Program Lead - Commissioning and Qualification, Pharmaceutical Manufacturing

Job Type
Location
Indianapolis, Indiana
Salary
US$150 - US$165 per hour + *negotiable
Job Ref
BBBH2324953_1788198078
Date Added
August 31st, 2026
Consultant
rebecca schopfer

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.

The right candidate will have the following:

  • 15+ years of Commissioning & Qualification (C&Q) leadership experience within pharmaceutical, API, biotech, or other regulated manufacturing environments
  • Proven experience leading large-scale CQV programs on capital projects, including oversight of C&Q execution contractors, strategy development, execution planning, and program delivery.
  • Strong knowledge of risk-based C&Q methodologies and GMP requirements, including ASTM E2500, GEP, qualification lifecycle management, and inspection readiness
  • Technical expertise in utility and infrastructure systems, including clean utilities (WFI, Clean Steam, PW), HVAC, black utilities, compressed air, process gases, and/or bulk solvent storage, distribution, and recovery systems
  • Experience managing turnover, startup, and handover processes, including Mechanical Completion (MC), IV, OQ, PQ, turnover packages, documentation review, and system acceptance.

Long-term multi year contract.

Onsite: Indianapolis, IN

Rate: W2 or 1099; $150+ negotiable

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

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.

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