Job Description

Department DetailsRole Summary"Primary responsibilities:
1. Execution of routine Re-validation of HVAC systems.
2. Coordinating and preparation of URS, DQ, IQ, OQ and PQ along with user and Projects.
3. Preparing of General and Preventive maintenance procedures and Equipment Checklist as per Vendor recommendations & Historical Data's.
4. Documentation - Handling of change controls, SOP's, deviations, CAPA, training records, Protocols etc.
5. Preparing of drawings & layouts.
6. Witnessing of validation activities for new projects and modification works.
7. Coordinating and conducting training sessions with QA and EHS for team members.
8. Coordinating for implementation of RCM/D-FMEA/P-FMEA.
9. Coordinating for SMED identification for Skill set/ Time bond for execution of PM.
10. Preparation of Procedures for AMC to make in line with Vendor Procedure.
11. Preparation of Pre-Audit Requisites and coordinating for Internal/External audits and Timely response.
12. Monitoring of EMS system and Water Plant system.
13. Documentation and data control for Water plant and EMS system log sheets and checklist as described in the SOP's
14. Performing the Preventive maintenance for process and Utility Equipment's and documenting the preventive maintenance checklists and Planner for process and Utility Equipment's.
15. Coordinating for handling breakdown maintenance for process and Utility Equipment's and ensuring timely closure of the issue with adequate measures.
16. Responsible for up keeping the Process equipment by coordinating with cross functional team.
17. Coordinating for the preparation of Critical spare parts for the process and Utility Equipment's.
18. Responsible for ensuring the addressing and timely closure of complaints and generating reports in SAP.
19. Responsible for Ensuring Good Engineering Practices and to comply with audit compliance, safety and Productivity.
20. Adherence to standard operating procedures, Safety, cGMP and EHS requirements.
21. Coordinating with vendor for carrying out activities related to statutory compliance and ensuring timely completion.
22. Responsible to handle Fermenter, Continoues centrifuge, Homogenizer, Chromotography system, Chromotography column, Temperature control unit, mobile tanks, Over head stirrer and BSC , etc
Secondary Resposnibilities:
1. Review on Effectiveness of PM/Breakdown/CAPA and coordinating for the updation of Procedures/Frequency revision, so as to increase the Equipment reliability.
2. Monitoring of HVAC, EMS, BMS and water plant.
3. Energy Management in the area.
4. Review the daily monitoring documents.
5. Coordinating the AMC activity with vendor.
6. Coordinating for the preparation and updation of Electrical drawingsKey Responsibilities"Primary responsibilities:
1. Execution of routine Re-validation of HVAC systems.
2. Coordinating and preparation of URS, DQ, IQ, OQ and PQ along with user and Projects.
3. Preparing of General and Preventive maintenance procedures and Equipment Checklist as per Vendor recommendations & Historical Data's.
4. Documentation - Handling of change controls, SOP's, deviations, CAPA, training records, Protocols etc.
5. Preparing of drawings & layouts.
6. Witnessing of validation activities for new projects and modification works.
7. Coordinating and conducting training sessions with QA and EHS for team members.
8. Coordinating for implementation of RCM/D-FMEA/P-FMEA.
9. Coordinating for SMED identification for Skill set/ Time bond for execution of PM.
10. Preparation of Procedures for AMC to make in line with Vendor Procedure.
11. Preparation of Pre-Audit Requisites and coordinating for Internal/External audits and Timely response.
12. Monitoring of EMS system and Water Plant system.
13. Documentation and data control for Water plant and EMS system log sheets and checklist as described in the SOP's
14. Performing the Preventive maintenance for process and Utility Equipment's and documenting the preventive maintenance checklists and Planner for process and Utility Equipment's.
15. Coordinating for handling breakdown maintenance for process and Utility Equipment's and ensuring timely closure of the issue with adequate measures.
16. Responsible for up keeping the Process equipment by coordinating with cross functional team.
17. Coordinating for the preparation of Critical spare parts for the process and Utility Equipment's.
18. Responsible for ensuring the addressing and timely closure of complaints and generating reports in SAP.
19. Responsible for Ensuring Good Engineering Practices and to comply with audit compliance, safety and Productivity.
20. Adherence to standard operating procedures, Safety, cGMP and EHS requirements.
21. Coordinating with vendor for carrying out activities related to statutory compliance and ensuring timely completion.
22. Responsible to handle Fermenter, Continoues centrifuge, Homogenizer, Chromotography system, Chromotography column, Temperature control unit, mobile tanks, Over head stirrer and BSC , etc
Secondary Resposnibilities:
1. Review on Effectiveness of PM/Breakdown/CAPA and coordinating for the updation of Procedures/Frequency revision, so as to increase the Equipment reliability.
2. Monitoring of HVAC, EMS, BMS and water plant.
3. Energy Management in the area.
4. Review the daily monitoring documents.
5. Coordinating the AMC activity with vendor.
6. Coordinating for the preparation and updation of Electrical drawingsEducational QualificationsRequired Education Qualification: B.Tech
Required Experience: 2 - 5 years

Biocon