CQV Project Manager

Project Manager – Switzerland / EU Drive life-changing therapies to market while building your career as an owner.

At CAI, every employee is an owner. Since 1996, we’ve grown to 850+ professionals worldwide by living our values: integrity, teamwork, respect, and a relentless focus on doing what’s right for our clients and society.

As a Project Manager, you’ll lead mid- to large-scale life sciences projects, guiding commissioning, qualification, and validation (CQV) activities from design to delivery. You’ll collaborate with recognized subject-matter experts and play a critical role in ensuring safe, compliant, and efficient project execution.

What you’ll do

• Provide cGMP leadership and guidance to integrate and deliver CQV services for life sciences clients.
• Manage mid-sized to large projects involving process equipment and clean utilities, including start-up and commissioning.
• Lead design reviews, equipment installation, and site acceptance activities.
• Write, review, and approve CQV documents in compliance with 21 CFR standards. Documents may include SOPs, impact assessments, risk assessments, specifications (URS/FRS/DDS), FATs, SATs, IQ/OQ/PQs, validation protocols, and commissioning test plans.
• Support onsite and offsite activities such as FATs, SATs, system walkdowns, and execution phases.
• Manage all aspects of C&Q, including change controls, contractor and vendor coordination, document control, and punch list management.
• Allocate project resources efficiently and track progress to ensure deliverables meet schedules.

What we’re looking for

Must have

• BS or MS in a relevant science or engineering field, or equivalent.
• 8+ years of commissioning, qualification, validation, and compliance experience in life sciences or regulated industries.
• Strong technical knowledge of EU and global regulatory requirements and proficiency in cGMP standards.
• Experience managing CQV deliverables across one or multiple projects.
• Skilled in planning and tracking project activities and schedules.
• Strong interpersonal skills to form relationships with internal teams and external clients.
• Excellent problem-solving, communication, and customer-focused skills.
• Familiarity with life science manufacturing processes, including biotech, aseptic fill/finish, OSD, or gene therapy.
• Flexibility to travel domestically and internationally as required.

Nice to have

• Experience with complex or multi-site project coordination.
• Prior experience leading international project teams.

What’s in it for you

• Employee ownership: your success drives collective success.
• Career investment: professional training, certifications, and development opportunities built into your role.
• Global exposure: collaborate on projects across Switzerland and beyond.
• Collaborative culture: team-first environment where successes are celebrated together.

Are you CAI Ready? Join us and become a key player in delivering the future of advanced medicine! #LI-JD1