will lead and oversee all engineering, project execution, production-support activities, and plant maintenance operations across the pharmaceutical manufacturing facility. The role ensures that all projects, utilities, and equipment comply with
GMP, cGMP, USFDA, MHRA
, and other regulatory standards. The candidate will manage cross-functional teams, drive continuous improvement, and ensure smooth and uninterrupted pharma production operations.
Key Responsibilities1. Project Management
Lead end-to-end planning, execution, and commissioning of all new projects, expansions, and facility upgrades.
Prepare project feasibility, budgeting, timelines, and resource planning.
Coordinate with contractors, consultants, vendors, and internal teams.
Ensure project delivery within timeline, cost, and quality parameters.
2. Engineering & Maintenance
Oversee preventive, predictive, and breakdown maintenance for all pharma production equipment.
Manage utilities like
HVAC, AHUs, Water Systems (WFI, PW, RO), Compressed Air, Boilers, DG Sets
, etc.
Ensure 24/7 availability of equipment and uninterrupted production operations.
Implement energy-saving initiatives and cost optimization in utility operations.
3. Production Support
Provide engineering support for manufacturing, packaging, QA/QC, and warehouse operations.
Troubleshoot equipment issues to minimize downtime.
Ensure equipment cleaning, calibration, and qualification as per GMP guidelines.
4. Compliance & Documentation
Ensure compliance with
GMP, cGMP, USFDA, MHRA
, and other regulatory requirements.
Prepare and maintain engineering SOPs, protocols, validation documents (IQ/OQ/PQ), and audit records.
Lead and support regulatory inspections, internal audits, and customer audits.
5. Team Leadership
Lead and mentor engineering, maintenance, and project teams.
Conduct training on safety, equipment handling, and maintenance systems.
Monitor contractor performance and ensure compliance with plant safety rules.
6. Safety & Quality
Implement HSE (Health, Safety & Environment) procedures across the plant.
Ensure all equipment, pipelines, and utilities operate safely and smoothly.
Conduct risk assessments and implement corrective/preventive actions.
Required Skills & Competencies
Strong knowledge of
pharma plant engineering
, production machinery, and utilities.
Expertise in
project management, plant layout, installation, and commissioning
, etc.
Excellent leadership, communication, and vendor management skills.
Ability to work in high-pressure environments and support 24/7 operations when needed.
Educational Qualification
B.E./B.Tech in Mechanical, Electrical, Chemical, or Industrial Engineering