Apply in 3 Minutes: Engineering Manager

Position Summary: The manager – Engineering will be responsible for overseeing and managing the entire engineering and maintenance functions for Life sciences (API) operations at the Tarapur site. The role demands a strategic leader with regulated market exposure, extensive experience in handling USFDA audits, and expertise in engineering operations, containment systems, and facility maintenance. The ideal candidate must have hands-on experience handling cytotoxic product equipment, isolators, HVAC systems with BIBO (Bag-In Bag-Out), wet scrubbers, OEL (Occupational Exposure Limit) studies, containment design, and maintenance to ensure compliance with stringent regulatory requirements. Key Responsibilities: Engineering & Maintenance Leadership: - Lead the overall engineering function for API operations, ensuring smooth plant operations and regulatory compliance. - Develop and implement engineering strategies to optimize production efficiency, minimize downtime, and ensure cost-effective maintenance. - Drive the preventive and predictive maintenance programs for all critical equipment and utilities. Regulatory Compliance & Audit Readiness: - Ensure the engineering function complies with USFDA, EU GMP, MHRA, and other global regulatory standards. - Play a key role in handling USFDA and other regulatory audits as the Engineering Head, ensuring all compliance requirements are met. - Maintain audit readiness by implementing best practices in equipment qualification, validation, and documentation. - Ensure that containment systems and OEL study protocols are in compliance with regulatory and safety standards. Project Management & Facility Upgradation: - Lead expansion, upgradation, and modernization projects for both formulation and API facilities, with a focus on cytotoxic manufacturing and containment technology. - Oversee capital expenditure (CAPEX) projects, ensuring timely completion within budget. - Implement energy efficiency and sustainability initiatives to optimize operational costs. - Supervise containment design, isolators, and wet scrubber systems to ensure compliance with occupational exposure guidelines. Utilities & Equipment Management: - Manage and maintain critical utilities such as HVAC with BIBO (Bag-In Bag-Out) systems, purified water systems, compressed air, and effluent treatment plants. - Ensure the availability and optimal performance of manufacturing equipment, clean rooms, reactors, packaging lines, and cytotoxic handling systems for both formulations and API production. - Implement automation and digitization in engineering processes for better efficiency, compliance, and data tracking. - Conduct OEL studies and monitor exposure control measures to ensure workplace safety and regulatory adherence. Safety, Environment & Compliance: - Ensure adherence to HSE (Health, Safety & Environment) policies and drive a culture of safety in all engineering operations. - Monitor environmental compliance, including effluent treatment, hazardous waste management, and containment system validations as per local and international guidelines. - Ensure all containment design and maintenance protocols adhere to industry best practices to minimize occupational exposure risks. Team Leadership & Development: - Build and lead a high-performing engineering team, ensuring continuous skill development and performance management. - Foster a culture of innovation, accountability, and operational excellence within the engineering function. - Train teams on cytotoxic product handling, isolator maintenance, and containment best practices to enhance technical expertise. Specialized Skills & Competencies: - Regulatory Knowledge: Strong understanding of USFDA, EU GMP, and regulatory compliance in engineering functions. - Containment Technology Expertise: Experience in handling cytotoxic product equipment, isolators, HVAC with BIBO, wet scrubbers, and OEL studies. - Project Management: Hands-on experience in leading expansion and upgradation projects, including containment system installations. - Leadership & Team Management: Proven ability to lead, mentor, and develop high-performing engineering teams. - Problem-Solving & Innovation: Ability to drive continuous improvement and adopt new technologies for enhanced efficiency. Key Performance Indicators (KPIs): - Audit Readiness & Compliance: Zero critical observations in regulatory audits. - Operational Efficiency: Reduction in downtime and improvement in overall equipment efficiency (OEE). - Project Execution: Timely completion of CAPEX projects within budget. - Energy & Cost Optimization: Implementation of cost-saving and energy-efficient initiatives. - Safety & Environmental Compliance: Adherence to HSE standards with zero safety incidents. - Containment System Effectiveness: Compliance with OEL limits and optimal performance of BIBO, isolators, and wet scrubbers.