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.
