AGMDGM Engineering Head (Injectable)

Job Summary

We are looking for an experienced AGM / DGM – Site Engineering Head to lead the Engineering function at a USFDA-approved Injectable manufacturing facility. The incumbent will be responsible for ensuring high equipment reliability uninterrupted utility availability regulatory compliance engineering projects and continuous improvement initiatives while leading a large cross-functional engineering team.

Key Responsibilities

• Lead the complete Site Engineering function including Maintenance Utilities Projects Automation and Engineering Compliance.
• Ensure maximum uptime and reliability of manufacturing packaging and utility equipment.
• Manage preventive predictive and breakdown maintenance activities to minimize downtime.
• Oversee engineering operations for Injectable manufacturing including aseptic processing areas.
• Ensure compliance with USFDA MHRA EU GMP WHO GMP and other global regulatory requirements.
• Lead engineering qualification activities including IQ OQ PQ FAT SAT and equipment commissioning.
• Manage engineering projects from concept to commissioning within approved timelines and budgets.
• Ensure uninterrupted operation of critical utilities including:
  • HVAC Systems
  • Water System (PW/WFI)
  • Pure Steam
  • Compressed Air
  • Chillers
  • Boilers
  • Cooling Towers
  • Nitrogen Systems
  • Electrical Distribution
  • DG Sets
• Drive energy conservation and cost optimization initiatives across the site.
• Ensure engineering documentation SOPs calibration validation and maintenance records remain audit-ready.
• Support regulatory inspections and customer audits by addressing engineering-related observations.
• Lead root cause investigations CAPA implementation risk assessments and continuous improvement initiatives.
• Develop engineering budgets monitor expenditures and optimize maintenance costs.
• Build and mentor a high-performing engineering team while driving safety and operational excellence.