Validation Engineer

CAI; L'Aquila; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

An established industry player is looking for a CQV Engineer to enhance its operations in Italy. This role involves developing essential documentation for Commissioning, Qualification, and Validation in pharmaceutical settings. The ideal candidate will possess a keen attention to detail, strong problem-solving skills, and the ability to manage multiple tasks effectively. With a focus on supporting clients in the Life Sciences sector, this position requires expertise in both technical documentation and practical execution. Join a dynamic team that values innovation and quality in ensuring compliance and operational excellence across various pharmaceutical processes.

Competenze

• 4-8 years experience in commissioning and qualification in FDA regulated industry.
• Proficient in life science manufacturing processes like biotech and aseptic processing.

Mansioni

• Support documentation for Commissioning, Qualification, and Validation of pharmaceutical facilities.
• Manage C&Q documentation and execution lifecycle from SLIA generation to OQ completion.

Conoscenze

Attention to detail

Technical problem-solving

Ability to multi-task

Leadership in cGMP

Formazione

Bachelor's or Master's in relevant field

Equivalent years of hands-on experience

Strumenti

Microsoft Word

Microsoft Excel

Calibration instruments

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