Maintenance Head

Role & Responsibilities

• Lead and manage the Engineering & Maintenance function for the Injectable Manufacturing Plant.
• Ensure high availability, reliability, and optimum performance of all production, utility, and facility equipment.
• Plan and execute preventive, predictive, and breakdown maintenance activities to minimize equipment downtime.
• Manage maintenance of critical pharmaceutical utilities such as HVAC, AHU, purified water systems, WFI systems, compressed air, boilers, chillers, DG sets, electrical systems, and other plant utilities.
• Ensure proper maintenance and qualification support for cleanrooms, sterile areas, and critical manufacturing facilities.
• Develop and implement annual maintenance plans, shutdown plans, spare-parts planning, and maintenance budgets.
• Ensure compliance with cGMP, Schedule M, WHO-GMP, and other applicable regulatory requirements.
• Maintain complete and accurate engineering documentation, including SOPs, preventive maintenance records, breakdown reports, logbooks, equipment history cards, and calibration/qualification records.
• Lead investigations related to equipment failures, recurring breakdowns, deviations, and maintenance-related incidents, including Root Cause Analysis (RCA) and CAPA.
• Support equipment qualification, validation, commissioning, and requalification activities.
• Coordinate with Production, Quality Assurance, Quality Control, Validation, EHS, and other departments to ensure smooth plant operations.
• Manage external contractors and service providers for specialized maintenance and engineering activities.
• Ensure adequate availability and control of critical engineering spares and consumables.
• Identify opportunities for energy conservation, cost reduction, equipment improvement, and plant reliability enhancement.
• Lead and develop the engineering team through training, performance management, and technical capability building.
• Ensure compliance with EHS requirements, electrical safety, statutory inspections, and legal requirements.
• Participate in regulatory inspections and customer audits and provide appropriate engineering-related responses and corrective actions.
• Drive continuous improvement initiatives such as TPM, reliability improvement, OEE enhancement, and preventive maintenance optimization.
• Prepare and review engineering MIS, maintenance KPIs, downtime reports, utility consumption, and departmental performance reports.
• Ensure emergency preparedness and quick response to critical equipment and utility failures to avoid production interruptions.

Preferred Candidate Profile

• Bachelor's degree in Mechanical / Electrical / Instrumentation Engineering; postgraduate qualification will be an added advantage.
• 11+ years of relevant experience in Engineering & Maintenance, preferably in a pharmaceutical Injectable / Sterile manufacturing plant.
• Strong hands-on experience in sterile/injectable plant utilities, HVAC, cleanrooms, WFI/PW systems, compressed air, electrical systems, and critical utilities.
• Strong knowledge of cGMP, WHO-GMP, Schedule M, qualification, validation, and regulatory compliance requirements.
• Proven experience in managing preventive, predictive, breakdown, and shutdown maintenance.
• Experience in handling regulatory inspections and customer audits.
• Strong leadership and people-management skills with the ability to lead a multidisciplinary engineering team.
• Good knowledge of RCA, CAPA, risk assessment, change control, deviation management, and engineering documentation.
• Strong analytical, troubleshooting, decision-making, and problem-solving skills.
• Experience in CAPEX projects, equipment installation, commissioning, and plant expansion will be an advantage.
• Strong communication and coordination skills with cross-functional teams.
• Candidates with strong experience in Injectable / Sterile Pharmaceutical Manufacturing Plants will be preferred.Role & responsibilities

Preferred Candidate Profile

• Bachelor's degree in Mechanical / Electrical / Instrumentation Engineering; postgraduate qualification will be an added advantage.
• 11+ years of relevant experience in Engineering & Maintenance, preferably in a pharmaceutical Injectable / Sterile manufacturing plant.
• Strong hands-on experience in sterile/injectable plant utilities, HVAC, cleanrooms, WFI/PW systems, compressed air, electrical systems, and critical utilities.
• Strong knowledge of cGMP, WHO-GMP, Schedule M, qualification, validation, and regulatory compliance requirements.
• Proven experience in managing preventive, predictive, breakdown, and shutdown maintenance.
• Experience in handling regulatory inspections and customer audits.
• Strong leadership and people-management skills with the ability to lead a multidisciplinary engineering team.
• Good knowledge of RCA, CAPA, risk assessment, change control, deviation management, and engineering documentation.
• Strong analytical, troubleshooting, decision-making, and problem-solving skills.
• Experience in CAPEX projects, equipment installation, commissioning, and plant expansion will be an advantage.
• Strong communication and coordination skills with cross-functional teams.
• Candidates with strong experience in Injectable / Sterile Pharmaceutical Manufacturing Plants will be preferred.