We are hiring a. Aseptic Vialing Technician. The Aseptic Vialing Technician will be responsible for final products process and vialing under aseptic conditions.
- 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 in a timely manner.
- Suggests changes in departmental Standard Operating Procedures (SOPs).
- Other duties as assigned by Lead or Supervisor.
- High school, Associates or equivalent
- At least 1 year of receiving warehouse experience
- General understanding of cGMP.
- Ability to speak, read, and write English.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to per essential functions.
- While performing the duties of this job, the employee is frequently required to stand. The employee is occasionally required to walk, sit, use hands to handle, feel, and reach, climb and/or balance, talk and hear.
- Job occasionally will require employee to work under cold or freezing temperatures for long periods of time.
- Specific vision abilities required by this job include close vision, and depth perception.
The work environment characteristics described here are representative of those an employee encounters18 while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- In course of job will be exposed to freezers and refrigerators with low temperatures. Required to wear jacket and safety equipment for freezers.
- The employee may be exposed to moving mechanical parts and risk of electrical shock.
- The employee is occasionally exposed to wet and/or humid conditions; fumes or airborne particles, toxic or caustic chemicals, biological materials.
- The noise level in the work environment is usually moderate to loud.
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.
In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, 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.
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.