Deputy Commissioning Manager – Pharmaceutical Facility / Industry
Houston Texas Based
On site or Hybrid
Role Overview
As Deputy Commissioning Manager, you’ll support the Commissioning Manager in planning and executing all Commissioning, Qualification, and Validation (CQV) activities for a cGMP pharmaceutical manufacturing facility. You’ll help ensure systems are commissioned safely, documented thoroughly, and transitioned smoothly into Qualification and Validation.
You’ll work closely with Engineering, Construction, Operations, Quality, Validation, and Project Management to keep the project moving and maintain alignment from Mechanical Completion through startup.
Key Responsibilities
- Assist in developing commissioning strategies, procedures, and execution plans.
- Coordinate daily commissioning activities across mechanical, electrical, controls, utilities, automation, and process systems.
- Lead discipline engineers and commissioning teams to meet safety and startup milestones.
- Support commissioning schedules, resource planning, and turnover priorities.
- Run commissioning meetings and provide clear status updates.
CQV Alignment
- Keep commissioning and CQV activities aligned throughout the project.
- Support turnover strategies between Construction, Commissioning, CQV, and Operations.
- Ensure commissioning documentation supports Qualification requirements and avoids duplicate testing.
- Work with Validation teams to meet regulatory expectations.
cGMP Compliance
- Ensure commissioning activities comply with:
- FDA cGMP
- EU GMP
- ISPE Baseline Guides
- GAMP 5
- Good Documentation Practices
System Turnover & Mechanical Completion
- Support development of system boundaries, turnover packages, and mechanical completion documentation.
- Develop commissioning plans, test scripts, energization plans, and acceptance criteria.
- Interpret P&IDs, control schematics, and project specifications.
- Work with engineering, construction, QA/QC, vendors, and owners to resolve technical issues.
Qualifications
Education & Experience
- Bachelor’s degree in Engineering, Construction Management, or related field (PE preferred).
- 10+ years in industrial commissioning, startup, CQV, or facility operations.
- 5+ years in pharmaceutical, biotech, life sciences, or regulated manufacturing.
- Experience supporting large capital projects ($200M+ preferred).
- Strong background in commissioning through qualification and operational readiness.
Technical Strengths
- cGMP regulations
- FDA & EU GMP
- ISPE Baseline Guides
- GAMP 5
- CQV methodologies
- Mechanical completion & turnover management