Kelly Science, Engineering, Technology & Telecom · 1 day ago
Project Manager- Commissioning & Qualification
Greater Indianapolis
Full-time
Onsite
Mid, Senior Level
$110K/yr - $160K/yrKelly Engineering is an industry leader experiencing dynamic growth in the Indianapolis, IN area, seeking a Project Manager- Commissioning & Qualification. This role is responsible for managing and executing commissioning and qualification activities for major pharmaceutical manufacturing projects, ensuring compliance with regulatory standards and providing technical leadership to cross-functional teams.
Staffing & Recruiting
Hiring Manager
Ammie Devenney
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
Qualification
Required
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
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
Founded in 1946
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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