Key Responsibilities
Project Execution
- Execute assigned projects within approved budget, schedule, and quality standards.
- Coordinate with consultants, contractors, equipment suppliers, and internal stakeholders.
- Monitor project progress and prepare daily, weekly, and monthly reports.
- Review engineering drawings, specifications, BOQs, and technical documents.
- Track project milestones and identify risks affecting schedule or cost.
Engineering & Design
- Review layouts, P&IDs;, utility flow diagrams, equipment GA drawings, and construction drawings.
- Coordinate design changes through formal change control.
- Ensure compliance with GMP, engineering standards, and regulatory requirements.
- Support optimization of plant layouts and utility distribution.
Equipment & Utilities
Coordinate installation and commissioning of:
- Vial Filling Lines
- Isolators
- Lyophilizers
- Autoclaves
- Vial Washing Machines
- Depyrogenation Tunnels
- CIP/SIP Systems
- Process Vessels
- WFI Systems
- Pure Steam Generators
- Clean Utilities
- HVAC Systems
- Chillers
- Boilers
- Compressed Air Systems
- Electrical Systems
- Building Management System (BMS)
Knowledge of sterile injectable process equipment and facility integration is highly desirable.
Procurement Support
- Prepare technical specifications and tender documents.
- Perform techno-commercial evaluations.
- Participate in vendor meetings and technical clarifications.
- Review vendor drawings and documents.
- Support FAT and SAT activities.
Construction Management
- Supervise site execution activities.
- Monitor contractor productivity and quality.
- Ensure compliance with approved drawings and specifications.
- Verify measurement sheets and contractor bills.
- Conduct site inspections and punch point reviews.
Commissioning & Qualification
- Support DQ, IQ, OQ, and PQ activities.
- Coordinate commissioning of utilities and process equipment.
- Participate in FAT and SAT.
- Ensure completion of project documentation before handover.
Documentation
- Prepare project reports and presentations.
- Maintain project schedules using MS Project or Primavera.
- Review SOPs, engineering documents, and qualification protocols.
- Maintain document control for engineering deliverables.
Required Skills
- Pharmaceutical engineering and capital project execution
- Sterile injectable facility design
- HVAC for cleanrooms
- WFI and Pure Steam systems
- Process piping
- Utility engineering
- Equipment installation and commissioning
- Project planning and scheduling
- Cost estimation and budget control
- Vendor management
- Tender evaluation
- Construction supervision
- FAT, SAT, DQ, IQ, OQ, and PQ
- GMP documentation
- AutoCAD
- MS Project / Primavera
- Microsoft Office
Knowledge Requirements
- EU GMP Annex 1
- US FDA cGMP
- WHO GMP
- ISPE Guidelines
- ASHRAE Standards
- ISO 14644 Cleanroom Standards
- Positive Engineering Practices (GEP)
- Risk Assessment (FMEA)
📌 Executive-Sr Executive - Engineering Projects (Telangana)
🏢 NA
📍 Telangana