CQV Project Manager

Project Manager – Switzerland / EUDrive 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 forMust 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 medicineWe 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.We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.