Site Engineering Head (Sterile/Injectables)

Job Summary

This role is for a Manufacturing Maintenance and Reliability Manager, responsible for ensuring the optimal functionality, calibration compliance, and reliability of manufacturing equipment across operations. The position drives zero downtime initiatives, leads preventive and breakdown maintenance programs, and manages the life cycle of critical assets through LDM, TPM, and continuous improvement strategies.

Key responsibilities include preparing CAPEX proposals, managing OPEX budgets, and executing projects within defined timelines and compliance frameworks. The role ensures adherence to GMP, safety standards, and validated process parameters, while promoting safety awareness and environmental compliance. It also involves managing QMS elements, audit readiness, and documentation practices.

' Roles & Responsibilities

• Maintain manufacturing equipment to ensure correct functionality, calibration compliance, and operation within validated process parameters.
• Develop and guide the team toward achieving zero downtime, higher equipment reliability, and maximum availability through proactive maintenance strategies.
• Lead continuous improvement initiatives such as LDM, TPM, debottlenecking, and resource optimization, while leveraging cross-site learnings for enhanced productivity and cost efficiency.
• Prepare CAPEX proposals, conduct feasibility studies, secure approvals, and ensure timely execution of projects in compliance with regulatory and business requirements.
• Manage OPEX budgeting, tracking, and monitoring, along with developing and reviewing KPIs to drive operational efficiency and cost control.
• Conduct breakdown analysis, improve preventive maintenance, and collaborate with cross-functional teams to resolve discrepancies and implement corrective actions.
• Ensure compliance with GMP, safety standards, and SOPs, maintain audit readiness, and manage QMS elements including documentation, CAPA closure, and training.
• Build a high-performing team by setting goals, conducting performance reviews, coaching employees, recognizing contributions, and driving capability development for seamless process engineering transitions.

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Educational Qualification

Graduation in Instrumentation Mechanical, Electrical, Engineering or related field is mandatory.
Post Graduation in Engineering / MBA is preferred.

Minimum Work Experience

15+ years of experience.

Skills & Attributes Functional Skills

• Asset Management
• Commissioning Qualification Validation (CQV)
• Total Cost of Ownership
• Equipment Maintenance
• Process Engineering
• Project Management
• Site Inspection
• Sustainability Initiatives

Resident Skills

• Audit Management
• Current Good Manufacturing Practices (cGMPs)
• Lean Methodologies
• Risk Management
• Total Productive Maintenance

Behavioural Skills

• Accountability and ownership - takes full responsibility for equipment performance, team outcomes, and compliance standards.
• Strategic thinking - anticipates operational challenges and drives long-term improvements through data-driven decisions and cross-functional collaboration.
• People development focus - invests in coaching, recognition, and capability building to foster a motivated and skilled workforce.

Critical Exposures

• 8+ years in Sterile engineering or plant maintenance roles, with 5+ years as team lead managing Mechanical / Electrical / HVAC / Instrumentation / Operations / Engineering Projects in pharma manufacturing is desired.
• Experience in cGMP, EHS, regulatory compliance and audit readiness in pharmaceutical manufacturing is desired.
• Experience with Computerized Maintenance Management System (CMMS), energy efficiency measures and sustainability initiatives for asset management is desired.
• Exposure in budget preparation and monitoring for CapEx and OpEx aligned with engineering objectives is preferred.
• Exposure to SCADA, BMS (Building Management Systems), and IoT-based predictive maintenance tools is preferred.

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