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Technical Support Specialist - Single Use Technology (SUT)

Company: FISI - FUJIFILM Irvine Scientific
Location: Santa Ana
Posted on: November 22, 2021

Job Description:

Overview FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company's consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. - FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.We are hiring a Technical Support Specialist - Single Use Technology (SUT). The Technical Support Specialist will perform pre and post-sales support of scientific instruments, along with installation and service of equipment at customer sites. The person in this role will be responsible for supporting new sales at targeted accounts, as well as expansion and maintenance of existing customers in order to achieve departmental and corporate plan.** External US Responsibilities:

  • Serve as primary internal support technician for FAS and Technical Sales Specialist for the installation, validation training and troubleshooting of automated, single-use equipment for biopharma and cell/gene therapy customers
  • Have detailed knowledge of the equipment functions, as well as operating and maintaining the equipment
  • Support FAS on technical product discussions with customers
  • Support customers to analyze and troubleshoot issues to determine source of problems, and recommend solutions or other corrective actions
  • Document troubleshooting and problem resolution steps
  • Take ownership of technical issues, and work with the MSAT group to resolve more advanced issues when necessary
  • Collect information from the field on process mapping to convey customer needs internally
  • Help to write and or Review customer User Requirements Specifications (URS) and product specifications to align with the single use offering; Collaborates with internal teams on product opportunities
  • Create solutions to overcome customer's potential and actual challenges
  • Support FAS on FAT, SAT and Installation and operational Qualification activities at customer sites for bioprocessing equipment
  • Participate in providing training as required
  • Act as a point of contact for the marketing and sales organizations in collecting market trends, competitive information and other relevant business information
  • Support the sales process for service/s and maintenance agreements
  • Create and execute documentation to support validation cycle
  • Adhere to the correct safety procedures and ensure the safety of yourself and others
  • Other duties may be assigned as neededExperience/ Education:
    • Bachelor's degree in Electronics, Software Engineering, Engineering, or equivalent required
    • 3-5 years hands-on experience managing and troubleshooting equipment in bioprocessing
    • Detailed working knowledge of single-use systems and technologies
    • Working knowledge of process development technologies
    • Experience in media development in biopharma, cell & gene therapy and vaccine manufacturing
    • Knowledge of cGMP & regulatory standards for biopharma manufacturing
    • Proven experience of SAT, Installation Qualification and post-sales customer support on equipment URS
    • Experience in translating customer requirements into specific control and data-acquisition solutions
    • Knowledge of (Allen Bradley Siemens, Delta V ) PLC Systems
    • Broad experience on communication protocols for data exchange with a PLCs and BMS
    • Knowledge of GAMP/GMP and software validation specifically 21 CFR part 11/ Annex 11
    • Basic knowledge of mechanical engineering and hardware troubleshooting
    • Works in a structured, results-oriented manner, willing to contribute with ideas and a hands-on approach
    • Has an outstanding customer service mentality
    • Works well independently and within an interdepartmental team
    • Able to deal with shifting priorities and deadlinesFUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic -protected by applicable federal, state, or local law.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: FISI - FUJIFILM Irvine Scientific, Santa Ana , Technical Support Specialist - Single Use Technology (SUT), IT / Software / Systems , Santa Ana, California

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