KEY STAKEHOLDERS: EXTERNAL
Govt Departments, Regulatory Agencies, Suppliers, Vendors
REPORTING STRUCTURE: Reports to Global Engineering & Project head & Site head , Direct reportees all plant engineering & maintenance team
ESSENTIAL QUALIFICATION: Bachelor’s degree in Engineering (Mechanical, Electrical, or related field)
- RELEVANT EXPERIENCE: > 20 years in a Pharmaceutical API Facility
- Qualification : B.Tech (Mechanical)
Experience: 20 Years +
KEY ROLES/RESPONSIBILITIES
Leadership & Strategy
Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence.
Develop and execute a comprehensive maintenance strategy, ensuring a proactive approach to maintenance, asset integrity, and equipment reliability.
Drive continuous improvement initiatives to optimize plant performance and reduce unplanned downtime.
Manage operating expenditure (OPEX) budgets for Engineering & Maintenance activities.
Maintenance & Reliability Management
Ensure all critical equipment and systems are maintained in optimal condition to meet production goals and regulatory requirements.
Oversee the implementation of preventive and predictive maintenance programs, improving plant uptime and reliability.
Develop and implement a comprehensive asset management strategy, including lifecycle management for critical equipment.
Regulatory Compliance & Safety
Ensure all maintenance activities are compliant with GMP, FDA, and other relevant pharmaceutical regulations.
Promote a culture of safety and adherence to the highest environmental, health, and safety (EHS) standards.
Lead the investigation and resolution of any maintenance-related incidents, ensuring timely and effective corrective actions.
Team Development & Talent Management
Mentor, train, and develop Engineering & Maintenance personnel, ensuring their skills and capabilities meet the evolving needs of the plant.
Foster a culture of collaboration, teamwork, and continuous learning within the team.
Lead recruitment efforts to fill skill gaps within the department and drive talent development initiatives.
Collaboration & Cross-Functional Coordination
Work closely with Production, Quality, and Supply Chain departments to ensure alignment between maintenance schedules and production plans.
Collaborate with the plant leadership team to identify opportunities for process optimization, cost reductions, and productivity improvements.
Technology & Innovation
Identify and implement new technologies that improve equipment performance, reduce maintenance costs, and enhance production efficiency.
Stay current with industry best practices, technology advancements, and emerging trends in pharmaceutical manufacturing and maintenance
KEY COMPETENCIES
Must have extensive experience in API pharmaceutical manufacturing, with a deep understanding of CGMP, FDA regulations, and other regulatory audit requirements. Expertise in ensuring compliance with these standards while optimizing maintenance strategies and driving operational improvements is essential. The role requires a strong track record in managing audits, addressing non-conformities, and maintaining a high standard of product quality and safety. Bachelor of Engineering (BE)
