Experience required: 0 Years

A. Engineering & Maintenance
Lead preventive, predictive, and breakdown maintenance activities for manufacturing equipment, utilities, and plant infrastructure.
Ensure maximum equipment availability, reliability, and operational efficiency.
Develop and implement maintenance strategies, annual maintenance plans, and equipment lifecycle management programs.
Monitor equipment downtime, MTBF, MTTR, maintenance costs, and reliability KPIs.
Ensure proper maintenance documentation, work orders, equipment history, and maintenance records.
B. Utility & Facility Management
Manage critical pharmaceutical utilities, including HVAC, AHUs, purified water (PW), water for injection (WFI), pure steam, compressed air, nitrogen, chillers, boilers, cooling towers, and vacuum systems, as applicable.
Ensure reliable operation of cleanrooms, environmental control systems, and critical utility systems.
Maintain facility conditions in compliance with applicable GMP requirements.
Coordinate utility monitoring, preventive maintenance, and periodic performance assessments.
C. Projects & Capital Expenditure
Lead engineering projects involving new equipment installation, plant expansion, modernization, and capacity enhancement.
Prepare technical specifications, URS, engineering budgets, and capital expenditure proposals.
Coordinate design reviews, vendor selection, procurement, installation, commissioning, and qualification.
Ensure project execution within approved budgets, timelines, quality standards, and safety requirements.
Manage contractors, consultants, OEMs, and engineering service providers.
D. GMP, Compliance & Validation
Ensure engineering systems comply with cGMP, applicable regulatory requirements, and internal quality standards.
Support equipment qualification, including DQ, IQ, OQ, and PQ, as applicable.
Ensure calibration, preventive maintenance, change control, deviation investigations, CAPA, and risk assessments are completed on time.
Participate in internal audits, customer audits, and regulatory inspections.
Maintain engineering SOPs, logbooks, drawings, technical documentation, and equipment qualification records.
Collaborate with Quality Assurance, Quality Control, Production, Validation, and EHS teams to maintain a state of control.
E. Energy, Cost & Resource Optimization
Develop and implement energy conservation and utility optimization initiatives.
Control engineering expenditure, spare-parts inventory, and maintenance budgets.
Identify opportunities to reduce utility consumption, equipment downtime, and operating costs.
Evaluate engineering performance and implement continuous improvement initiatives.
F. Team Leadership & Development
Lead engineering, maintenance, utilities, and project teams.
Define departmental objectives, KPIs, manpower plans, and training requirements.
Develop technical competencies and succession plans for engineering personnel.
Ensure adherence to safety procedures, permit-to-work systems, and contractor safety requirements.
Promote a culture of accountability, operational excellence, and continuous improvement.