Job Title: Head Engineering & Maintenance
Location:
Number of positions
Purpose of the Role
strategic engineering initiatives
Accountability Tracks
1. Strategic Engineering
- Develop and execute engineering strategies aligned with the organization’s business growth, expansion, and regulatory goals.
- Plan and implement capital investment projects (equipment upgrades, new facility setups, energy-saving initiatives).
- Ensure engineering systems and utilities comply with USFDA, EMA, and other global cGMP standards.
- Act as a subject matter expert during regulatory audits, inspections, and customer visits on engineering-related areas.
- Implement sustainability initiatives (energy efficiency, water management, effluent handling) to optimize costs and environmental impact.
- Drive innovation in engineering practices (automation, digital monitoring, advanced CMMS).
2. Maintenance Operations
- Ensure continuous availability and reliability of all plant equipment, utilities, and infrastructure.
- Lead preventive, predictive, and breakdown maintenance across production equipment, utilities (boilers, chillers, compressors, HVAC, WFI, RO/DM systems), and effluent treatment plants.
- Monitor and improve KPIs for equipment uptime, MTBF (Mean Time Between Failures), and MTTR (Mean Time to Repair).
- Ensure timely equipment calibration, qualification, and documentation in line with GMP.
- Drive quick and effective troubleshooting of equipment failures, minimizing impact on production schedules.
- Maintain engineering documentation (logbooks, SOPs, maintenance records) to ensure audit readiness.
- Enforce EHS compliance and promote safe practices across all engineering activities.
- Train, mentor, and develop engineering and maintenance teams to build strong technical capability.
Key Technical Competencies
- Strong knowledge of API/Pharma plant utilities and equipment.
- Expertise in preventive & predictive maintenance systems, preferably through CMMS.
- Familiarity with equipment qualification, calibration, and validation.
- Deep understanding of cGMP requirements and regulatory audit expectations.
- Knowledge of automation, instrumentation, and energy management practices.
Key Behavioral Competencies
Strategic Thinking:
Ability to align engineering roadmap with business and regulatory priorities.Problem-Solving:
Structured approach to root cause analysis and technical troubleshooting.Collaboration:
Strong cross-functional coordination with QA, Production, RA, and EHS.Leadership:
Ability to inspire, coach, and retain a high-performing engineering team.Accountability:
Ownership for plant reliability, compliance, and cost optimization.Agility:
Ability to respond rapidly to equipment issues or audit demands.
Educational Qualification & Experience
Education:
B.E./B.Tech in Mechanical / Electrical / Instrumentation / Chemical Engineering.Experience:
12–18 years in Engineering & Maintenance in a mid-sized API/Pharma plant, with minimum 5 years in a senior managerial role.
Internal Stakeholders
- Production & Manufacturing
- Quality Assurance & Quality Control
- Regulatory Affairs
- EHS
- Supply Chain & Procurement
External Stakeholders
- Equipment & Utility Vendors
- Calibration & Service Providers
- Contractors & Consultants
- Statutory Authorities (Pollution Control Board, Boiler Inspectorate, etc.)
- Regulatory Agencies (during inspections)
Core Performance Dimensions
Dimension
Success Indicators
Strategic Engineering
Timely execution of capital projects; compliance of facilities/utilities with global GMP
Equipment Uptime
Reduction in downtime, improved MTBF, adherence to maintenance KPIs
Preventive Maintenance
95% adherence to preventive/predictive maintenance schedule
Regulatory Compliance
Zero major/critical audit observations in engineering & maintenance areas
Energy & Cost Optimization
% savings in energy, water, and utility costs annually
EHS & Safety
Zero safety incidents/accidents in engineering domain
Team Capability
Skill development, retention, and performance of engineering team