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CQV Project Manager

Job in Indiana, Indiana County, Pennsylvania, 15705, USA
Listing for: Cagents
Full Time position
Listed on 2025-12-02
Job specializations:
  • Engineering
    Quality Engineering, Operations Manager, Pharma Engineer
Job Description & How to Apply Below
Location: Indiana

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.

Join us and become a key player in delivering the future of advanced medicine!

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