Roles & Responsibility:

1.ENGINEERING & MAINTENANCE MANAGEMENT

- Lead the complete Engineering & Maintenance function for the formulation manufacturing facility.
- Ensure effective preventive, predictive, breakdown, and corrective maintenance of plant machinery, production equipment, utilities, and infrastructure.
- Develop and implement annual, monthly, and weekly maintenance plans.
- Ensure maximum equipment availability and minimum production downtime.
- Monitor equipment performance, breakdown trends, MTBF, MTTR, and maintenance KPIs.
- Identify recurring equipment failures and implement long-term corrective and preventive measures.
- Ensure timely execution of periodic servicing, annual maintenance, overhauling, inspection, and maintenance activities.

2. PLANT MACHINERY & PROCESS EQUIPMENT

- Ensure operation and maintenance of pharmaceutical formulation and packing equipment.
- Provide technical support for electrical, mechanical, instrumentation, and automation-related issues.
- Ensure proper installation, commissioning, troubleshooting, and maintenance of process equipment.
- Maintain process piping, utility piping, pumps, valves, motors, gearboxes, tanks, and associated equipment.
- Ensure availability of critical spare parts and engineering consumables.

3. HVAC & AHU MANAGEMENT

- Ensure efficient operation and maintenance of HVAC and AHU systems for pharmaceutical manufacturing areas.
- Monitor temperature, relative humidity, pressure differential, airflow, and other critical HVAC parameters.
- Manage HVAC BMS operations, including monitoring, alarms, trends, and system performance.
- Ensure HVAC systems remain in a validated and compliant state.
- Coordinate HVAC qualification, requalification, preventive maintenance, and troubleshooting.
- Ensure continuous HVAC facility readiness for regulatory, customer, and internal audits.

4. UTILITY MANAGEMENT Ensure effective operation, maintenance, and performance monitoring of critical plant utilities, including:

- Chillers and chilled-water systems
- Cooling towers
- Boilers and steam systems
- Hot-water systems and pumps
- Air compressors and compressed-air systems
- Process and utility water systems
- ETP and associated equipment
- Fire-fighting systems and fire pump house




- Electrical distribution systems
- DG sets and power backup systems
- HVAC and AHU systems
- Other critical plant utilities

5. ELECTRICAL & MECHANICAL MAINTENANCE

- Manage electrical and mechanical maintenance activities across the plant.
- Ensure timely troubleshooting of electrical and mechanical breakdowns.
- Handle installation and commissioning of electrical and mechanical equipment.
- Ensure proper maintenance of motors, pumps, panels, MCCs, transformers, DG sets, compressors, and other equipment.
- Ensure preventive maintenance of electrical systems and critical machinery.
- Maintain high standards of equipment reliability and operational safety.

6. CALIBRATION, QUALIFICATION & VALIDATION

- Ensure timely calibration of critical instruments and measuring equipment.
- Lead preparation, review, execution, and approval of qualification and validation protocols and reports.
- Ensure DQ, IQ, OQ, PQ and requalification activities are completed as applicable.
- Coordinate HVAC qualification, utility qualification, equipment qualification, and area validation.
- Ensure calibration and qualification records are properly maintained and audit-ready.

7. GEP & cGMP COMPLIANCE

- Ensure all engineering activities comply with cGMP, GMP, GEP, SOPs, and pharmaceutical quality requirements.
- Execute and maintain engineering documentation as per Good Engineering Practices.
- Ensure engineering facilities and utilities remain in a state of continuous compliance.
- Support internal, customer, regulatory, and statutory audits.
- Ensure timely closure of engineering-related audit observations.

8. DOCUMENTATION & QMS

- Prepare and review engineering documentation, including:

- Qualification protocols and reports

- Validation documents

- Calibration records

- Preventive maintenance records

- Breakdown reports

- Change Controls

- Deviations

- CAPA





- Risk Assessments

- Engineering SOPs

- Project documentation

- GEP documents
- Use QMS software for engineering-related quality activities.
- Ensure proper documentation and timely closure of change controls, deviations, CAPAs, and other quality actions.

9. PROJECT MANAGEMENT & CAPEX

- Lead engineering projects including current equipment installation, plant expansion, facility modification, capacity enhancement, and utility projects.
- Plan and execute projects from design through installation, commissioning, qualification, and handover.
- Coordinate with vendors, consultants, contractors, Production, QA, QC, EHS, Procurement, and other departments.
- Prepare project schedules and monitor progress against agreed timelines.
- Ensure projects are completed safely, on time, and within approved budgets.

10. SAFETY & STATUTORY COMPLIANCE

- Ensure all maintenance and engineering activities are performed in accordance with site safety procedures.
- Ensure compliance with applicable EHS and statutory safety requirements.
- Conduct safety inspections of engineering areas and equipment.
- Ensure safe working practices during maintenance, installation, and project execution.
- Ensure contractors and maintenance personnel follow site safety procedures.
- Support emergency preparedness and fire-safety activities.

11. VENDOR & CONTRACTOR MANAGEMENT

- Manage AMC vendors, contractors, equipment suppliers, and service providers.
- Evaluate vendor performance and ensure timely completion of maintenance activities.
- Coordinate annual maintenance contracts and specialized engineering services.
- Ensure contractors follow quality, safety, and site compliance requirements.

Knowledge Required

- 1015 years of experience, preferably in a pharmaceutical formulation manufacturing plant.
- Hands-on experience in Electrical & Mechanical maintenance, installation, commissioning, calibration, troubleshooting, instrumentation, HVAC O&M; and area validation.
- Strong knowledge of pharmaceutical utilities, cGMP/GEP, qualification, validation, CAPA, project management and maintenance systems.
- Proficiency in AutoCAD, MS Office, Excel, e-mail/internet and QMS/CMMS software.

📌 Sr.Manager- Engineering For Pharma Formulation(EU & GMP Appr. Plant) (Pune)
🏢 Veko Care
📍 Pune