JOB SUMMARY
The Field Service Engineer 3 (FSE 3) is responsible for installing, maintaining, and servicing Repligen systems; ATF, TFF, Chromatography and Analytical systems throughout China and occasionally other countries within the general Asia-Pacific region.
The FSE 3 is to provide remote and onsite support and troubleshoot technical issues by working closely with the local sales team and product managers /customer service, complaints, service support located in the APAC, USA and Europe.
The FSE 3 will also assist in scheduling services in China and ensure compliance with the global guidelines, as well as support service sales and work with the internal sales team in providing quotes.
- 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
- International Passport with ability to travel within APAC and EU/USA.
Knowledge, Skill, and Ability
- Excellent interpersonal skills, strong verbal/written communications skills.
- Great attention to detail in work and documentation
- Good administrative skills
- Strong problem solving and analytical skills
- Ability to prioritize and work independently to achieve defined goals
- Ability to work well within a global, cross functional team
- Must be willing and able to work flexible hours to accommodate different work schedules even outside of office hours.
- Ability to draft and execute SOPs and work instructions.
- Self-learning ability, resourcefulness and creativity to resolve complex problems in the field
- Able to travel extensively within countries in Rest of Asia and globally.
- Able to work long hours in cleanroom environment.
- Able to lift and carry weights (including equipment and toolbox) individually of up to 25kg.
