18 - 28 years

20 - 30 Lacs

Posted:1 week ago| Platform: Naukri logo

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Full Time

Job Description

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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

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