Team Lead-Engineering (Process Maintenance) Vaccine Division
Experience-15-20 Yrs
Qualification-B.Tech./MTech. (Electrical/Mechanical/instrumentation)
- Review and controlling the plant operations, quality, maintenance, cost and safety indicators and resource management
- Managing engineering/utility resources for utility equipment operations and plant maintenance tasks.
- Compliance of Preventive/Breakdown and Calibration procedures. Ensure effective Maintenance.
- Review and approving of plant and machinery maintenance/Calibration related planners and ensuring compliance of the same.
- Supporting the area revalidation and ensuring the meeting the standards and timelines.
- Ensuring SOP training compliance for all employs
- Review and recommendation of external service supporters for regular and specialized maintenance.
- Ensuring Conflict resolution in technical operational issues.
- Ensuring team GMP practices in operating and supporting area.
- Monthly/yearly budget planning and ensuring spending with in approval.
- Identifying, planning, and carrying out ideas for resource optimization and energy conservation.
- Maintaining facility for Compliance with cGMP, EHS, Regulatory requirements.
- Assisting/leading for statutory compliance- GIDC, UGVCL, GPCD etc.,– as needed.
- Maintaining- Spares/Consumable inventory and operating engineering stores.
- Co- coordinating with QA/CQA for assessing the CAPAS and improvements plans and horizontal deployment.
- Ensuring the Energy index is in line with Plant KPIs.
- Digitization - Equipment assessment, buy ins- simplification, compatibility, vendor assessment
- Breakdown analysis, report and recommendations for improvement in regular PMs.
- Lead the team and provide the support to develop individuals.
- Act as a User from engineering discipline and providing inputs/URS for new projects in Pipeline and assisting for Qualifications.
- Ensuring the appropriate closure and transfer of project and re conciliation of material to Operations/Maintenance.
Preferences.
- Technical knowledge on working/maintenance of
- Liquid filling line
- Isolators
- Lyophilizer
- Sterilization equipment (Autoclaves/Terminal sterilisers/vessels)
- Clean utilities. (PW,WFI, PSG)
- Inspection/labelling machines.
- Cold chine equipment (Cold rooms, Deep freezers etc)
- Clean room equipment /HVAC system. (Down side)
- Main utilities – Water treatment, Chillers, Compressor, Driers.
- Good understanding sterile process requirement. (process and quality needs)
Good to have
- Bioprocess equipment
- AutoCAD.
- SAP
- Track wise.
