Job Summary:
- Manage all aspects of production and operation of chamber from start to finish, so that it is completed on time and within budget; and
- Manage the maintenance, install, repair, start-up/commissioning, and operation of critical utilities and systems related to sterilization equipment and support systems, including steam boilers, hot water, chilled water, vacuum, and nitrogen system. Experience with industrial HVAC, plumbing and electrical a plus.
Responsibilities:
Maintenance
a. Oversee the routine Preventative Maintenance on sterilization equipment, and facilities HVAC, electrical and plumbing systems;
b. Troubleshoot critical utilities and systems related to sterilization equipment and support systems, including: steam boilers, hot water, chilled water, vacuum, and nitrogen system;
c. Troubleshoot and manage the maintenance and repair of the Sterilization building HVAC, electrical, lighting and plumbing systems;
d. Manages outside contractors during specialized projects and during routine services regarding sterilization equipment and support systems;
e. Project Manager for new equipment installation, equipment upgrades, building upgrades and improvements;
f. Perform validation on new equipment and processes (IQ,OQ, PQ, FAT);
g. Offers expertise in regard to continuous improvement, quality improvement, and cost reduction efforts related to sterilization equipment processes, support systems, and functions;
h. Coordinate annual equipment requalification;
i. Schedule and manage the annual plant shutdowns;
j. Manage the budget for projects spare parts and maintenance;
k. Assess spare part inventories to ensure adequate supply on-hand;
l. Perform calibration duties.
Production
a. To monitor and ensure that the sterilizer been operated in a safe manner at all time in accordance with the written rules and regulations;
b. To perform daily scheduling of customer products and liaise the day-to-day scheduling of the product processing to optimize the operation of the sterilizer;
c. Perform trouble shooting and repair of the sterilizer and its associated system together with engineering / production team;
d. Participate in recipe development for new products;
e. Planning and execute the training and retraining of maintenance technician/production/operation technician;
f. To assist QA in investigating all customer complaints and/or any nonconformance’s arise and to undertake appropriate action in order to prevent recurrence;
g. Authorize to ensure all chamber safety related issues are adhered at all times;
h. Developing and reviewing operating procedures to be used in service to enable it to meet the quality requirements at minimal cost;
i. Ensuring job cards, work schedules are prepared based on the priority of order to be processed;
j. Ensuring all requirements of Quality Management System based in the ISO 13485:2016 and other relevant standards are implemented and maintained;
k. Performing corrective action called for on an approved action request;
l. Ensure appropriate and timely delivery of service and products;
m. Participate (Lead) on the sterilization Emergency Response Team;
n. Comply with all local, state, federal, and safety regulations, policies, and procedures.
Others
a. Supervise departmental KPI to ensure the same are conducted and performed according to company’s policies and target.
b. Presentation of report(s) and working paper(s) for approval of Management / Board of Directors.
c. Monitor progress of subordinates from time to time and to guide them to perform effectively and efficiently.
d. Execute other responsibilities as and when directed by the Executive Director.
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