Validation Engineer

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

Descrizione del lavoro

A leading company in the Life Sciences sector seeks professionals to support the Commissioning, Qualification, and Validation (CQV) process of pharmaceutical facilities. The role encompasses executing protocols, managing documentation lifecycles, and leading cGMP initiatives while requiring strong communication and strategic capabilities. Applicants should have a science or engineering degree with relevant regulatory experience.

Competenze

• 4-8 years in FDA-regulated commissioning/qualification.
• Proficiency in GMP protocols.
• Ability to travel across Italy and Europe.

Mansioni

• Support documentation for Commissioning, Qualification, and Validation of pharmaceutical facilities.
• Write and execute protocols, develop summary reports.
• Manage lifecycle of C&Q documentation and troubleshoot technical issues.

Conoscenze

Excellent communication skills

Strategic planning

Customer focus

Leadership

Safe leadership

Formazione

Relevant science or engineering degree

Descrizione del lavoro

CAI is a professional services company established in 1996 with nearly 800 employees worldwide. We serve the Life Sciences and Mission Critical industries by delivering critical solutions in high-stakes environments through rigorous processes, field-tested methods, and elite expertise developed over 30 years.

Our Purpose guides us:

· To be the trusted solution for our clients as they build a better working world and improve the human experience.

We uphold our Foundational Principles:

· Act with integrity

· Serve each other

· Serve society

· Work for our future

We are dedicated to excellence, innovation, and redefining industry standards. We operate at the intersection of wisdom, technology, and humanity, with operational readiness as our core focus. We strive for continuous advancement through precision, efficiency, and a forward-thinking mindset.

Key Responsibilities:

1. Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
2. Write and execute protocols, develop summary reports at client sites.
3. Provide cGMP leadership for CQV services in Life Sciences.
4. Troubleshoot and resolve technical issues related to facilities and equipment startups.
5. Manage the lifecycle of C&Q documentation from start to finish.
6. Support onsite and offsite activities such as FATs, SATs, IQ/OQ/PQ executions, and system walkdowns.
7. Possess knowledge of biotech, aseptic processing, fill/finish, OSD, Gene Therapy, or similar manufacturing processes.

Qualifications include a relevant science or engineering degree or equivalent experience, 4-8 years in FDA-regulated commissioning/qualification, proficiency in GMP protocols, and ability to travel across Italy and Europe. Excellent communication skills in English are required.

Additional skills involve strategic planning, customer focus, leadership, influence, talent development, results orientation, and safe, courageous leadership.

This job is active and accepting applications.