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上海市, 中国
Hybrid
· Provide service support, including repair and preventive maintenance, for equipment and document all service activities at customer sites.
· Work in accordance with company SOP’s and according to Repligen’s quality system.
· Ability to follow established SOP’s and procedures regarding execution of tasks as well as administrative operations.
· Complete product and SOP training on a regular basis and in a timely manner.
· Perform installation and training on equipment, software, and other accessories; report back on issues, orders and parts needed.
· Perform Site Acceptance Testing (SAT) and IOQ on Repligen products at customer sites within APAC and occasionally globally.
· Support Factory Acceptance Testing (FAT) performed in the USA or in Europe remotely (or occasionally in person) during the matching time zone of the FAT location.
· Perform installation, preventative maintenance, IQOQ/SAT and repairs on all Repligen equipment as required.
· Provide support and input for scheduling the on-site service activities.
· Problem-solving tasks may include resolving mechanical/electrical/software issues; resolving operating system bugs; and reinstalling software or hardware.
· Enhance the customer’s positive experience by recognizing their needs and providing solutions that meet and often surpass those needs.
· Communicate effectively both internally and externally, to document actions and items performed, schedule future preventive (maintenance) needs, and other engineering functions.
· Provide technical support to colleagues from other departments globally.
· Create leads and discuss business opportunities with the customer.
· Proactively work together with the service sales team to create Service Level Agreements with customers.
· Increase service sales and provide support to colleagues from other departments in order to increase sales.
· Promote new Repligen Service products with customers and provide leads to the sales team.
· Provide phone support to customers and service group personnel related to equipment hardware and software performance and spare part ordering.
· Document and distribute technical information regarding resolutions to field problems, hardware and software changes, and product quality improvements.
· Review service manual documentation to ensure accuracy and current revision levels.
· Determine appropriate preventive maintenance procedures, service parts kits, and schedules to ensure effective on-going equipment maintenance.
· Keep the workplace clean and tidy, both at the customer site and in office.
· Involve or lead projects and assignments as part of the professional development opportunity.
· Work with the Associate Director of Field Service, APAC to help schedule service visits for the China FSE’s and ensure workload is well divided.
· Control travel cost and expenses in an efficient manner.
· Work with the Associate Director of Field Service, APAC to ensure China FSE’s complete all administrative tasks (salesforce, service report, controlled documentation, …) for all field service visits.
Education, Training & Experience
· A bachelor’s degree or higher in Electronics, Electro-mechanics, Automation or related discipline.
· At least 8 years’ experience in the repair, maintenance, and installation of equipment used in a scientific instrument, laboratory, or bioprocess setting or in the biotechnology sector, ideally experienced with filtration equipment
· Strong knowledge of cGMP and GDP
· Electronic and mechanical aptitude required
· Experience with CSV (computer system validation)
· Understanding of GAMP regulations and US FDA 21 CFR Part 11 compliance
· Ability to understand automation architecture, IO List, electrical schematics, SDS, HDS and FDS documents
· Experience with Salesforce Lightning is a plus.
· Software and Automation familiarity required:
o Siemens S7
o Siemens Wincc
o Dreamreports
o iFix
o Allen Bradley RSLogix
o Wonderware / Intouch
o SQL
o Historian
o Emerson DeltaV (up to version 16 or version 17 ideally)
Licensure & Certification
· Driving license
· International Passport with ability to travel within APAC and EU/USA.
Knowledge, Skill, and Ability
· Ability to draft and execute SOPs and work instructions.
· Self-learning ability, resourcefulness and creativity to resolve complex problems in the field