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.
3. 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.
4. Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
5. Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues and deadlines.
6. Ability to work independently, while quickly building and nurturing a project team.
7. Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
8. Support onsite and offsite activities, such as: FATs, SATs, IOQ, and PQ Executions and System Walkdowns.
9. Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
10. Familiarity with Baseline Guide 5 (Second Edition) a plus.
11. 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).
12. Expertise in Microsoft Word and Excel.
13. Excellent oral and written English are required.
14. Available for travel in Italy and abroad.