Manager Engineering, Sterile or Injectable Plant,Goa
2 weeks ago
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Role & responsibilities
- Oversee preventive and breakdown maintenance of utilities, process equipment, HVAC, WFI, clean steam, and compressed air systems.
- Ensure reliable operation of sterile manufacturing equipment
- Prepare and implement preventive maintenance schedules for plants and equipment.
- Handle installation, qualification, and validation (IQ/OQ/PQ) of new equipment and systems.
- Coordinate with production, quality, and EHS departments to ensure GMP compliance.
- Maintain and monitor HVAC systems to meet cleanroom environmental conditions.
- Ensure all engineering documentation is in line with regulatory requirements (USFDA, MHRA, WHO-GMP, etc.).
- Manage energy conservation initiatives and utility cost optimization.
- Lead a team of engineers and technicians for smooth daily operations.
- Handle vendor management, procurement of spare parts, and annual maintenance contracts (AMCs).
- Support during internal and external audits by providing required engineering documentation.
Preferred candidate profile
To manage and ensure smooth functioning of all engineering and maintenance activities in the sterile/injectable manufacturing facility while maintaining compliance with regulatory requirements, safety standards, and production schedules.
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