Roles and Responsibilities:

1. Lead team of engineers / duty technicians covering utilities and facilities for the pharmaceutical manufacturing site.

2. Working experience in Pharmaceutical / Biologics cGMP manufacturing facility would have added advantage.

3. Ensure the site's facilities are kept to the highest standards for cGMP requirements, including Purified water system, HVAC system, EMS, BMS, Boilers, chillers, cooling towers, fire safety, security, pest control as applicable, cleaning services and waste removal.

4. Experience in handling clean utility equipment (example autoclave, WFI etc) would be an added advantage.

5. Responsible for utilities equipment Operation, breakdown and Preventive Maintenance, Calibration, spares management and drawings management. Expecting to improve the troubleshooting skills for technicians to minimize the overall maintenance cost for utilities.

6. Planning and execution of all new and retrofit projects related to utilities as required.

7. Work with all departments within the facility effectively to assure facility is the state of compliance and objectives are accomplished.

8. Ensuring the best available technologies are incorporated by design. Measures the efficiency of energy usage in the facility.

9. Technical commercial evaluations of consultants, vendors, and contractors.

10. Delivering the project within the budget and timeline approved.

11. Responsible for relevant project costing and annual budget preparation related to Utilities and its maintenance. Achieve financial objectives through efficient utility operation, cost improvement actions and optimal cost options.

12. Coordinating with statutory authorities for relevant approvals.

13. Complying with operational and personnel standards, regulatory and statutory requirements to ensure efficient, reliable, and uninterrupted operation.

14. Ensure smooth handing over of the project to end-users, coordinate and ensure deliverables as per plan.

15. Responsible for development SOPs and quality standard for site with following of site QMS procedures.

16. Ensure to meet all relevant regulatory requirements (e.g. HSA, FDA, EMEA etc.) and keep site audit ready all the time.

17. Responsible for managing a team of vendors / contractors.

18. To assist on any ad-hoc duties that been assigned / task by the immediate superior.

Qualification:

1. Bachelor’s degree in engineering; acceptable disciplines include mechanical engineering, electrical engineering, or industrial engineering or Diploma in Engineering with a minimum of 5 -10 years of relevant experience.

2. Working Experience on SAP / Track wise to Initiate Purchase orders, change controls, deviations and appropriate CAPA/task would be an added advantage.

3. SCEM would be an added advantage.