Research Triangle Park, North Carolina
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 QC LIMS Developer is accountable for support of the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, and scientific guidelines. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.
The LIMS developer is responsible for configuration, validation and ongoing maintenance within the LIMS platform. S/he will be expected to complete and review change requests, validate configurations, provide user support and troubleshoot as needed. S/he will be responsible to implement approved configuration changes within the LIMS platform as outlined in controlled change management records. The position will also be accountable to support documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.
This positon is responsible for ensuring that the LIMS system meets the requirements of the LIMS procedures. The LIMS Developer works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Work within the change management system update configurations for specifications, analyses and other static data within the Laboratory Information Management System (LIMS), as needed.
- Provide timely response to end user needs to include troubleshooting applications, creating new configuration templates, and maintaining change records in accordance with version control procedures.
- Provide LIMS training, technical support, problem reporting and resolution(s) to Quality Control laboratory, QA, AD and Manufacturing staff
- Develop, implement, and maintain Standard Operating Procedures, Work Instructions and training materials for the LIMS.
- Evaluate data generated and/or stored within the System to provide ad hoc and long-term reporting solutions that address business needs and identify process gaps that might otherwise go unnoticed.
- Collaborate with the LIMS team, IT department, and LIMS users to ensure new functionality meets user requirements.
- Write test scripts for new LIMS functionality and participate in the validation of new functionality releases.
- Revise supporting documentation for LIMS: SOPS, Design Specifications, Work Instructions and training materials
- Support the expansion of the LIMS platform through the preparation and execution of test scripts for system validation.
- Liaison with end-users in the Laboratory to ensure changes to configurations meet the needs of the end user.
- Revise or develop LIMS functional requirement specifications and user requirement specifications as well as other relevant documentation with guidance.
- Performs other related duties as assigned.
- B.S. degree in Computer Sciences, Information Technology, Biology, Microbiology, Biochemistry or other relevant scientific discipline (with hands on laboratory experience preferred)
- At least 4 years of experience with Labware LIMS development and/or working with a LIMS in a cGMP Quality Control department or in a FDA regulated industry (drugs/biologics)
- Experience with laboratory instrumentation, software and their interfacing is highly desired
- Thorough knowledge of cGMP/lCH/FDA regulations with 21 CFR Part 11 and GAMP knowledge a plus
- Experience with change control and software validation preferred
- Excellent oral and written communication skills
Specific Skills and Competencies
- 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, and plant personnel.
- Excellent verbal and written communication skills and attention to detail.
- Understanding of the pharmaceutical/biotech testing cycles or requirements.
- Technical writing and problem solving skills required.
- 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.