Engineering Head

The Head of Engineering owns end-to-end engineering performance at Knovea's Indore injectable manufacturing facility from equipment reliability (Isolators, Powder and liquid fill machines, Lyophilisers, others..) and critical utilities (boilers, HVAC, WFI/pure steam, compressors, DG sets and others..) to GMP compliance, regulatory audit readiness, and CAPEX/OPEX budget management.

Key Responsibilities

Maintenance & Equipment Reliability

• Ensure effective planning, scheduling, and execution of preventive maintenance for all plant equipment.
• Ensure timely and effective breakdown maintenance of all plant equipment.
• Maintain minimum required inventory of spares for all plant equipment.
• Plan, schedule, and allocate work across the team, ensuring timely completion and effective utilization of manpower.
• Investigate all equipment/process failures and ensure corrective and preventive actions (CAPA) related to Engineering.
• Maintain a visible, hands-on presence on the shop floor personally involved in critical maintenance activities, breakdowns, and escalations rather than managing remotely.

Utilities & Critical Systems

• Own end-to-end operation, maintenance, and reliability of critical utilities including boilers, compressors, DG sets, HVAC/AHUs, water systems (WFI/pure steam), and other critical plant infrastructure.
• Ensure statutory compliance and safe operation of all pressure equipment and utility systems (boiler certification, pressure vessel inspections, etc.).
• Drive uptime and efficiency improvements across utility systems through preventive monitoring and timely intervention.

Compliance & Safety

• Ensure GMP and safety systems are strictly followed during all work execution, with zero GMP violations.
• Drive safety awareness across the team and ensure attendance at HSE training.
• Train and develop subordinates on current regulatory requirements and good engineering practices.

Regulatory & Audit Management

• Lead engineering readiness and represent Engineering during regulatory inspections and audits (USFDA, EU-GMP, WHO-GMP, and other applicable bodies).
• Ensure timely closure of audit observations and CAPAs related to engineering and utility systems.
• Maintain qualification, calibration, and validation documentation for critical equipment and utilities in an audit-ready state at all times.

Budget & Cost Ownership

• Own and manage the annual Engineering CAPEX and OPEX budget, including planning, approvals, and variance tracking.
• Drive reduction in revenue budget spend, material loss, and energy consumption (power, fuel, water, consumables, etc.).
• Identify and implement automation, mechanization, and digitization opportunities to improve quality compliance and productivity.

Digital Systems & Documentation

• Drive adoption and effective use of CMMS/digital maintenance systems (e.g., SAP PM or equivalent) for planning, tracking, and reporting maintenance activities.
• Oversee material management, bill tracking and reconciliation, and documentation.

Projects & Vendor Management

• Lead selection and technical evaluation of engineering equipment, and validate vendor recommendations.
• Coordinate with consultants and vendors for smooth design, execution, and closure of projects.
• Track project plans, CAPEX, and schedules; escalate issues to the Plant Head as needed.
• Coordinate with government authorities for statutory and regulatory approvals.

Team & Stakeholder Management

• Build strong working relationships with cross-functional and interdepartmental teams (Production, Quality, and others) — demonstrating genuine teamwork spirit beyond the Engineering function.
• Lead clear, effective communication and discussions with domestic and international stakeholders, including vendors, consultants, and regulatory bodies.
• Manage internal and external communication related to engineering operations.
• Forecast workload and manage work progress within the function; prioritize tasks, delegate work, and ensure timely delivery.

Qualifications & Experience

• B.E./B.Tech in Mechanical/Electrical/Instrumentation Engineering (or equivalent); M.E./M.Tech preferred but not mandatory.
• Injectable manufacturing experience is mandatory — prior experience in a sterile/injectable pharmaceutical manufacturing facility including Isolators, Dry Powder Fill, meant for regulated markets is a must-have, not just preferred.
• Prior experience in a regulated (pharma/GMP) manufacturing environment, specifically injectables, is required.
• Demonstrated experience managing CAPEX/OPEX budgets, vendor relationships, and statutory/regulatory approvals in a sterile manufacturing setup.
• Proven experience handling regulatory audits (USFDA/EU-GMP/WHO-GMP) from an engineering standpoint.

Key Skills

• Preventive & breakdown maintenance planning
• GMP/HSE compliance
• CAPEX/OPEX budget ownership and cost control
• Utilities and critical systems management (boilers, HVAC, WFI/pure steam, compressors, DG sets)
• CMMS/digital maintenance systems (SAP PM or equivalent)
• Regulatory audit readiness and management
• Vendor and consultant management
• Hands-on, shop-floor leadership style
• Cross-functional teamwork and stakeholder management
• Sterile/aseptic area engineering (cleanroom qualification, environmental monitoring)
• Excellent communication skills, with the ability to lead discussions and negotiations with both domestic and international stakeholders