Validation Engineer

CAI; Pisa; In loco; EUR 45.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading company in the Life Sciences sector is seeking a CQV Engineer to support the Commissioning Qualification and Validation processes in Italy. The successful candidate will be responsible for documentation, protocol writing, and field verification, requiring a strong technical background and significant industry experience. This role is pivotal in ensuring cGMP compliance and assists with various validation activities on pharmaceutical projects.

Competenze

• Minimum 4-8 years experience in commissioning and/or qualification activities in FDA-regulated industry.
• Ability to meet deadlines and work independently.

Mansioni

• Support documentation for the Commissioning Qualification and Validation of pharmaceutical facilities.
• Responsible for protocol writing, field verification, and development of summary reports.

Conoscenze

Technical problem-solving

GMP-based knowledge

Reporting

Use of calibration instruments

Python

Technical Writing

Formazione

BS or MS in a relevant science or engineering field

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 individuals are responsible for protocol writing, 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, field verification, and development of summary reports at client sites.

Position Requirements :

• High attention to detail
• Ability to multitask and take initiative to accomplish assigned tasks accurately, with a BS or MS in a relevant science or engineering field, or equivalent hands-on experience.
• Minimum 4-8 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, pharmaceutical manufacturing processes, FAT/SAT, URS design review, P&IDs, IQ/OQ/PQs is preferred.
• 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.
• Ability to meet deadlines
• Ability to work independently while building and nurturing a project team.
• Manage C&Q documentation and lifecycle from SLIA generation through to OQ completion.
• Support onsite and offsite activities such as FATs, SATs, IOQ, PQ executions, and system walkdowns.
• Proficient in life science manufacturing processes, including biotech, aseptic processing, fill/finish, OSD, Gene Therapy, or equivalent experience.
• Familiarity with Baseline Guide 5 (Second Edition) is a plus

Expected Skills :

GMP-based knowledge, qualification protocols, reporting, and use of calibration instruments for pharmaceutical equipment testing (autoclaves, HVAC, fume hoods, filling lines, oral solid production equipment).

Expertise in Microsoft Word and Excel.

Excellent oral and written English skills are required.

Suitable candidates must be available for travel throughout Italy, with some European travel possibly required.

Key Skills

Python, SOC, Debugging, C / C++, FDA Regulations, Minitab, Technical Writing, GAMP, OS Kernels, Perl, cGMP, Manufacturing.

Employment Details :

• Type: Full-Time
• Experience: 4-8 years
• Vacancy: 1

Location: Validation Engineer • Pisa, Tuscany, Italy