CQV Project Manager

AI overview

Lead mid- to large-scale life sciences projects, guiding critical commissioning, qualification, and validation (CQV) activities to ensure compliant project execution.
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. 

Perks & Benefits Extracted with AI

  • Other Benefit: Collaborative culture: team-first environment where successes are celebrated together.
Ace your job interview

Understand the required skills and qualifications, anticipate the questions you may be asked, and study well-prepared answers using our sample responses.

Project Manager Q&A's
Report this job
Apply for this job