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 .