Program Lead - Commissioning and Qualification, Pharmaceutical Manufacturing

About the role

We are seeking an experienced Commissioning & Qualification (C&Q) Program Lead to provide end-to-end leadership for the commissioning, qualification, and startup activities supporting the Central Utility Building (CUB) and Tank Farm & Solvent Recovery (TFSR) programs. This individual will serve as the owner's representative and single point of accountability for all CQV strategy, contractor oversight, execution planning, risk management, and handover activities to ensure facilities are delivered safely, compliantly, and on schedule.

Key Responsibilities

• Program Leadership
• CQV Execution & Contractor Management
• Schedule, Risk & Project Controls
• Construction Turnover & Startup Readiness
• Quality & Compliance
• Resource & Budget Management

Required Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, or related discipline)
• 15+ years of Commissioning, Qualification, Validation, and Startup experience within pharmaceutical or regulated manufacturing environments
• Demonstrated success leading CQV programs on large capital projects
• Strong understanding of ASTM E2500, GMP requirements, and risk-based commissioning methodologies
• Experience managing CQV contractors, vendors, and multidisciplinary project teams
• Proven expertise with qualification lifecycle execution, including MC, IV, OQ, PQ, and turnover processes
• Strong schedule management, risk management, and organizational leadership skills
• Excellent written and verbal communication abilities

Preferred Qualifications

• Experience with Central Utility Buildings (CUBs), clean utilities, HVAC, and site infrastructure systems
• Experience supporting solvent storage, tank farms, recovery, and distillation systems
• Previous experience on large-scale pharmaceutical greenfield projects
• Owner-side CQV leadership experience highly preferred