Engineering ManagerConfidential • Tarapur, India
Engineering Manager
Confidential • Tarapur, India
12 days ago
Job descriptionEnsure 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. 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. 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. 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. 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. 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 . 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 .
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 :
Project Management & Facility Upgradation :
Utilities & Equipment Management :
Safety, Environment & Compliance :
Team Leadership & Development :
Specialized Skills & Competencies :
Key Performance Indicators (KPIs) :
Skills Required
Facility Maintenance, environmental compliance, isolators , Hazardous Waste Management
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Engineering Manager • Tarapur, India
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