Job description:

Position Title: Pharmaceutical Maintenance Engineer

Department: Engineering / Facility Maintenance

Reports To: Head of Engineering / Plant Maintenance Manager

Industry: Pharmaceutical Manufacturing (cGMP Environment)

The Pharmaceutical Maintenance Engineer ensures the continuous, reliable, and compliant operation of all production, packaging, and utility systems within a pharmaceutical manufacturing facility. This role is critical in maintaining compliance with current Good Manufacturing Practices (cGMP), current Good Documentation Practices (cGDP), and regulatory standards (such as USFDA, WHO-GMP, and MHRA) to prevent downtime and safeguard product quality, safety, and efficacy.

Key Responsibilities1. Equipment Reliability & Maintenance Operations

- Preventive & Predictive Maintenance (PPM): Develop, schedule, and execute comprehensive PPM routines for critical manufacturing equipment (e.g., granulation lines, tablet compression machines, coating pans, blister packing machines, liquid filling lines).
- Breakdown Maintenance: Provide rapid response troubleshooting and root cause analysis (RCA) for mechanical, electrical, pneumatic, and hydraulic equipment failures to minimize line downtime.
- Spare Parts Management: Monitor critical spare parts inventory, establish minimum/maximum stock levels, and coordinate with procurement for timely replacement of wear-and-tear components.

2. Utilities & Facility Maintenance

- Critical Utilities Support: Oversee the upkeep and monitoring of critical plant utilities, including Purified Water (PW) systems,



Water for Injection (WFI), Clean Steam generators, Compressed Air systems, and Heating, Ventilation, and Air Conditioning (HVAC) systems with HEPA filtration.
- Environmental Controls: Ensure cleanroom pressure differentials, temperature, and relative humidity remain within validated operational thresholds.

3. Compliance, Validation & Documentation

- cGMP & Regulatory Compliance: Ensure all maintenance activities adhere strictly to internal standard operating procedures (SOPs) and international regulatory compliance frameworks.
- Equipment Qualification & Validation: Participate in installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for current or modified equipment.
- Documentation Excellence: Maintain accurate equipment history logs, logbooks, and work orders in compliance with cGDP. Author and execute Equipment Change Controls, Deviations, and Corrective and Preventive Actions (CAPAs).

4. Safety & Continuous Improvement

- EHS Compliance: Enforce strict adherence to environmental, health, and safety (EHS) policies, including Lockout/Tagout (LOTO), confined space entry, and hot work permits.
- Reliability Engineering: Drive continuous improvement initiatives, Equipment OEE (Overall Equipment Effectiveness) enhancements, and energy-saving projects.

Job Type: Full-time

Pay: ₹8,086.00 - ₹38,388.31 per month

Education:

- Secondary(10th Pass) (Preferred)

Experience:

- total work: 1 year (Preferred)

Work Location: In person

📌 Maintenance Engineer (Palakkad)
🏢 Kernovo Pharmaceutical Industries
📍 Palakkad