Role & responsibilities
Job Responsibilities /Deliverables
- Project Planning & Execution
- Lead execution of greenfield, brownfield, capacity expansion, and facility modification projects.
- Prepare project schedules, monitor progress, and ensure timely completion within approved budgets.
- Coordinate with internal stakeholders, consultants, vendors, and contractors throughout the project lifecycle.
- Monitor project risks and drive timely closure of project deliverables.
Mechanical & Process Equipment Projects
- Lead installation, commissioning, and handover of OSD manufacturing equipment such as: Dispensing Systems, Granulation Equipment, Fluid Bed Dryers (FBD), Rapid Mixer Granulators (RMG), Compression Machines, Coating Machines, Capsule Filling Machines, Packing Equipment
- Review equipment layouts and utility requirements.
- Coordinate FAT, SAT, installation, and qualification activities with OEMs and validation teams.
- Ensure equipment installation complies with approved drawings and GMP requirements.
HVAC & Cleanroom Projects
- Coordinate design review, installation, testing, and commissioning of HVAC systems for Grade C & Grade D classified areas.
- Review HVAC layouts, duct routing, airflow concepts, pressure cascades, and cleanroom requirements.
- Support AHU, Dehumidifier, Dust Collector, Chiller, and Ventilation System projects.
- Coordinate air balancing, HEPA integrity testing, and cleanroom qualification activities.
- Ensure HVAC systems meet approved temperature, RH, pressure differential, and cleanroom requirements.
Utility & Infrastructure Projects
- Execute utility-related projects including: Chiller Systems, Cooling Towers, Air Compressors, Vacuum Systems, Purified Water Systems, DG Sets.
Electrical Infrastructure
- Coordinate utility integration with manufacturing and facility systems.
- Support utility capacity assessment and future expansion planning.
Qualification & Validation Support
- Coordinate IQ, OQ, and PQ activities for equipment, utilities, and HVAC systems.
- Review qualification protocols and reports in coordination with QA and validation teams.
- Ensure project documentation is available for regulatory and GMP compliance requirements.
- Support execution of validation master plans related to projects.
GMP compliance requirements.
- Support execution of validation master plans related to projects.
- Vendor & Contractor Management
- Participate in technical evaluation of vendors and contractors.
- Review vendor documents, GA drawings, utility requirements, and technical submissions.
- Monitor site execution activities and ensure compliance with approved specifications.
- Track contractor performance, quality, safety, and project milestones.
CAPEX & Project Cost Management
- Assist in preparation of project budgets and CAPEX proposals.
- Monitor project costs against approved budgets.
- Support procurement activities through technical recommendations and bid evaluations.
- Ensure optimum utilization of project resources and budgets.
Documentation & Compliance
- Review URS, layout drawings, P&IDs, equipment specifications, and engineering documents.
- Ensure proper project documentation, as-built drawings, and handover dossiers.
- Support change controls, deviations, and project-related documentation activities.
Safety & EHS
- Ensure compliance with GMP, EHS, and engineering safety requirements during project execution.
- Monitor contractor safety practices and permit systems.
- Participate in risk assessments and project safety reviews.
- Ensure compliance with LOTO, work-at-height, hot work, and confined space procedures wherever applicable.
Additional Skills & Competencies
- OSD Manufacturing Equipment Projects
- HVAC Systems (Grade C & D)
- Utility Systems Integration
- FAT / SAT / IQ / OQ Coordination
- AutoCAD & Layout Review
- Project Planning & Scheduling
- Vendor Management
- CAPEX Management
- GMP, WHO, USFDA & Schedule M Awareness
- MS Project
Audit Support & Continuous Improvement
- Represent HVAC engineering during regulatory and customer audits.
- Ensure HVAC & BMS systems remain continuously audit-ready with updated documentation.
- Lead continuous improvement initiatives for HVAC performance, energy efficiency, and compliance.
Utilities & Energy Management
- Oversee operation and maintenance of utilities (HVAC, boilers, chillers, compressors, DG sets, ETP, STP) as needed
- Implement energy conservation and cost-reduction initiatives
- Conduct risk assessments and ensure compliance with safety regulations
- Investigate incidents and implement preventive measures.
- Ensure HVAC installation and modifications meet EHS standards (LOTO, electrical safety, confined space).
- Conduct risk assessments for HVAC/BMS modifications and commissioning activities.
Qualifications Education
- B.E./B.Tech in Mechanical Engineering
- Deep understanding of pharma cleanroom design, OSD equipments projects installations & regulatory compliance.
Preferred candidate profile
Candidate should have hands on experience in Briwn filed, green filed project in Pharma industries.