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.
- 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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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