C&Q Project Manager – GMP/FDA Compliance Leader

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

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.