Group Leader - Engineering (DP Process Equipment)

OneSource Specialty Pharma; Bengaluru; On-site; INR 800,000 - 1,100,000; Full time

Job summary

OneSource Specialty Pharma in Bengaluru, India is seeking a Plant Maintenance & Operations professional to oversee strategic upgrades and ensure adherence to cGMP and management targets.

The role covers preventive and breakdown maintenance of filling lines, autoclaves, isolators, and associated equipment, coordination with HVAC, SOPs, energy audits, spare parts planning and ensuring smooth plant operations.

Responsibilities

• 1. Plant upgradation works planning, execution on periodical basis.
• 2. Plan & work towards the target set by the management based on business needs.
• 3. Updated & aware of cGMP requirements.
• 4. Handling DP process equipment preventive maintenance & breakdown maintenance: Integrated filling lines of cartridge, Vial & PFS with isolators, Autoclaves, packing lines, CIP, SIP skids, glass ware washers, Pass boxes, cold rooms, LAFs, HSV line, etc.
• 5. Coordination with HVAC team & ensure requirements in the process area is as per requirements.
• 6. Preparation of SOP, Preventive Maintenance schedule/planner, Documentation etc.
• 7. Knowledge of plant safety & cGMP requirements.
• 8. Coordination with user departments & plan for Preventive/Breakdown maintenance.
• 9. Ensure smooth operation of plant & machinery to avoid breakdowns & production loss.
• 10. Plan for required spare parts inventory & AMC.
• 11. Manpower planning & reporting.
• 12. To conduct Periodical energy audits to improve the efficiency of the system & to bring down the operating cost.
• 13. To take care of shift operations and attend to breakdowns.
• 14. Prepare/Review/Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ.
• 15. Audit & Statutory Compliance.
• 16. Computer skills including EMDS, SAP (PM Module), E- Val genesis system

Job description

Job Responsibility:

STRATEGIC:

1. Plant upgradation works planning, execution on periodical basis.

2. Plan & work towards the target set by the management based on business needs.

3. Updated & aware of cGMP requirements.

OPERATIONAL:

4. Handling DP process equipment preventive maintenance & breakdown maintenance: Integrated filling lines of cartridge, Vial & PFS with isolators, Autoclaves, packing lines, CIP, SIP skids, glass ware washers, Pass boxes, cold rooms, LAFs, HSV line, etc.

5. Coordination with HVAC team & ensure requirements in the process area is as per requirements.

6. Preparation of SOP, Preventive Maintenance schedule/planner, Documentation etc.

7. Knowledge of plant safety & cGMP requirements.

8. Coordination with user departments & plan for Preventive/Breakdown maintenance.

9. Ensure smooth operation of plant & machinery to avoid breakdowns & production loss.

10. Plan for required spare parts inventory & AMC.

11. Manpower planning & reporting.

12. To conduct Periodical energy audits to improve the efficiency of the system & to bring down the operating cost.

13. To take care of shift operations and attend to breakdowns.

14. Prepare/Review/Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ.

15. Audit & Statutory Compliance.

16. Computer skills including EMDS, SAP (PM Module), E- Val genesis system