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Head of Engineering and Maintenance

Head of Engineering and Maintenance

Aarti Pharmalabs Ltd. (APL)Tārāpur, Republic Of India, IN
8 hours ago
Job description

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 .
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    Head Of Engineering • Tārāpur, Republic Of India, IN

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