Deputy General Manager -Engineering (API)

1. Job Purpose

To lead the Engineering, Maintenance, Utilities, Projects and Reliability functions of an Active Pharmaceutical Ingredient (API) manufacturing plant, ensuring uninterrupted production, equipment reliability, regulatory compliance, safety, energy efficiency and cost optimization in accordance with cGMP and applicable pharmaceutical regulations.

2. Key Responsibilities

A. Engineering & Maintenance

• Lead preventive, predictive and breakdown maintenance of all production equipment and plant machinery.
• Ensure reliable operation of reactors, centrifuges, dryers, filters, condensers, pumps, agitators, heat exchangers and other process equipment.
• Develop annual maintenance plans, shutdown schedules and equipment replacement strategies.
• Minimize equipment downtime and improve Overall Equipment Effectiveness (OEE).
• Establish equipment criticality assessments and reliability improvement programs.
• Manage spare parts inventory, critical spares and maintenance budgets.

B. Utilities Management

• Ensure uninterrupted supply and efficient operation of:
  
• Boilers and thermic fluid heating systems.
• Chillers, cooling towers and chilled water systems.
• Air compressors and instrument air systems.
• HVAC and ventilation systems.
• Water treatment, purified water and process water systems, where applicable.
• Effluent treatment plant (ETP) and solvent recovery systems.
• Nitrogen, vacuum and other process utility systems.
• Monitor utility consumption and implement energy-saving initiatives.
• Ensure statutory inspections and compliance for applicable utility equipment.

C. Projects & Capital Expenditure (CAPEX)

• Plan and execute plant expansion, equipment installation and modernization projects.
• Prepare technical specifications, cost estimates and capital expenditure proposals.
• Coordinate with consultants, contractors, vendors and cross-functional teams.
• Supervise equipment erection, installation, commissioning and qualification.
• Ensure timely project completion within approved budgets and safety requirements.

D. cGMP, Quality & Regulatory Compliance

• Ensure engineering activities comply with applicable cGMP requirements and site quality procedures.
• Support equipment qualification, including IQ/OQ/PQ, as applicable.
• Maintain engineering SOPs, preventive maintenance records, calibration records and equipment history files.
• Participate in internal audits, customer audits and regulatory inspections.
• Support deviation investigations, root cause analysis, CAPA and change control.
• Ensure proper documentation and engineering controls for critical process equipment and utilities.

E. Safety, Health & Environment (EHS)

• Ensure compliance with applicable factory, electrical, boiler, fire safety and environmental regulations.
• Implement permit-to-work, lockout/tagout (LOTO), confined-space entry and hot-work safety procedures.
• Support process safety reviews, HAZOP recommendations and risk assessments.
• Ensure safe handling and containment of solvents, chemicals and hazardous process materials.
• Coordinate with EHS for incident investigations and corrective actions.

F. Team & Budget Management

• Lead engineering, maintenance, utilities, instrumentation and project teams.
• Develop manpower plans, training programs and technical competency assessments.
• Monitor engineering KPIs, maintenance costs and utility expenses.
• Manage annual operating expenditure (OPEX) and CAPEX budgets.
• Drive continuous improvement, equipment reliability and operational excellence.

3. Educational Qualifications

• B.E./B.Tech. in Mechanical, Electrical, Chemical or Instrumentation Engineering.
• Relevant postgraduate qualification or management certification is an advantage.
• Knowledge of pharmaceutical API manufacturing processes and cGMP engineering requirements is essential.

4. Experience Required

• Typically 1220 years of experience in engineering and maintenance within pharmaceutical API, bulk drug, specialty chemical or process manufacturing plants.
• At least 5 years in a senior engineering leadership or plant engineering management role is preferred.
• Experience in plant utilities, process equipment, maintenance management, CAPEX projects and regulatory audits.
• Experience with greenfield or brownfield projects is an added advantage.

The experience range can be adjusted depending on whether the position is Engineering Head, DGM or GM.

5. Key Performance Indicators (KPIs)

KPI

Expected focus

Equipment availability

Maximize plant and equipment uptime

Breakdown frequency

Reduce unplanned maintenance

Preventive maintenance

Achieve timely PM completion

Utility consumption

Reduce energy and utility costs

Maintenance expenditure

Control OPEX and spare parts costs

Project execution

Complete projects on time and within budget

Compliance

Close audit observations and CAPAs on time

Safety

Reduce engineering-related incidents

Equipment qualification

Complete applicable qualification activities on schedule

6. Technical Skills Required

• API process equipment and chemical plant engineering.
• Preventive and predictive maintenance systems.
• Utility system operation and troubleshooting.
• cGMP, equipment qualification, change control and CAPA.
• Root cause analysis (RCA), FMEA and reliability engineering.
• Project management, vendor development and contract management.
• CMMS/SAP Plant Maintenance and engineering documentation.
• Energy conservation, process safety and statutory compliance.

7. Reporting Structure

• Reports to: Plant Head / Site Head / Director – Operations.
• Direct reports: Maintenance Manager, Utilities Manager, Projects Manager, Instrumentation/Automation Manager and Engineering Supervisors, depending on plant structure.
• Key interfaces: Production, Quality Assurance, Quality Control, EHS, Validation, Supply Chain and Finance.