The work we do at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 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 FDBU 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 FDBU calls Genki.
Laboratory Engineer II is a mid-level position in the Laboratory Engineering department of FDBU. This position will directly report to the Senior Manager Operations Support, Engineering, but may also have a functional reporting relationship to a senior colleague on a project-to-project basis. This position will deliver the planning and execution of small and medium projects in support of Lab QC equipment and systems.
External USEssential Duties and Responsibilities
Interface and build collaborative partnerships with key site functions including Manufacturing, Technical Operations, Engineering, and Quality to deliver site goals and objectives.Actively support QC Lab requests and engineering projects.Maintain and support manufacturing QC systems.Maintain 100% customer satisfaction for all technical support calls.Provide hands-on diagnostic/troubleshooting support for QC process and monitoring systems.Support the design and implementation of sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBU standards and cGMP regulatory requirements while following GAMP guidelines.Support capital projects from conception, design and initial specifications through completion and turnover.Develop/Revise User Requirement Specifications, Functional Specifications, Design Specifications, SOPs and Guidelines for new and existing QC systems.Lead, support, and perform investigations relating to complex manufacturing and QC deviations and anomalies associated with QC systems and control system software in order to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrenceDemonstrate basic skills with high level of proficiency in administrative workDemonstrate an understanding of GMPS, safety, SOP, discipline practices and terminologyDemonstrate laboratory engineering troubleshooting using hand tools and test measurement equipment such as digital volt meters, flow meters, temperature indicators.Perform back-ups of the laboratory instruments and systems as neededPerform instrument calibrationsIdentify and implement improvements to laboratory engineering operationsWork under supervision on complex projects and may assist less experienced peersExecute self-directed laboratory engineering projectsManage small complex laboratory engineering projectsAbility to supervise the activities of contractor(s) as requiredOther duties as assigned
BACKGROUND REQUIREMENTS:
Education/Experience:BSc./Chem. Eng. degree or equivalent; or 3+ to 5+ years related experience and/or training; or equivalent combination of education and experience.GMP Experience:Laboratory Engineer II is a mid-level position in the Laboratory Engineering department of FDBU, requiring three years of GMP experience.Basic knowledge of FDA regulation 21 CFR Part 11Knowledge of Data Integrity on FDA regulated environments.On-Call:The Laboratory Engineering department provides 24 hour support for manufacturing and laboratories.This position will be required to support off-hours requests.The Major Equipment and Systems that are supported include, but not limited to:Ultra Performance Liquid Chromatography (UPLC)High Performance (Pressure) Liquid Chromatography (HPLC)Liquid Chromatography/Mass SpectrometryUltraviolet–Visible SpectroscopyPlate ReaderDensitometryCell CountingChromatography Data SystemsExperience using laboratory equipment such as pipettes, balances, pH meters.Qualifications:Proficient computer skills with experience using MS Office softwareExcellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to managementExcellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levelsSelf-starter and detail orientedAbility to manage commitments while displaying an eagerness to learn and continuously improveExcellent presentation skills with the ability to clearly articulate sound reasoning and data when recommending courses of actionAbility to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-automation personnelAbility to work in a cross functional team environmentFDBU 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.
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