Head of Engineering

2 days ago

Bavla Gujarat, India RK HR Management Private Limited Full time

1. Project & Engineering Management

  • Lead all engineering activities from design to commissioning, ensuring adherence to project timelines and budgets.
  • Manage installation, qualification, and validation of HVAC, water systems (RO, WFI, PW), BMS, SCADA, boilers, chillers, air compressors, solar panels, and cleanroom facilities.
  • Review and approve engineering documentation: URS, design drawings (PFDs, P&IDs), specifications, and qualification protocols (DQ, IQ, OQ, PQ).
  • Coordinate with QA, validation, and construction teams to ensure compliance-by-design and readiness for EU-GMP inspection.
  • Liaise with vendors, consultants, and contractors to secure efficient and compliant project execution.
  • Ensure all engineering documentation meets GMP and corporate validation standards.

2. Maintenance, Reliability & Calibration

  • Implement preventive and predictive maintenance programs for all utilities, equipment, and systems.
  • Lead troubleshooting, root cause analysis (RCA), and corrective action implementation for technical deviations.
  • Optimize Overall Equipment Effectiveness (OEE) and energy efficiency of critical assets.
  • Supervise calibration and maintenance of all critical instruments and equipment to maintain GMP compliance.
  • Maintain an optimized inventory of spares and technical consumables to ensure business continuity.

3. Energy, Safety & Environmental Compliance

  • Drive energy optimization and sustainability initiatives, including solar power integration and water recycling.
  • Ensure compliance with GMP, EU-GMP, EHS, and local statutory regulations.
  • Oversee implementation of safety programs, risk assessments, and emergency preparedness.
  • Manage engineering documentation for regulatory audits and inspections.
  • Collaborate with QA to ensure utilities and facilities consistently meet validated conditions.

4. People Leadership & Capability Development

  • Build, lead, and mentor the
    engineering, maintenance, and utilities teams
    .
  • Conduct regular training on maintenance practices, safety, GMP compliance, and technical systems.
  • Promote a culture of ownership, teamwork, and technical excellence.
  • Develop succession plans and encourage continuous professional development.

5. Digitalization, Operational Excellence & Continuous Improvement

  • Deploy and manage Building Management Systems (BMS), SCADA, and Computerized Maintenance Management Systems (CMMS) for real-time monitoring and traceability.
  • Use data analytics and KPIs to monitor energy usage, maintenance performance, and downtime trends.
  • Lead continuous improvement and lean initiatives to enhance reliability, cost efficiency, and sustainability.
  • Support corporate digital transformation and integration with enterprise systems (ERP/SAP).

Qualifications & Experience

  • Bachelor's or Master's degree in Mechanical, Electrical, Instrumentation, or Automation Engineering (B.E./M.E., B.Tech/M.Tech).
  • 15+ years of experience in pharmaceutical or other GMP-regulated industries, with at least 5 years in a senior engineering leadership position.
  • Strong expertise in mechanical, electrical, HVAC design, BMS, SCADA, water systems, energy management, and cleanroom technologies.
  • Proven track record in Greenfield or expansion projects, equipment qualification, and project commissioning.
  • Deep knowledge of EU-GMP, EHS, and validation standards.
  • Familiarity with EMA or USFDA export market requirements.
  • Strong leadership, planning, and problem-solving skills.
  • Proficiency in English; knowledge of Hindi or Gujarati is an advantage.
  • Proficiency in MS Office, AutoCAD, and SAP/ERP systems preferred.

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