CQV Project Manager
Switzerland
Europe Life Sciences – Central Europe /
Full Time /
On-site
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!
We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties.
