Commissioning and Qualification Program Lead

15+ years developing and delivering C+Q programs for greenfield sites
Managing scope, budget, schedule, hiring, performance of C+Q teams
Connecting cross-functionally with different groups (quality, EPCM firms, subcontractors)
Coming from pharmaceutical build background

Job description

• Primary Responsibilities
• Provide strategic leadership for all C&Q activities, ensuring scope, timelines, and budgets are consistently met.
• Direct day‑to‑day performance of the C&Q team and offer technical guidance to support successful project delivery.
• Develop and oversee FAT planning, test case creation, and all field execution logistics.
• Partner closely with construction, automation, QA, project management, and end‑user groups to maintain alignment on system requirements and delivery expectations.
• Maintain adherence to GMPs, regulatory standards, internal procedures, and overall project safety practices.
• Lead training sessions for internal teams and external vendors on C&Q methodology, ASTM E2500 processes, and Kneat system usage.
• Coordinate the sourcing, readiness, and deployment of test equipment and field support resources.
• Communicate progress, risks, and performance metrics to project leadership with clarity and consistency.
• Drive timely escalation and resolution of technical issues to keep projects moving efficiently.

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• Qualifications
• Bachelor’s degree in Engineering or equivalent practical experience.
• 15+ years of experience delivering C&Q efforts for large pharmaceutical programs.
• Proven track record supporting full‑lifecycle delivery of both Greenfield and Brownfield facilities.
• Strong team‑building, leadership, and communication skills.
• Expertise in GMPs, regulatory frameworks, commissioning, qualification, and ASTM E2500 practices.
• Hands‑on proficiency with Kneat or similar electronic C&Q/validation platforms.