Job DescriptionJob Description
Overview:
We are seeking an experienced Commissioning Manager to oversee commissioning activities for complex projects in the Life Sciences and regulated industries. This role will lead commissioning efforts from early planning through facility turnover, ensuring that systems meet quality, regulatory, and operational requirements. The ideal candidate is a strong communicator and leader with a track record of delivering projects in GMP-regulated environments on time and within scope.
Responsibilities:
* Develop and execute project-specific commissioning plans in alignment with client requirements.
* Lead and coordinate internal and external Commissioning, Qualification, and Validation (CQV) resources.
* Oversee and review commissioning strategies, documentation, and test protocols.
* Witness and verify testing, including FAT, SAT, and site start-up activities.
* Collaborate with project teams, contractors, and vendors to resolve technical and schedule challenges.
* Apply risk-based approaches to commissioning and quality oversight.
* Ensure compliance with relevant regulatory standards, including FDA, EMEA, cGMP, and ISO requirements.
* Monitor asset performance during start-up and coordinate corrective actions as needed.
* Mentor and train project team members on commissioning best practices.
* Track and report commissioning progress to stakeholders.
Qualifications:
* Bachelor's degree in Engineering, Architecture, Construction Management, or related field (or equivalent experience).
* 5–10+ years of commissioning experience in Life Sciences, pharmaceuticals, or other regulated industries.
* Strong working knowledge of cGMP, FDA (21 CFR 210/211), and international regulatory requirements.
* Hands-on experience with commissioning building systems, utilities, and process equipment.
* Ability to read, interpret, and mark up technical drawings and specifications.
* Proficient with risk assessment and process improvement tools.
* Excellent organizational, interpersonal, and presentation skills.
* Willingness to travel as project needs require.
Key Words: CQV, Commissioning Manager, Life Sciences, Pharmaceutical Manufacturing, GMP, FAT, SAT, Validation, Clean Utilities, Process Equipment
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