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CSV Engineer

Company: FUJIFILM Diosynth Biotechnologies
Location: Holly Springs
Posted on: January 21, 2023

Job Description:

The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are 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 manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki. Join usWe are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. The Computer Systems Validation (CSV) Engineer is responsible for supporting compliance related to computerized systems via the creation, review, and execution of validation documentation and protocols for IT systems with applicable regulatory and cGMP guidelines.The CSV Engineer will provide IT systems validation and compliance expertise for the various systems across the new site. This position will work within a collaborative team and will be required to have excellent verbal and written communication skills. This position requires basic knowledge of IT infrastructure hardware, software, and FDA regulation 21 CFR Part 11. This position will report directly to the Project Head - Information Technology but may also have a functional reporting relationship to a senior colleague on a project-to-project basis. External US Responsibilities

  • Assist with the development of system requirements and specifications to ensure requirements that are testable and meet 21 CFR Part 11.
  • Develop and execute computer systems validation plans, test protocols, traceability matrices, release reports, and all documents and deliverables within the scope of the IT Master Validation Plan.
  • Collaborates with other FDB sites to share CSV best practices
  • Conform to all cGMP requirements for documentation and data integrity.
  • Works with project managers to include validation activities in implementation timelines
  • Solves protocol execution issues using critical analysis and develops sound, reasonable solutions
  • Develop, revise, and abide by Standard Operating Procedures (SOPs) and engineering documents.
  • Performs Data Integrity and 21 CFR Part 11 assessments
  • Performs validation activities associated with Quality investigations
  • Able to interface and build collaborative partnerships with multiple site functions including Manufacturing, Technical Operations, Engineering, and Quality to deliver site goals and objectives
  • Other duties as assignedRequirements
    • Bachelor's degree in Computer Science, Engineering, or other STEM field or 5+ years' equivalent experience in a regulated work environment
    • Good knowledge of FDA regulation 21 CFR Part 11 requirements, ER/ES and data integrity guidelines
    • Basic knowledge of IT infrastructure, process control, and software systems in a regulated manufacturing facility
    • Excellent organizational, verbal, and written communication skills with the ability to effectively communicate within cross-functional teams and to management
    • Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
    • Self-starter and detail oriented
    • Ability to manage commitments while displaying an eagerness to learn and continuously improve
    • Excellent presentation skills with the ability to clearly articulate sound reasoning and data when recommending courses of action
    • Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-IT personnel
    • TrackWise experience is a plusFDBN 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.FDBN 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 email .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.

Keywords: FUJIFILM Diosynth Biotechnologies, Cary , CSV Engineer, Engineering , Holly Springs, North Carolina

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