Job Title: Lead Mechanical Supervisor – Pharma (Sterile / Utilities)

Location: Fall River, MA (On-site)

About The Role

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.

Key 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

Must-Have Requirements (Strict Screening)

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)
Strong experience in IQ/OQ/PQ execution and validation lifecycle
Proven experience managing CapEx projects and vendor coordination

Good to Have

PMP certification
Experience with SAP and project management tools (MS Project / Primavera)
Exposure to audit preparation and regulatory inspections

Skills: validation,manufacturing,hvac

Umanist NA

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Lead Mechanical Supervisor – Pharma