Project Manager- Commissioning & Qualification

Kelly Engineering has an exciting direct hire Project Manager
- Commissioning & Qualification (C&Q) role with an industry leader experiencing dynamic growth in the Indianapolis, IN area. This role offers a competitive compensation package along with significant opportunities for company growth in a supportive team environment.

The Commissioning & Qualification (C&Q) Project Manager is responsible for managing and executing commissioning and qualification activities for major pharmaceutical manufacturing projects. This role ensures compliance with regulatory and industry standards, supports project delivery excellence, and provides technical leadership to cross-functional teams. The C&Q Project Manager acts as a subject matter expert, overseeing planning, execution, and documentation to enable successful facility startup and sustained operations.

Key Responsibilities:

• Lead all C&Q activities across assigned systems, equipment, and facilities
• Prepare, review, and approve C&Q deliverables, including Project Validation Plans, User Requirements, IV/OV test plans, and summary reports
• Ensure compliance with GMP, FDA, and industry standards throughout all project phases
• Oversee and perform Installation Verification (IV) and Operational Verification (OV) testing
• Validate that systems are qualified and ready for operational use
• Identify opportunities for process improvement within commissioning and qualification activities
• Collaborate with equipment vendors, contractors, and client representatives to ensure smooth project execution.

Skills &

Qualifications:

• Previous experience managing capital projects in a regulated manufacturing environment
  - Pharma, Biotech, Chemical, Med Device or related industry
• BS Degree in Engineering or related discipline
• Strong understanding of commissioning, qualification, and validation methodologies
• Effective communicator able to influence across disciplines and levels

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in the Kelly Engineering network. That means our team of expert engineering recruiters will have access to your profile, making your opportunities limitless.