Validation Engineer

Cagents; Pisa; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading company in the life sciences sector is seeking a CQV Engineer to support Commissioning, Qualification, and Validation of pharmaceutical facilities in Italy. The role involves protocol writing, execution, and providing cGMP leadership. Candidates must possess technical problem-solving skills and experience in an FDA regulated environment, with the expectation of availability for travel. Comprehensive benefits include health insurance, pension contributions, and professional development opportunities.

Servizi

Comprehensive Health Insurance

Paid Time Off

15% Company Pension Contribution

Company Paid Life Assurance

Company Paid Income Protection

Career / Professional Development Opportunities

Competenze

• Minimum 4-8 years’ experience in commissioning/qualification in FDA regulated industry.
• Experience with facilities/equipment startup and troubleshooting.
• Excellent English required, proficiency in life science manufacturing process.

Mansioni

• Support documentation for Commissioning, Qualification, and Validation.
• Responsible for protocol writing, execution, and summary reports.
• Manage C&Q documentation and lifecycle from SLIA to OQ completion.

Conoscenze

Attention to detail

Technical problem-solving

GMP based knowledge

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

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 : Agent 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.

Suitable candidates must be available for travel throughout Italy and some European travel may be required.

Varies by Country, Below is a General Overview)

• Comprehensive Health Insurance coverage aligned with local region regulations
• Paid Time Off
• ESOP / 401K – 15% Company Contribution (US Only)
• 15% Company Pension Contribution (Europe and APAC Regions)
• Company Paid Life Assurance
• Company Paid Income Protection / Long-Term Disability
• Career / Professional Development Opportunities
• Additional benefits / leave entitlements based on local regional requirements.

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