C&Q Program Lead

QCS Staffing; Kentucky; On-site; USD 120,000 - 170,000; Full time

Job summary

QCS Staffing seeks a C&Q Program Lead for an Ohio capital project. You will lead the C&Q strategy, coordinate multiple CQV teams, and ensure GMP, GEP, and ASTM E2500 compliance across planning, documentation, and qualification phases.

Interfaces with Engineering, Construction Management, and Site Operations to manage contractors, milestones, and risks, delivering complete, compliant turnover packages on schedule.

Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, or related) or equivalent.
• Extensive experience in commissioning & qualification / startup within pharmaceutical, API, or regulated manufacturing.
• Experience in a lead capacity managing major capital construction projects valued between $500 million and $2 billion
• Demonstrated experience leading C&Q programs on capital projects and managing execution contractors.
• Knowledge of utilities and/or solvent / tank farm systems strongly preferred.
• Risk-based C&Q (ASTM E2500 / GEP) and GMP requirements for utilities and bulk chemical systems.
• Clean utilities (WFI, clean steam, PW), HVAC, black utilities, and/or bulk solvent storage, distribution, and recovery.

Responsibilities

• Lead the overall C&Q programme strategy and execution, ensuring alignment with quality, safety, and project objectives.
• Act as the primary C&Q representative, coordinating multiple CQV teams from planning and documentation through to qualification and project handover.
• Oversee C&Q contractors, managing scope, deliverables, performance, and successful programme delivery.
• Own key C&Q milestones, schedules, and risks, driving mitigation plans to maintain project timelines.
• Lead cross-functional collaboration between Engineering, Construction Management, CQV teams, Project Leadership, and Site Operations stakeholders.
• Ensure all commissioning and qualification activities comply with GMP, GEP, ASTM E2500, and site quality standards while maintaining inspection readiness.
• Manage mechanical completion and construction turnover activities, ensuring systems are handed over efficiently with complete and compliant documentation.

Skills

Leadership

CQV program management

GMP/GEP knowledge

Risk assessment

Cross-functional collaboration

Contractor management

Capital project execution

Education

Engineering degree or equivalent

Engineering degree (Chemical, Mechanical) or related

Job description

C&Q Program Lead - Ohio - 12 months

Be part of a next-generation pharmaceutical project that’s transforming how medicines are made.

What You’ll Deliver

• Lead the overall C&Q programme strategy and execution, ensuring alignment with quality, safety, and project objectives.


• Act as the primary C&Q representative, coordinating multiple CQV teams from planning and documentation through to qualification and project handover.


• Oversee C&Q contractors, managing scope, deliverables, performance, and successful programme delivery.


• Own key C&Q milestones, schedules, and risks, driving mitigation plans to maintain project timelines.


• Lead cross-functional collaboration between Engineering, Construction Management, CQV teams, Project Leadership, and Site Operations stakeholders.


• Ensure all commissioning and qualification activities comply with GMP, GEP, ASTM E2500, and site quality standards while maintaining inspection readiness.


• Manage mechanical completion and construction turnover activities, ensuring systems are handed over efficiently with complete and compliant documentation.

What You’ll Need

• Bachelor's degree in Engineering (Chemical, Mechanical, or related) or equivalent.


• Extensive experience in commissioning & qualification / startup within pharmaceutical, API, or regulated manufacturing.


• Experience in a lead capacity managing major capital construction projects valued between $500 million and $2 billion


• Demonstrated experience leading C&Q programs on capital projects and managing execution contractors.


• Knowledge of utilities and/or solvent / tank farm systems strongly preferred.


• Risk-based C&Q (ASTM E2500 / GEP) and GMP requirements for utilities and bulk chemical systems.


• Clean utilities (WFI, clean steam, PW), HVAC, black utilities, and/or bulk solvent storage, distribution, and recovery.