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Senior Cleaning Validation Engineer

Employer
FUJIFILM Diosynth Biotechnologies
Location
Research Triangle Park, NC
Start date
Sep 15, 2022
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Job Details

The Senior Cleaning Validation Engineer is a high-level position in the MT&S department of FDBU. In this position you will provide on the floor support developing automation methods, working directly with clients, working with chromatography/filtration systems and acting as the Subject matter expert for the role. 

External US

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 FDB, you determine what's possible.

 

The  Senior Cleaning Validation Engineer is a high-level position in the MT&S department of FDBU.  In this position you will provide on the floor support cleaning validation, interact directly with clients, support  client/Board of Health audits, working withal Upstream and Downstream   systems and acting as the Subject matter expert for the role. 

 

Primary Responsibilities include:

  • Authoring, executing, summarizing Cleaning Validation protocols.
  • Authoring Annual Cleaning Report
  • Overseeing Annual Cleaning Requalifications for Commercial Programs
  • Performing MACO calculations to support incoming programs.
  •  Reviewing Potent Molecule Degradation Studies to ensure methods are appropriate for manufacturing equipment/facility
  • Design/manage Disinfectant Efficacy Studies
  • Participate in Client/Board of Health audits
  • Support manufacturing facility/equipment investigations
  • Developing/revising SOPs to support facility/equipment cleaning
  • Support cleaning program process improvements/efficiencies
  • Perform assessments of new technologies
  • Support cleaning cycle development
  • Work under minimal supervision on complex projects and may assist/direct less experience peers

BACKGROUND REQUIREMENTS:

Education/Experience:

  • B.Sc. degree in Life Sciences/Engineering and 5-8+ years of relevant experience.

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.

 

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

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.

Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.

Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.

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Find Us
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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