Job Description

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

• Bachelor's 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

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