Assistant Manager – Engineering
1 week ago
Department: Engineering & Maintenance
Location: Dahej SEZ 2
Experience Required: 8- 12 years (Pharma Engineering OSD & SVP)
Key Responsibilities:
- Lead and supervise engineering operations and maintenance activities for both OSD (Oral Solid Dosage) and SVP (Small Volume Parenterals) facilities.
- Ensure availability, reliability, and optimal performance of all production equipment, utilities, and support systems.
- Plan and execute preventive and breakdown maintenance schedules for critical equipment (Granulators, Compressors, FBDs, Autoclaves, Vial/Ampoule filling machines, HVAC, Water systems, etc.).
- Oversee qualification, validation, and calibration of equipment and utilities in compliance with cGMP requirements.
- Ensure uninterrupted operation of critical utilities (HVAC, purified water, WFI, clean steam, compressed air).
- Coordinate with Production, QA, and Projects teams to support smooth manufacturing operations.
- Implement energy-saving initiatives, cost control, and efficiency improvement projects .
- Ensure compliance with GMP, safety, and statutory requirements during all engineering activities.
- Manage and guide the engineering team; ensure proper training and skill development.
- Prepare documentation related to SOPs, maintenance records, change controls, deviations, and CAPAs .
- Provide support during regulatory audits and inspections (USFDA, MHRA, WHO, etc.) .
Desired Candidate Profile:
- B.E. B.Tech (Mechanical Electrical Instrumentation) or equivalent.
- 8 -12 years of relevant experience in Engineering & Maintenance within OSD and SVP pharma plants.
- Strong knowledge of GMP requirements, cleanroom HVAC systems, sterile utilities, and pharma equipment .
- Experience in handling regulatory audits and compliance activities.
- Strong leadership, problem-solving, and communication skills.
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