Maintenance Head

Saanso Pharma; Eluru District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Saanso Pharma seeks a senior Engineering & Maintenance leader for its Injectable Manufacturing Plant in India. You will oversee maintenance of production, utilities, and facility equipment ensuring high availability and regulatory compliance.

Lead preventive, predictive, and breakdown activities, and manage calibration, qualification, and documentation. You will drive TPM initiatives, energy efficiency, and CAPA/RCA processes while coordinating with QA, Validation, EHS, and external contractors

Qualifications

• 11+ years of relevant experience in Engineering & Maintenance in pharma injectable/sterile plants.
• Strong hands-on experience with sterile plant utilities (HVAC, WFI, PW), cleanrooms, and critical utilities.
• Proven ability to lead preventive, predictive, breakdown, and shutdown maintenance.
• Experience managing regulatory inspections and customer audits.

Responsibilities

• Lead and manage Engineering & Maintenance for the Injectable Manufacturing Plant.
• Plan and execute preventive, predictive, and breakdown maintenance to minimize downtime.
• Oversee utilities including HVAC, water systems, boilers, DG sets, and electrical systems.
• Develop annual maintenance plans, shutdown plans, spare-parts, and budgets.
• Ensure cGMP, Schedule M, WHO-GMP compliance and maintain engineering documentation.
• Lead RCA/CAPA investigations and support qualification, validation, and commissioning.
• Coordinate with Production, QA/QC, Validation, EHS, and other departments.

Skills

Maintenance leadership

Regulatory compliance

cGMP knowledge

RCA & CAPA

Cross-functional coordination

Education

Mechanical Engineering

Electrical Engineering

Instrumentation Engineering

Postgraduate qualification

Job description

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.

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.