Senior C&Q Project Engineer

About the role

Support a high-visibility pharmaceutical/biotechnology project in Indianapolis.

Tasks

• Lead C&Q strategy, planning, scheduling, and execution for the assigned project node.
• Coordinate Factory Acceptance Testing (FAT), documentation development, and test execution.
• Oversee pre-commissioning activities, punch-list management, and closeout.
• Manage C&Q service providers and ensure alignment with project objectives and timelines.
• Coordinate construction turnover and commissioning interfaces.
• Support change management, operational readiness, and final system handovers.
• Monitor progress, resolve execution challenges, and provide regular updates to program leadership.
• Ensure compliance with applicable pharmaceutical regulations, quality standards, and project procedures.

Requirements

• 10+ years of Commissioning & Qualification (C&Q/CQV) experience, preferably within pharmaceutical or biotechnology manufacturing.
• Bachelor’s degree in Engineering, Science, or a related discipline.
• Strong knowledge of pharmaceutical regulatory requirements and qualification practices.
• Proven experience managing multiple C&Q service providers simultaneously.
• Demonstrated ability to independently lead project activities and drive deliverables to completion.
• Willingness to work on-site in Indianapolis.
• Full PPE requirements.
• Experience delivering large-scale capital projects valued at $100M+ (preferred).
• Active Pharmaceutical Ingredient (API) manufacturing experience (preferred).
• Familiarity with electronic qualification platforms such as Kneat (preferred).
• Knowledge of 21 CF (preferred).

Schedule

• Early-morning meetings.

Location

• Indianapolis, Indiana