Engineering Head

Job Description: Head of Maintenance (General Manager Level)

Position Title: Head of Maintenance

Company: Syngene International Limited

Location: Bengaluru, Karnataka, India

Department: Engineering and Maintenance

Reports To: Head of Engineering Projectsand Maintenance

Employment Type: Full-Time

Position Summary:

Syngene International Limited, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) and a subsidiary of Biocon, is seeking a strategic and hands-on Head of Maintenance to lead all maintenance operations across our integrated R&D and manufacturing facilities. This pivotal role will drive operational excellence, ensure seamless facility uptime, and align maintenance strategies with Syngene's innovation-driven mission in pharmaceuticals, biotechnology, and specialty chemicals. The incumbent will oversee a team of maintenance leaders, foster a culture of safety and compliance in a GMP/cGMP environment, and contribute to engineering projects to support business growth. With a focus on reliability, sustainability, and cost-efficiency, this position plays a critical role in minimizing downtime and enabling Syngene's world-class services for clients.

Key Responsibilities

• Strategic Leadership and Team Management: Lead, mentor, and develop a high-performing team of maintenance heads across business units, ensuring alignment with organizational goals. Foster cross-functional collaboration with R&D, manufacturing, quality, and operations teams to support CRDMO deliverables.

• Maintenance Strategy and Execution: Design, implement, and optimize comprehensive maintenance programs, including preventive, predictive, and corrective maintenance for equipment, utilities (HVAC, electrical, boilers, water systems), facilities, and instrumentation. Own the Computerized Maintenance Management System (CMMS) and drive metrics like MTTR (Mean Time to Repair), MTBF (Mean Time Between Failures), and schedule adherence.

• Compliance and Risk Management: Ensure 100% compliance with GMP/cGMP regulations, ISO standards, safety protocols, and environmental norms. Represent the department during regulatory audits (e.g., USFDA, EMA), internal inspections, and client audits, achieving zero observations through robust CAPA (Corrective and Preventive Actions) processes. Manage mechanical integrity programs in PSM (Process Safety

Management) environments. Thorough knowledge of safety systems and statutory compliances.

• Budget and Resource Optimization: Develop and manage annual maintenance budgets, including CAPEX for upgrades and OPEX for spares/inventory. Ensure time to time upgrade of equipment and facility to ensure optimal cost and minimize the repairs cost while maintaining 24/7 operational reliability.

• Engineering Projects Oversight: Leverage engineering expertise to support Central Projects team in facility expansion or modifications projects, shutdown planning, and technology integrations (e.g., 3D printing for spares, digital twins for predictive maintenance). Collaborate on asset investment programs to enhance scalability for biologics, small molecules, and formulation services.

• Continuous Improvement and Innovation: Champion Lean, Six Sigma, DMAIC methodologies, and digitalization initiatives (e.g., IIoT for asset monitoring) to drive efficiency, reduce energy consumption, and promote sustainability. Analyze utility data (e.g., electricity, water) and implement cost-saving measures.

• Operational Excellence: Coordinate cross-site shutdowns, ensure audit-readiness of the facilities at all times, and prepare MIS reports on KPIs for senior leadership. Handle unscheduled breakdowns to maintain zero-impact on production timelines. Identify and drive multiple initiatives to enhance productivity in EnM and ensure reliability of assets.

• People Development: Drive performance management, and succession planning for the maintenance function. Promote a safety-first culture with regular risk assessments and employee engagement initiatives.

Qualifications and Experience

• Educational Background: Bachelor's degree in Mechanical, Electrical, Chemical, or Instrumentation Engineering from a recognized institution. Advanced certifications (e.g., PMP, CMRP, Six Sigma Black Belt) preferred.

• Professional Experience: Minimum 15+ years in maintenance/engineering roles within pharmaceutical, biotechnology, or CRDMO organizations, with at least 8-10 years in senior leadership positions overseeing multi-disciplinary teams. Proven track record in biologics manufacturing, GMP facilities, and handling complex projects (e.g., facility expansions valued up to INR 50-100 crores). Experience in a high-volume CRDMO environment like Syngene or similar (e.g., Biocon, Piramal, Roche) is highly desirable.

• Technical Expertise: In-depth knowledge of processes and process equipment , regulatory guidelines (USFDA, EMA), CMMS tools, and utility systems (HVAC, cleanrooms, WFI systems). Understanding of PLC/SCADA systems and total Asset Life

cycle management. Familiarity with energy management, calibration protocols, and predictive maintenance technologies.

• Leadership and Soft Skills: Demonstrated ability to lead diverse teams in a matrixed structure with multi-disciplinary skills, strong change management, stakeholder communication, and problem-solving skills. Proficiency in budgeting, vendor management, and cross-functional project execution to develop long term strategies for asset reliability.

Key Competencies

Competency Description

Strategic Thinking: Ability to align maintenance strategies with business objectives and anticipate future needs in a dynamic CRDMO landscape.

Technical Acumen: Expertise in engineering principles, reliability engineering, and innovation in maintenance practices.

Compliance Focus: Unwavering commitment to quality, safety, and regulatory standards in a high-stakes pharma environment.

Leadership & Influence: Proven people management skills to motivate teams, resolve conflicts, and drive performance.

Analytical & Innovative: Skilled in data-driven decision-making, root cause analysis, and implementing process improvements.