AM to Senior Manager Engineering

Palghar - India

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

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.