Aseptic Filling Technician, 2nd shift

Company: FISI - FUJIFILM Irvine Scientific
Location: Santa Ana
Posted on: March 17, 2023

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 an Aseptic Filling Technicians - 2nd shift. The Aseptic Filling Technician performs sterile filtration and filling, and sterilizes filters, containers, and closures. In addition, this person will be responsible for cleanroom set-ups and integrity testing of filters.**













External US









Responsibilities:

• Prepare and set-up aseptic filling/filtration equipment in a cleanroom environment
• Follow Aseptic-filling procedures while using manual or automated filling systems to fill various liquid media products
• Follow proper cleanroom behavior and gowning procedures
• Maintain and ensure completeness and accuracy of all cleanroom documentation
• Perform room and equipment cleaning per current procedures; maintains the cleanroom in an organized fashion following 6S principles
• Ensure that required supply items such as gloves, wipes, alcohol, etc. are well stocked in their designated areas of the cleanroom; responsible for ordering additional supplies or informing the Lead or Supervisor that additional supplies are needed
• Complete filter integrity testing in a timely manner
• Ensure that all cleaning procedures are properly followed
• Perform container/component staging as needed
• Obtain and label QC samples as required
• Complete necessary filling documentation in a timely manner
• Suggest changes in departmental Standard Operating Procedures (SOPs)
• Other duties as assigned by Lead or SupervisorExperience/ Education:
  • High School Diploma or equivalent required
  • Minimum one year as certified aseptic filling technician.
  • Experience must include manual and automated aseptic fill systems.
  • Certification in ISO 5 environment cleanroom gowning.
  • Good, stable work history
  • Knowledge of metric system and its unit conversions.
  • Knowledge of aseptic techniques
  • General understanding of Good Manufacturing Practices (GMPs)For California, the base salary range for this position is $18.00 to $29 hourly. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).FUJIFILM 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.If COVID-19 -vaccine is mandated by the federal government, or by state or local government, the Company -will -require that the successful candidate hired for positions -covered under relevant government vaccine mandate(s) -be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. - For all -positions, the Company -encourages vaccination against COVID-19 and -may require that the successful candidate hired be willing to test for the COVID-19 virus -periodically -and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. - -
    
    
    
    

Keywords: FISI - FUJIFILM Irvine Scientific, Santa Ana , Aseptic Filling Technician, 2nd shift, Professions , Santa Ana, California