More jobs:
CQV Project Manager
Job in
Indiana, Indiana County, Pennsylvania, 15705, USA
Listed on 2025-12-02
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
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.
- 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.
- Experience with complex or multi‑site project coordination.
- Prior experience leading international project teams.
- 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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