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Production Technician I

2 months ago

Durham, United States FUJIFILM Corporation Full time

Overview:

Fujifilm Diosynth Biotechnologies, U.S.A., Inc. is seeking a Production Technician I. The successful candidate will execute production processes as well as the accompanying documentation.

External US:

Main areas of responsibilities include:

  • Executing development and production processes as well as process documentation
  • Understanding processing principles and scientific theory behind operations steps
  • Demonstrating proficiency at the advanced skill level
  • Troubleshooting of equipment/processes
  • Authorizing and routing SOPs for approval
  • Assisting in the execution of validation protocols
  • Initiating deviations as needed
  • Independently executing cGMP biotechnology production processes, training and directing lesser skilled employees to execute production process steps
  • Assisting with lean continuous improvement projects
  • Leading others in application of cGMPs for manufacturing documentation, facilities, and equipment in a biotechnology environment
  • Demonstrating a commitment and leading others to maintain high standards of quality, cleanliness, and organization within the manufacturing environment

ORGANIZATIONAL STRUCTURE:

This position reports to the Production Manager and has no direct reports.

SCOPE MEASURES:

Work Experience:

  • Associate achieves skill block within 9-36 months

FDBU Standards:

  • Knowledge of applicable standards (SOP, WI, Batch Records) cGMP Requirements, and Related Safety Guidelines

Process Operation:

  • 2-26+ Skill Points

Troubleshooting & Process Improvement:

  • Identifies and escalates operational or equipment issues

Communication & Record Keeping:

  • Records (accurately, clearly and consistently) information, facts, and measurements that are required by cGMP and/or by co-workers in order to perform his/her assignment
    Communicates effectively, both verbally and written, with colleagues regarding daily production activities

Required Education, Experience and Skills Minimum Requirements:

  • High School Diploma or equivalent
  • BioWorks certificate or at least 1 year experience
  • Must be able to wear a respirator

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 130 and Export Administration Regulations in 15 C.F.R. Part 730 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Companys ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com

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.