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1、Assist in the establishment and improvement of equipment data files, responsible for the daily affairs of equipment management.
2、Assist in the establishment of equipment management quality system, and strict implementation, to ensure the effective operation of the equipment normal.
3、Responsible for equipment maintenance, maintenance, to ensure the safe operation of the company's equipment (liquid preparation, bioreactor, centrifuge, chromatography, purification, preparation, etc.).
4、Responsible for equipment maintenance annual plan and implementation.
5、Responsible for equipment repair and maintenance with spare parts statistics and requisition.
6、Cooperate with EHS audit, GMP audit and daily audit, and implement rectification according to the schedule of rectification plan found.
7、Responsible for the management of quality changes and deviations in the process of operation and maintenance.
8、Assist in the preparation of URS for the introduction of new equipment.
9、Complete other work assigned by superiors.
10、Writing and preparing work plans, reports, budgets, etc. for the areas under responsibility.
1、College degree or above, majoring in electrical automation, mechatronics and other related majors.
2、More than 2 years of experience in biopharmaceutical plant equipment; familiar with equipment management, maintenance and improvement; new construction experience is a plus.
3、Familiar with biopharmaceutical production equipment, can reasonably arrange the maintenance and repair work of equipment.
4、Able to independently prepare SOPs and checklists.
5、With electrician and welder certificate is preferred.