Project Manager- Commissioning & Qualification

Kelly Science, Engineering, Technology & Telecom; Indianapolis (IN); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation package

Opportunities for company growth

Job summary

A leading engineering company in the Indianapolis area seeks an experienced Project Manager for Commissioning & Qualification (C&Q). This role involves managing C&Q activities for pharmaceutical manufacturing projects, ensuring compliance with regulatory standards, and providing technical leadership. The successful candidate will lead project execution, collaborate with vendors, and contribute to process improvement initiatives. A BS in Engineering and experience in regulated environments are essential. Competitive compensation package offered.

Qualifications

• Experience managing capital projects in Pharma, Biotech, Chemical, or similar industries.
• Strong understanding of commissioning, qualification, and validation methodologies.
• Ability to influence and communicate effectively across disciplines.

Responsibilities

• Lead all C&Q activities for assigned projects.
• Prepare and approve C&Q deliverables.
• Ensure compliance with industry standards throughout project phases.
• Perform Installation Verification (IV) and Operational Verification (OV) testing.
• Collaborate with vendors and client representatives for smooth execution.

Skills

Project management

GMP understanding

Effective communication

Regulated manufacturing knowledge

Education

BS Degree in Engineering

Job description

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.