Overview
The Aseptic Filling Technician is responsible for final products process and vialing under aseptic condition. It is also responsible for small-scale sterile filtration, lyophilization and vialing operation.
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, 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 ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide 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.
External US
Responsibilities:
- Prepare and set-up aseptic filling/filtration equipment in a cleanroom environment.
- Follows Aseptic-filling procedures while using manual or automated filling systems to fill various liquid media products.
- Follows proper cleanroom behavior and gowning procedures.
- Ability to disinfect controlled (cleanroom, formulation) areas, controlled not certified (CNC) and support environments in compliance with SOP.
- Perform cleanroom support tech activities- includes but not limited to room/ station set up and associated batch set up.
- Maintains and ensures completeness and accuracy of all documentation associated to work performed.
- Ability to navigate through electronic documentation system. Document vialing activities performed in vailing batch record.
- Responsible for transactions associated with components and supplies used for batch; to maintain inventory accuracy.
- Follow line clearance requirements to maintain cGMP and cGLP in all work areas.
- Follows all safety procedures and works in a safe manner including wearing all required personal protective equipment.
- Performs room and equipment cleaning per current procedures. Maintains the cleanroom in an organized fashion following 6S principles.
- Ensures 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.
- Completes filter integrity testing in a timely manner.
- Ensures that all cleaning procedures are properly followed.
- Performs container/component staging as needed.
- Obtains and labels QC samples as required.
- Completes necessary filling documentation (log books, batch records etc.) in a timely manner.
- Suggests changes in departmental Standard Operating Procedures (SOPs).
- Other duties as assigned by Lead or Supervisor
Required Skills/Education:
- HS Diploma; Associates or equivalent (preferred)
- At least 1 – 2 year of aseptic filling experience.
- Experience in the hands-on use of equipment and processes to manufacture sterile products
- Experience visually inspecting life science products
- Experience operating analytical balances
- Good pipetting techniques
- Working with SAP or any other ERP system
- Knowledge of labelling software like Bartender is preferable
- Manual Pipetting experience preferred
Desired Skills (Hiring Manager complete):
- Worked in lab scale or commercial operation of low volume filling operation
- Experience in working with Biological safety hood
EEO/AGENCY NOTES
Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by 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.
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