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AD/AMT Instrumentation Specialist

Employer
FUJIFILM Diosynth Biotechnologies
Location
Research Triangle Park, NC
Start date
Sep 14, 2022

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Discipline
Clinical, Clinical Medicine
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC

Job Details

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We're growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you'll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We're proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDBU, you determine what's possible.

As we grow our community, our capacity, and capabilities, we're looking for passionate people to join our team. Our North Carolina site sits in the renowned Research Triangle Park, the United States' largest hub of research and innovation. In such a dynamic location adjacent to many of the country's best places to live, it's no surprise that our passion is meteoric.

External US

The AD/AMT Instrumentation Specialist will be responsible for ensuring AD/AMT instrumentation are on-boarded, updated as necessary, and compliant with Data Integrity standards in accordance with company policies and procedures.  This is a new role within the AD/AMT department at FujiFilm Diosynth Biotechnologies in RTP. The position will also be expected to liaise with facilities, engineering and IT to ensure the infrastructure is in place to support validation and / or integration of new and existing instruments and software, as well as to plan and execute bridging studies as needed to demonstrate assay performance on legacy and new instrumentation. The position will support the capital equipment budget process ensuring that the requirements of the labs are brought forward for new or replacement instruments.  The incumbent will have accountability to ensure that new or replaced instruments are on boarded such that their setup as well as their routine use meets the expectations of data integrity regulations.  As business and supporting systems grow, it will be the expectation that all instrumentation are integrated with the LIMS platform such that data are digitally captured real time and paper records are reduced.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Ensure the equipment and instrumentation needs across all disciplines of AD/AMT are identified and transparent.
  • Compile the instrumentation and equipment budget, ensuring it is a prioritized list for execution with end user and stakeholders.
  • Drive the deployment of instrumentation within AD/AMT with responsibility for all activities associated with onboarding new or replacing aged equipment.
  • Establish project plans for each instrument.  Proactively Identify risks to execution to the management team.  Manage each project for on time delivery, escalating risks as needed.
  • Where needed, support the validation activities ensuring that industry standards for validation, data integrity and instrument integration are applied.
  • The position will be expected to work cross functionally with the validation team onsite, employing the company and policies as applicable for the validation.
  • The incumbent will be able to work cross functionally with End Users, Engineering, and the Quality Assurance team.
  • Lead Data integrity assessments and remediation serving as the subject matter experts.
  • As a leader in the team it may be necessary to support the AD/AMT team periodically with PR management.

BACKGROUND REQUIREMENTS:

  • BS/MS in relevant Science or Engineering discipline, chemistry, biochemistry, pharmaceutical sciences, or related technical field.

Desired Experience

  • This position typically requires an MS degree and 1+ years of experience or a BS degree and 4+ years of experience in a cGMP pharmaceutical environment, preferably working directly with the implementation and support of analytical instrumentation. 

Specific Skills and Competencies

  • Hands on experience with analytical instrumentation associated with three or more of the following technologies: UPLC/HPLC (preferably using Waters Empower Software), capillary electrophoresis/imaged capillary isoelectric focusing (preferably using Waters Empower Software), gel electrophoresis/Western blot, plate based assays, qPCR, spectrophotometry, and mass spectrometry.
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
  • Capable of interfacing with multiple levels of people within the organization, including Corporate management, third party customers, and plant personnel.
  • Excellent verbal and written communication skills and attention to detail.
  • Thorough understanding of the pharmaceutical/biotech testing.
  • Proven ability to understand and implement data integrity standard and regulations
  • Previous experience with the validation of complex instrumentation in the Biotech / pharma environment.
  • Proven ability to conduct investigations, writing deviations and CAPA's
  • Superior technical writing and problem solving skills required.
  • Ability to put complex thoughts and issues into writing in such a manner than an educated, but uniformed reader can understand and make decisions based on the written investigation report
  • Ability to work cross-functionally with a diverse team.
  • Experience in Trackwise system preferred.

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 Company's 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.

Company

Company info
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States

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