Position: Head – Engineering

Department: Engineering & Maintenance

Reporting To: Plant Head / Site Head / Director – Operations

Experience: 15–30 Years (preferred)

Qualification: B.E. / B.Tech in Mechanical / Electrical / Chemical Engineering

Industry: Pharmaceutical (Formulations / Injectables / API)

1. Job Purpose

To lead and manage the complete engineering, maintenance, utility and infrastructure operations of the pharmaceutical manufacturing facility, ensuring uninterrupted production, regulatory compliance, equipment reliability, energy efficiency and effective management of engineering projects.

The Engineering Head shall ensure that all engineering systems and utilities are designed, operated, maintained, qualified and validated in accordance with applicable GMP requirements and international regulatory standards.

2. Key Responsibilities A. Engineering Operations & Maintenance

- Overall responsibility for engineering and maintenance activities across the manufacturing facility.
- Ensure preventive, predictive and breakdown maintenance of all plant equipment and engineering systems.
- Develop and implement annual maintenance plans and equipment reliability programs.
- Ensure minimum equipment downtime and uninterrupted manufacturing operations.
- Establish SOPs, maintenance procedures, equipment history cards and maintenance records.
- Manage spare parts inventory and critical engineering spares.

B. Utility Management

Overall responsibility for the operation and maintenance of critical and non-critical utilities, including:

- HVAC systems, AHUs, HEPA filtration and cleanroom systems.
- Chilled water and cooling tower systems.
- Boiler, thermic fluid heater and hot water systems.
- Compressed air and instrument air systems.
- Nitrogen and other process gases.
- Purified Water (PW), RO and Water for Injection (WFI) systems, wherever applicable.
- Electrical distribution systems, transformers, DG sets and UPS.
- Firefighting and fire alarm systems.
- ETP, STP and other environmental management systems.

C. GMP & Regulatory Compliance

- Ensure engineering systems comply with applicable GMP requirements.
- Maintain engineering documentation in accordance with WHO-GMP, EU-GMP, US FDA and other applicable regulatory guidelines.
- Ensure qualification and validation of critical engineering systems (DQ, IQ, OQ and PQ).
- Review and approve engineering-related SOPs,



protocols, reports and logbooks.
- Handle engineering-related deviations, CAPA, change controls and investigations.
- Ensure compliance with data integrity and electronic documentation requirements, wherever applicable.
- Support regulatory inspections and customer audits.
- Ensure calibration and periodic requalification of critical equipment and utility systems.

D. Project Management & Current Installations

- Lead engineering projects related to plant expansion, modernization and capacity enhancement.
- Review engineering designs, equipment specifications, P&IDs;, layouts and technical drawings.
- Coordinate with consultants, architects, contractors and equipment suppliers.
- Ensure proper installation, commissioning, qualification and handover of new equipment and utilities.
- Monitor project budgets, timelines, resource allocation and execution quality.
- Ensure engineering modifications are implemented through an approved change control system.

E. Energy Management & Cost Optimization

- Develop energy conservation initiatives and utility cost reduction programs.
- Monitor consumption of electricity, water, steam, compressed air and other utilities.
- Optimize HVAC operations, equipment performance and utility generation.
- Implement energy-efficient technologies and sustainable engineering practices.
- Prepare and monitor annual engineering and maintenance budgets.

F. Team Management & Leadership

- Lead engineering, utility and maintenance teams.
- Define responsibilities and performance objectives for departmental personnel.
- Conduct technical training and competency development.
- Ensure adequate manpower planning and shift management.
- Coordinate with Production, QA, QC, EHS, Validation and Warehouse departments.
- Establish a strong safety, quality and accountability culture within the engineering department.

G. Safety & Statutory Compliance

- Ensure compliance with electrical safety, boiler regulations, fire safety and applicable statutory requirements.




- Ensure proper implementation of LOTO, work permits and contractor safety procedures.
- Conduct periodic safety inspections and risk assessments.
- Ensure safe operation of all plant machinery and utility installations.

3. Key Performance Indicators (KPIs)

KPI

Performance Parameter

Equipment uptime

Maximum equipment availability

Preventive maintenance

100% schedule compliance

Breakdown maintenance

Minimum breakdown frequency

Utility performance

Uninterrupted utility availability

GMP compliance

Zero critical engineering observations

Qualification

Timely completion of qualification activities

Energy management

Reduction in energy consumption

Budget management

Engineering expenditure within approved budget

Safety

Zero major safety incidents

Documentation

Timely completion of engineering records

4. Required Technical Competencies

The candidate should possess strong knowledge and practical experience in:

- Pharmaceutical HVAC and cleanroom engineering.
- Critical and non-critical pharmaceutical utilities.
- GMP engineering documentation and regulatory requirements.
- Preventive and predictive maintenance systems.
- Equipment qualification and validation.
- Electrical systems and utility distribution.
- Project execution and commissioning.
- Engineering budgeting and cost optimization.
- Risk assessment, deviation, CAPA and change control.
- EHS and statutory compliance.

5. Desired Experience

- 12–18 years of experience in pharmaceutical manufacturing engineering.
- Minimum 5 years in a senior engineering leadership position.
- Experience in managing a complete pharmaceutical manufacturing facility.
- Exposure to WHO-GMP, EU-GMP and US FDA-regulated facilities.
- Experience in greenfield and brownfield pharmaceutical projects will be an added advantage.
- Experience in handling formulation facilities, particularly sterile/injectable manufacturing, is desirable depending on the facility's dosage form.

6. Key Interfaces

The Engineering Head will work closely with:

- Plant Head / Site Head
- Production Department
- Quality Assurance (QA)
- Quality Control (QC)
- Validation Department
- EHS Department
- Supply Chain & Purchase
- External consultants and service providers

Pay: ₹330,000.00 - ₹2,000,000.00 per year

Benefits:

- Provident Fund

Work Location: In person

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