21 Aug
|
East India Pharmaceutical Works
|
Kolkata
21 Aug
East India Pharmaceutical Works
Kolkata
Job Description / Responsibility
Perform preventive, predictive and breakdown maintenance of equipment, troubleshoot issues and maintain safety and reliability standards.
Desired Profile of the Candidate
- Utilities & Engineering Management - Ensure smooth, continuous, and compliant operation of all plant utilities such as HVAC, boilers, chillers, purified water, compressed air, nitrogen and power distribution to support manufacturing activities.
- Maintenance of Critical Systems - Maintain utilities and equipment supporting OSD and liquid manufacturing areas, while monitoring parameters, trends, alarms, and deviations to protect product quality and regulatory compliance.
- Preventive & Predictive Maintenance - Plan and implement preventive and predictive maintenance programs to minimize breakdowns and downtime, including root cause analysis (RCA) and CAPA for recurring issues.
- Regulatory Compliance & Audit Support - Ensure all engineering activities comply with cGMP, WHO, and local regulatory requirements,
and actively support internal and external audits with proper documentation and technical justification.
- Documentation & Validation - Prepare, review, and execute engineering and validation documents such as SOPs, URS, DQ, IQ, OQ, PQ, change controls, deviations, risk assessments, and qualification/requalification protocols.
- Equipment & Facility Maintenance - Maintain manufacturing equipment and GMP-compliant facility infrastructure, including cleanrooms, AHUs, piping, drains, flooring, lighting, and building systems.
- Project Execution & Upgrades - Lead engineering projects such as recent installations, expansions, and energy-saving initiatives, coordinating with vendors and contractors to ensure GMP, safety, URS, and timeline compliance.
- Safety, Cost & Resource Management - Ensure SHE and statutory compliance, conduct risk assessments, manage engineering budgets, optimize energy usage, and oversee spare parts and AMC contracts.
📌 Maintenance Engineer (Kolkata)
🏢 East India Pharmaceutical Works
📍 Kolkata