Commissioning Manager Job Listing at Kelly Services in Indianapolis, IN (Job ID 10120765)

Description

Commissioning Manager (Indianapolis, IN)
Our client, a leader in the Pharmaceutical industry, is currently hiring several Commissioning Managers (Qualification (C&Q) Project Managers), Direct Hire; the Commissioning Managers will be responsible for executing commissioning and qualification activities for major pharmaceutical manufacturing projects. These roles ensure compliance with regulatory and industry standards, supports project delivery excellence, and provides technical leadership to cross-functional teams

Position Context: C&Q Project Managers are accountable for delivering qualified systems ready for GMP operation. Role requires close coordination with project engineering, operations, and quality functions. Travel may be required for Factory Acceptance Testing (FAT) and vendor site support. Full-time, on-site roles based in Lebanon, IN with additional time at the Indianapolis office as needed.

Role Purpose: The Commissioning & Qualification (C&Q) Project Managers are responsible for managing and executing commissioning and qualification activities for major pharmaceutical manufacturing projects. These roles ensures compliance with regulatory and industry standards, supports project delivery excellence, and provides technical leadership to cross-functional teams. The C&Q Project Managers act as subject matter experts, overseeing planning, execution, and documentation to enable successful facility startup and sustained operations.

Core Responsibilities:C&Q Planning & Execution - Lead all C&Q activities across assigned systems, equipment, and facilities.
Ensure compliance with GMP, FDA, and industry standards throughout all project phases.
Develop project-specific validation approaches consistent with client and ACE requirements.

Documentation & Compliance- Prepare, review, and approve C&Q deliverables, including Project Validation Plans, User Requirements, IV/OV test plans, and summary reports.
Ensure all documentation meets regulatory expectations and project standards.
Maintain traceability and alignment of requirements, testing, and acceptance criteria.

Test Execution- Oversee and perform Installation Verification (IV) and Operational Verification (OV) testing.
Ensure test protocols are executed accurately and deviations are resolved appropriately.
Validate that systems are qualified and ready for operational use.

Team Leadership & Development- Provide technical guidance and mentorship to C&Q engineers and junior staff.
Build capability within the project team through knowledge sharing and coaching.
Promote culture of quality, safety, and accountability.

Continuous Improvement- Identify opportunities for process improvement within commissioning and qualification activities.
Recommend and implement solutions that improve efficiency and compliance.
Stay current with regulatory changes and industry best practices.

Stakeholder Engagement- Collaborate with equipment vendors, contractors, and client representatives to ensure smooth project execution.
Act as a key point of contact for C&Q scope within assigned systems.
Escalate issues proactively and drive timely resolution with stakeholders.

Key Competencies: Strong understanding of commissioning, qualification, and validation methodologies.
Analytical problem-solver with attention to detail and regulatory compliance.
Effective communicator able to influence across disciplines and levels.
Organized and adaptable, with proven ability to manage competing priorities.
Leadership presence with capability to guide technical teams.

Qualifications: Minimum of 5 years of experience in commissioning and qualification within pharmaceutical, biotech, chemical, or related industries.
Bachelor's degree in Engineering, Life Sciences, or related field (advanced degree preferred).
Demonstrated experience leading large-scale C&Q efforts and cross-functional project teams.
Familiarity with GMP, FDA, EMA, and ISPE guidelines; strong working knowledge of ASTM E2500 and risk-based verification approaches.
Proficiency in project and validation management tools (e.g., Kneat, Smartsheet, or equivalent).

Employees here will enjoy the stability and reputation of a global industry leader, making it an ideal environment for advancing their careers and contributing to impactful healthcare solutions- Working here means joining a team at the forefront of pharmaceutical innovation and technology, with access to world-class resources and professional development opportunities.

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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