C&Q Lead (Commissioning & Qualification Lead)

Role Summary

The C&Q Lead is responsible for overseeing and executing commissioning qualification and validation (CQV) activities for manufacturing facilities utilities equipment and systems. This role ensures compliance with regulatory requirements and internal quality standards while supporting the successful delivery of capital projects and operational readiness.

This position requires full-time onsite presence in New Albany Ohio.

Key Responsibilities

• Lead end-to-end commissioning and qualification activities for new and existing systems including facilities utilities and process equipment
• Develop and execute C&Q strategies plans and protocols (IQ/OQ/PQ) aligned with regulatory expectations (e.g. FDA EMA)
• Collaborate cross-functionally with Engineering Quality Assurance Manufacturing and external vendors
• Ensure systems are designed installed tested and documented in compliance with GMP standards
• Review and approve technical documentation including URS FRS design specs and validation reports
• Manage risk assessments (e.g. FMEA impact assessments) to determine qualification scope
• Provide leadership and mentorship to C&Q engineers and contractors
• Track project timelines budgets and deliverables to ensure on-time project completion
• Support regulatory inspections and audits by providing C&Q documentation and SME expertise
• Drive continuous improvement initiatives related to validation processes and compliance

General Qualifications

• Bachelors degree in engineering Life Sciences or related field
• 8 years of experience in commissioning qualification and validation within the pharmaceutical or biotechnology industry
• Strong knowledge of GMP regulations and industry standards (e.g. ISPE ASTM E2500)
• Experience with large-scale capital projects or facility start-ups
• Demonstrated leadership experience managing teams or projects

Preferred Qualifications

• Experience in sterile manufacturing biologics or drug substance/drug product facilities
• Familiarity with automation systems (DeltaV SCADA PLCs)
• Strong problem-solving communication and organizational skills
• Ability to manage multiple priorities in a fast-paced environment
• Project Management certification (PMP) is a plus