Maintenance Manager

Job Title: Maintenance Manager - API & Bulk Drug Manufacturing

Department: Maintenance / Engineering

Reports To: Head Engineering / Plant Head

Location: Raichur, Karnataka

Experience: 10 to 12 Years

Industry: Pharmaceutical (API / Bulk Drug Manufacturing)

Job Purpose:

To lead and manage the maintenance and engineering functions of the API/Bulk Drug manufacturing facility by ensuring the reliability, efficiency, and compliance of all plant equipment and utilities. Responsible for implementing preventive, predictive, and corrective maintenance systems aligned with cGMP, regulatory, and safety standards.

Key Responsibilities:

1. Preventive & Breakdown Maintenance

• Develop and oversee preventive and predictive maintenance programs for all process and utility equipment.
• Lead troubleshooting and root cause analysis (RCA) for critical breakdowns to reduce equipment downtime.
• Ensure minimal disruption to production operations through effective maintenance planning and execution.
• Monitor performance metrics such as MTBF (Mean Time Between Failures) and MTTR (Mean Time to Repair).

2. Equipment & Utility Management

• Ensure smooth operation and maintenance of key process equipment: reactors, centrifuges, dryers (FBD, RVD), filters, condensers, pumps, agitators, etc.
• Oversee operation and maintenance of utilities such as boilers, chillers, air compressors, cooling towers, HVAC, vacuum systems, nitrogen generation, water systems (RO, DM, Softener, Purified Water), and ETP/STP.
• Optimize energy usage and utility performance to reduce operational costs.

3. Compliance, Documentation & Audits

• Ensure all maintenance activities comply with cGMP, FDA, MHRA, WHO, and other regulatory guidelines.
• Prepare and maintain SOPs, calibration and maintenance records, equipment history cards, and logbooks.
• Support internal/external audits and ensure timely closure of CAPAs related to maintenance and engineering.
• Coordinate with QA/QC for equipment qualification (IQ/OQ/PQ) and requalification.

4. Project & Equipment Installation

• Plan and execute new equipment installation, commissioning, and validation activities.
• Participate in facility expansion, modification, and technology transfer projects.
• Evaluate and manage contractors, vendors, and service providers for project execution and AMC management.

5. Team Management & Training

• Lead, mentor, and develop a team of engineers, technicians, and operators.
• Conduct regular training on equipment handling, maintenance procedures, and safety practices.
• Foster a culture of proactive maintenance, safety, and continuous improvement within the team.

6. Safety & Regulatory Compliance

• Implement and monitor plant safety systems and ensure compliance with statutory and environmental regulations.
• Conduct risk assessments, HAZOP, and safety audits related to equipment and utilities.
• Promote zero-incident culture and ensure proper LOTO (Lockout/Tagout) implementation.

Key Skills & Competencies:

• Strong knowledge of mechanical, electrical, and instrumentation systems in API/Bulk Drug manufacturing.
• Sound understanding of GMP, GDP, and engineering documentation practices.
• Expertise in utility management and energy optimization.
• Experience in CMMS (SAP / Maximo / other maintenance systems).
• Excellent leadership, problem-solving, and analytical skills.
• Good communication and interdepartmental coordination.

Qualification:

• Education: B.E. / B.Tech in Mechanical / Electrical / Instrumentation / Industrial Engineering.
• Certifications (Preferred): Boiler operation, cGMP training, Energy Management, Six Sigma, or Maintenance Reliability.

Key Performance Indicators (KPIs):

• Equipment uptime and reliability (>95%).
• Reduction in unplanned breakdowns.
• Maintenance cost vs. budget compliance.
• Audit compliance (GMP/Regulatory).
• Utility efficiency and energy savings.
• Team skill development and safety performance.