Engineering Manager

Position Summary:

entire engineering and maintenance functions

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

  .