Lead Mechanical Supervisor – Pharma
Umanist Staffing•Fall River, MA
•Onsite
About The Position
We are looking for a Lead Mechanical Supervisor to drive mechanical engineering and capital projects within a sterile pharmaceutical manufacturing environment. This role will lead utilities, equipment qualification, and facility upgrades, ensuring compliance with cGMP and regulatory standards.
Requirements
- Bachelor’s degree in Mechanical / Electrical Engineering (Master’s preferred)
- 5+ years of experience in pharmaceutical manufacturing (mandatory)
- Hands-on experience with pharma utility systems (HVAC, cleanroom, compressed air, chilled water, steam)
- Must have worked in sterile injectables environment (vials / PFS / IV bags)
- Proven experience managing CapEx projects and vendor coordination
- Strong experience in IQ/OQ/PQ execution and validation lifecycle
Nice To Haves
- PMP certification
- Experience with SAP and project management tools (MS Project / Primavera)
- Exposure to audit preparation and regulatory inspections
Responsibilities
- Lead end-to-end mechanical engineering projects (design → execution → qualification → close-out)
- Manage pharma utility systems: HVAC, cleanroom, compressed air, chilled water, steam
- Oversee equipment selection, installation, and optimization
- Execute and review IQ/OQ/PQ validation activities for mechanical systems
- Ensure compliance with cGMP, FDA, and regulatory standards
- Drive CapEx projects: budgeting, vendor coordination, procurement, and execution
- Collaborate with Quality, Validation, Manufacturing, and Regulatory teams
- Support change control, risk assessment, and audit readiness
- Prepare and maintain technical and validation documentation
- Troubleshoot and improve plant systems and operational efficiency
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What This Job Offers
Job Type
Full-time
Career Level
Senior
