AGM / DGM – Overall Engineering (Injections – USFDA Approved Facility)

AGM / DGM – Overall Engineering (Injections – USFDA Approved Facility)Experience: 15+ YearsQualification: B.Tech (Mechanical) – Full TimeTeam Handling: 70+ Team Members🔧 Job SummaryWe are looking for an experienced Engineering Leader to head the overall engineering function at a USFDA-approved sterile injectable manufacturing facility. The candidate will be responsible for ensuring smooth plant operations, regulatory compliance, and leading a large engineering team across utilities, maintenance, projects, and validation.⚙️ Key ResponsibilitiesLead and manage overall engineering operations for injectable manufacturing (Sterile / Parenteral facility)Ensure compliance with USFDA, MHRA, EU GMP and other regulatory standardsHandle plant maintenance (preventive & breakdown) for all critical equipmentOversee utilities such as HVAC, Water Systems (PW/WFI), Boilers, Chillers, Compressed Air, etc.Manage engineering projects, including expansion, installation, and commissioning of new equipmentEnsure qualification & validation of equipment and utilities (IQ, OQ, PQ)Drive energy efficiency, cost optimization, and continuous improvement initiativesPrepare for and handle regulatory audits and inspectionsCoordinate with cross-functional teams – Production, QA, QC, EHSEnsure proper documentation, SOPs, and engineering compliance recordsLead, mentor, and develop a team of ~70 engineering professionals