Commissioning Manager

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, support project delivery excellence, and provide technical leadership to cross‑functional teams.

C&Q Project Managers are accountable for delivering qualified systems ready for GMP operation. The 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 are based in Lebanon, IN with additional time at the Indianapolis office as needed.

The Commissioning & Qualification (C&Q) Project Managers are responsible for managing and executing commissioning and qualification activities for major pharmaceutical manufacturing projects. These roles ensure compliance with regulatory and industry standards, support project delivery excellence, and provide technical leadership to cross‑functional teams.

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• 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.

• 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.

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