Manager Engineering - Skid SME

Role & responsibilities

1. Responsible for maintenance management (Breakdown and PM) for all Mfg. Skid available at site.

2. knowledge about Mfg. and Filtration process of Complex skid.

3. knowledge about complete process from raw material sampling / dispensing to finish good (Sampling / dispensing / Mfg. / Filtration / Filling / Capping / Packing)

4. knowledge about selection of material for Mfg. and filtration skid based on product / Chemicals.

5. knowledge about instrumentation and operation of component installed on skid.

6. knowledge about critical component like. Block valves, Magnetic mixtures, Transfer pumps, Mfg. Vessel, Weighing system during design of Mfg. and filtration skid.

7. knowledge about control system of the Skid. PLC, SCADA, IPC. Zone 1 & 2 Safety guidelines.

10. should have knowledge of installation commissioning of Mfg. Skid.

handled complex Mfg. and Filtration skid.

12. should be able to communicate to cross functional team (Quality, MSTG, R&D & Production)

13. knowledge about Filling line equipments (Washing / Depyrogenation tunnel / Filling / Freeze Dryer / Capping /Leak testing / Inspection / X-ray).

14. should have knowledge about quality management system (QMS) like. Change control, CAPA, Unplanned Deviation, Investigation.

15. should have knowledge about maintenance management (Breakdown and PM) of all equipments.

16. should be able to prepare SOPs of Operation and maintenance of equipments.

17. should have knowledge about calibration activities of instruments.

18 should be able to handle third party vendors during day to day activities and installation of equipments.

19. should have knowledge about Execution, Documentation and coordination with third party vendor for CSV and PCS (Process Control System) Qualification & Validation.

20. should have knowledge about SAP system for PM, Calibration and Breakdown Maintenance.

21. should be managed critical spares of Skid like. Seals, Pumps, Magnetic mixture, Valves, Sensors etc..

22. should be able to train the operator and engineers who area working on complex Skid.

23. should be able to handle Project work related to Digitization, Automation and up gradation of systems and equipment.

24. To ensure safety standards are maintained at site. To ensure safety procedures are available at site and followed strictly in accordance to relevant regulations.

25. should be able to do technical coordination with procurement team and follow up with vendor for material and project / service work.

26. ensure GMP Documents are maintained as per SOP.

27. ensure that timely compliance of internal and external audit observation points.