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.
