We are seeking a Deputy Commissioning Manager to support the planning, coordination, and execution of Commissioning, Qualification, and Validation activities for a pharmaceutical manufacturing facility. This role will help ensure systems are safely commissioned, properly documented, and transitioned through Qualification, Validation, and Operational Readiness in compliance with regulatory and project requirements.
Key Responsibilities:
- Support the Commissioning Manager in developing and executing commissioning strategies, plans, schedules, and procedures.
- Coordinate multidisciplinary commissioning activities across mechanical, electrical, instrumentation, controls, utilities, HVAC, and automation systems.
- Lead commissioning teams and coordinate with Engineering, Construction, QA/QC, CQV, Operations, vendors, and client representatives.
- Support system turnover from Construction through Commissioning, CQV, and Operations, including Mechanical Completion Packages and Turnover Packages.
- Ensure commissioning activities and documentation align with CQV requirements and minimize duplicate testing and rework.
- Develop and review commissioning test procedures, checklists, acceptance criteria, and energization plans.
- Ensure compliance with FDA/EU cGMP, ISPE, GAMP 5, and Good Documentation Practices.
- Review drawings, P&IDs, control schematics, and project specifications to support commissioning activities.
- Facilitate commissioning meetings, track progress, resolve technical issues, and provide project status updates.
- Support operational readiness and successful facility startup.
Qualifications:
- Bachelor’s degree in Engineering, Construction Management, or a related technical discipline; PE preferred.
- 10+ years of industrial commissioning, startup, CQV, or facility operations experience.
- 5+ years of experience in pharmaceutical, biotechnology, life sciences, or other regulated manufacturing environments.
- Experience with large capital projects, preferably $200M+.
- Strong knowledge of cGMP, FDA/EU GMP, ISPE Baseline Guides, GAMP 5, CQV methodologies, mechanical completion, and turnover processes.
- Experience with process utilities, HVAC, BMS, and EMS systems.
- Strong leadership, communication, problem-solving, and stakeholder management skills.
- Demonstrated ability to work effectively across multidisciplinary teams from commissioning through operational readiness.
About Us
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services. Join us today.