Engineering Head

Position Overview:

The Head of Mechanical Engineering will lead all mechanical engineering, maintenance, and project activities at the API manufacturing site. This includes oversight of plant utilities, process equipment, HVAC systems, water systems, and critical mechanical infrastructure. The role ensures high equipment reliability, compliance with cGMP and regulatory requirements, and continuous improvement in mechanical performance, energy efficiency, and safety.

Key Responsibilities

1. Mechanical Engineering Leadership

• Lead and manage the mechanical engineering team covering design, maintenance, and reliability functions.
  
• Develop and implement mechanical engineering standards, SOPs, and best practices aligned with pharma and regulatory norms (USFDA, EMA, WHO, etc.).
  
• Ensure mechanical integrity of all plant systems including reactors, heat exchangers, pressure vessels, centrifuges, dryers, chillers, boilers, air compressors, and utility systems.
  

2. Maintenance & Reliability

• Oversee preventive, predictive, and corrective maintenance programs for process and utility equipment.
  
• Implement reliability-centered maintenance (RCM) and root cause analysis (RCA) processes to minimize downtime.
  
• Ensure calibration, validation, and mechanical documentation are maintained per GMP and audit requirements.
  
• Drive uptime improvements and reduction in mechanical breakdowns across all areas.
  

3. Project Management

• Lead mechanical design and execution of capital projects, expansions, and equipment upgrades.
  
• Review engineering drawings, P&IDs, layouts, and mechanical specifications.
  
• Coordinate with vendors, EPC contractors, and internal project teams for timely completion within budget.
  
• Ensure adherence to safety, quality, and environmental standards in all project phases.
  

4. Utilities & Critical Systems

• Ensure reliable and compliant operation of utility systems steam, compressed air, HVAC, chilled/brine water, WFI, purified water, and effluent treatment systems.
  
• Monitor and optimize utility consumption for energy efficiency and cost control.
  
• Ensure validation and qualification of critical mechanical systems in coordination with QA/Validation teams.
  

5. Compliance, Documentation & Audits

• Ensure mechanical systems comply with cGMP, GEP (Good Engineering Practice), and local statutory requirements.
  
• Support regulatory and customer audits by providing technical documentation and evidence of compliance.
  
• Maintain engineering documentation URS, DQ, IQ, OQ, PQ, calibration records, and change control records.
  

6. People & Performance Management

• Lead a team of engineers, supervisors, and technicians with a focus on safety, ownership, and professional growth.
  
• Identify training needs and build technical competency within the engineering department.
  
• Drive a culture of continuous improvement, accountability, and innovation.

Qualifications

Education:

• B.E./B.Tech or M.E./M.Tech in Mechanical Engineering (preferably from a recognized institution).
  

Experience:

• 1525 years of experience in Mechanical / Plant Engineering within the

  API / Bulk Drug / Chemical / Pharmaceutical

  industry.
• Minimum 5 years in a senior leadership or head role managing maintenance, projects, and utilities.
  

Technical Expertise:

• Strong knowledge of mechanical equipment used in API manufacturing plants.
  
• Experience with pressure vessels, rotating machinery, piping systems, HVAC, and water systems.
  
• Hands-on experience with GMP documentation, validation, and audit readiness.
  
• Familiar with energy management, equipment reliability, and plant automation systems.