Maintenance Manager

Job Title: Maintenance Manager - API & Bulk Drug Manufacturing

• 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.