Team Lead - Engineering (DP Process Equipment)

OneSource Specialty Pharma; Bengaluru; On-site; INR 600,000 - 900,000; Part time

Job summary

OneSource Specialty Pharma in Bengaluru is seeking a Maintenance Engineer to oversee plant upgradation projects and ensure adherence to cGMP standards. You will plan and execute preventive maintenance, coordinate with HVAC and other user departments, and prepare SOPs and documentation to support uninterrupted production.

The role requires hands-on management of equipment such as filling lines, autoclaves, CIP/SIP skids, and related systems, with energy audits to reduce operating costs and ensure

Responsibilities

• Plant upgradation works planning and execution on a periodic basis.
• Plan and work towards targets set by management based on business needs.
• Ensure compliance with cGMP requirements.
• Handle DP process equipment preventive and breakdown maintenance: integrated filling lines with isolators, autoclaves, packing lines, CIP, SIP etc.
• Coordinate with HVAC team to ensure process-area requirements.
• Prepare SOPs, preventive maintenance schedules, and documentation.
• Knowledge of plant safety and cGMP requirements.
• Coordinate with user departments for preventive or breakdown maintenance.
• Ensure smooth operation of plant and machinery to avoid breakdowns and losses.
• Plan for spare parts inventory and AMC.
• Manpower planning and reporting.
• Conduct periodic energy audits to improve efficiency and reduce costs.
• Manage shift operations and attend to breakdowns.
• Prepare/review/execute SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & PQ support.
• Audit and statutory compliance.
• Knowledge of 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