Lead - Equipment Maintenance - Mechanical

Role & responsibilities

Role Summary

This role is responsible for leading the operations and maintenance of manufacturing equipment within the TS block, covering solution preparation systems, filling lines, terminal sterilizers, visual inspection units, and packing machinery. The position requires strong mechanical expertise to manage equipment setup, upgrades, and process improvements, ensuring alignment with regulatory standards from global health authorities.

A key focus of the role is to enhance equipment reliability through proactive maintenance strategies, root cause analysis, and continuous improvement initiatives. The incumbent will also be accountable for building and nurturing a high-performance team culture by fostering collaboration, ownership, and accountability at all levels.

In addition to technical leadership, the role involves developing people capabilities through structured coaching, mentoring, and skill-building programs. The individual will play a pivotal role in shaping a culture of excellence, safety, and compliance, while driving operational efficiency and sustainable performance.

Key Responsibilities

Equipment Maintenance & Reliability Engineering

- Develop and implement preventive and predictive maintenance strategies to enhance equipment reliability and minimize downtime.
- Lead root cause analysis and troubleshooting of mechanical failures, ensuring timely resolution and documentation. - Drive spare parts planning, FMEA completion, and maintenance SOP adherence across all equipment. - Establish and maintain a network of qualified mechanical service vendors and ensure timely execution of maintenance contracts. - Monitor equipment performance trends and implement mechanical upgrades or modifications to improve efficiency and compliance.

- Vendor network development for Mechanical works.

Equipment Qualification

- Lead the mechanical design review and technical evaluation of new equipment, ensuring alignment with process requirements and regulatory expectations.
- Prepare and review User Requirement Specifications (URS), and coordinate with vendors for technical discussions and solution finalization. - Oversee and approve Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and qualification protocols (IQ, OQ, IOQ, PQ, PRQ, PV). - Review and validate engineering drawings including P&IDs, mechanical layouts, and utility schematics. - Coordinate with internal stakeholders and external agencies for equipment installation, commissioning, and validation.

Project Management

- Lead the planning, design, and execution of capital and improvement projects, including mechanical infrastructure upgrades and equipment expansions.
- Monitor project timelines, budgets, and resource allocations, ensuring alignment with business objectives. - Identify and implement opportunities for mechanical and operational improvements in safety, energy efficiency, and productivity. - Ensure successful execution of shutdown activities with a focus on mechanical readiness, safety, and minimal disruption.

- Ensuring Implementation of Global Reliability Program (GRP) and Capital projects per plan

- Planning and execution of shutdown activities on safely & timely manner

Documentation, Compliance & Audit Readiness

- Ensure all engineering activities comply with cGMP, GDP, GEP, and EHS standards.
- Maintain comprehensive documentation including mechanical specifications, risk assessments, and validation records. - Support internal and external audits, regulatory inspections, and ensure timely closure of deviations, incidents, and CAPAs. - Drive audit preparedness and ensure all mechanical systems are inspection-ready at all times.

Reporting & Analysis

- Track and analyze mechanical equipment performance, failure trends, and maintenance KPIs.
- Prepare monthly reports, annual budgets, and MIS dashboards for leadership review. - Ensure financial discipline by managing departmental expenses within approved limits.

People Leadership & Capability Development

- Lead, mentor, and develop a technically strong engineering team with a focus on mechanical competencies.
- Facilitate structured goal setting, performance reviews, and Individual Development Plans (IDPs). - Promote a culture of accountability, collaboration, and continuous learning. - Provide coaching and technical guidance to enhance team capabilities in mechanical troubleshooting, project execution, and compliance.

Cultural & Organizational Alignment

Statutory requirements:

• Expected to conduct themselves in line with relevant legislation pertaining to workplace health and safety, discrimination, harassment and bullying.

Environmental Health and Safety:

• Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.
• Ensure personnel safety.

Essential Requirements

Education:

- B.E. / B.Tech in Mechanical Engineering or a related discipline.

Experience:

- 15+ years of progressive experience in engineering maintenance and mechanical systems within the pharmaceutical or regulated manufacturing industry.

Core Competencies:

- Strong knowledge of injectable manufacturing equipment and cleanroom operations.
- Proficiency in interpreting and reviewing P&ID, mechanical, and utility drawings. - Expertise in mechanical systems design, troubleshooting, and reliability engineering. - Familiarity with cGMP, regulatory guidelines, and statutory compliance. - Skilled in project management, vendor coordination, and capital budgeting. - Demonstrated ability in people management, coaching, and team development. - Excellent communication, negotiation, and interpersonal skills. - Cultural awareness and ability to lead diverse teams. - Strong execution mindset with a focus on results and continuous improvement.