Sr.Manager- Engineering For Pharma Formulation(EU & GMP Appr. Plant)

Veko Care; Karegaon; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Veko Care is seeking a seasoned Engineering & Maintenance leader for its pharmaceutical formulation facility. The role oversees the complete maintenance spectrum across equipment, HVAC, utilities, and process systems, ensuring high availability and regulatory readiness.

The candidate will drive preventive, predictive, and corrective maintenance, manage calibration and validation activities, and coordinate with QA, EHS, and operations to sustain compliant plant operations.

Qualifications

• Experience in pharmaceutical formulation/manufacturing plant.
• Hands-on maintenance in electrical & mechanical, HVAC O&M.
• Capability in calibration, qualification, and validation activities.
• Strong knowledge of cGMP/GEP, CAPA, and project management.

Responsibilities

• Lead the Engineering & Maintenance function for the facility.
• Plan and execute preventive, predictive, breakdown, and corrective maintenance.
• Ensure equipment availability and minimise downtime.
• Oversee HVAC and AHU operation, monitoring critical parameters.
• Supervise utility systems and electrical distribution.
• Coordinate qualification/validation protocols and reports.
• Drive GMP compliance and timely audit readiness.

Skills

Electrical

Mechanical

HVAC

Automation

Calibration

Validation

QMS/CMMS

AutoCAD

Project management

GMP/cGMP

Tools

AutoCAD

MS Office

CMMS

QMS software

Job description

Job Description

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

• 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 new 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.