Lead Mechanical Supervisor – Pharma

Job Title: Lead Mechanical Supervisor – Pharma (Sterile / Utilities)Location: Fall River, MA (On-site)About The RoleWe 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 ResponsibilitiesLead end-to-end mechanical engineering projects (design → execution → qualification → close-out)Manage pharma utility systems: HVAC, cleanroom, compressed air, chilled water, steamOversee equipment selection, installation, and optimizationExecute and review IQ/OQ/PQ validation activities for mechanical systemsEnsure compliance with cGMP, FDA, and regulatory standardsDrive CapEx projects: budgeting, vendor coordination, procurement, and executionCollaborate with Quality, Validation, Manufacturing, and Regulatory teamsSupport change control, risk assessment, and audit readinessPrepare and maintain technical and validation documentationTroubleshoot and improve plant systems and operational efficiencyMust-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 lifecycleProven experience managing CapEx projects and vendor coordinationGood to HavePMP certificationExperience with SAP and project management tools (MS Project / Primavera)Exposure to audit preparation and regulatory inspectionsSkills: validation,manufacturing,hvac