Site Engineering Head

Location:

Role Summary

Lead the complete Engineering & Maintenance function for an API (cytotoxic) manufacturing site. Ensure regulatory compliance, plant reliability, and execution of engineering projects while driving operational excellence, safety, and cost efficiency.

Key Responsibilities

• Oversee end-to-end engineering, utilities, and maintenance operations for API facilities.
  
• Ensure compliance with USFDA, EU GMP, MHRA, and other global regulatory standards.
  
• Lead USFDA and international regulatory audit preparedness for engineering.
  
• Drive preventive/predictive maintenance, equipment qualification, and documentation.
  
• Manage CAPEX projects, plant expansion, modernization, and containment upgrades.
  
• Oversee utilities including HVAC with BIBO, purified water, compressed air, ETP, and critical API/cytotoxic equipment.
  
• Ensure effective containment systems, OEL compliance, isolators, scrubbers, and safety controls.
  
• Implement automation, energy efficiency, and sustainability initiatives.
  
• Build and lead a high-performing engineering team with strong technical capabilities.
  

Qualifications

• B.E./B.Tech in Mechanical/Electrical/Chemical/Industrial Engineering (Master’s preferred).
  

• 15+ years

  of experience in API/pharma engineering, including exposure to regulated markets.
• Proven experience handling USFDA/EU GMP audits as Engineering Lead.
  

Key Competencies

• Regulatory compliance & audit readiness
  
• Containment & cytotoxic facility engineering
  
• Project management & CAPEX planning
  
• Leadership, team development, and problem-solving
  
• Focus on safety, reliability, and operational excellence