We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
We are seeking an IT Senior Engineer, specializing in Applications. The IT Department provides 24-hour support for manufacturing and laboratories. The IT Senior Engineer will be expected to attend all internal hands-on training for the SOP’s in the curriculum assigned to the position. The ideal candidate is able to work in a cross-functional team environment.
- Optimize system configurations to maximize performance and ensure availability
- Participate in planning and implementation of system changes and upgrades
- Perform periodic maintenance and systems review, including security roles, performance, and data integrity
- Maintain close collaboration with Quality departments, including business system owners
- Develop and maintain system documentation
- Support internal and third party inspections and audits (FDA, EMA, Clients, etc.)
- Troubleshoot and resolve questions/problems with assigned applications
- Resolves and/or coordinates the resolution of technical issues with assigned applications
- Create documentation for assigned applications and internal processes (SOPs)
- All other duties as assigned
- BS Degree in Information Technology, Chemistry, or Engineering with a knowledge laboratory or quality control/assurance operations.
- 3+ years of work experience in a cGMP/highly regulated environment, including understanding of Change Control, Computer Systems Validation, 21CFR/Part 11 compliance.
- Strong technical documentation skills
- Broad knowledge of laboratory and quality processes.
- IT Administration experience with any/all of the following Quality Systems:
- LabWare LIMS, including experience with the horizontal integration of LabWare to other enterprise systems and integration of pharmaceutical analyzers
- Waters Empower CDS
- Waters NuGenesis
- Knowledge / experience with Citrix as necessary to support LabWare and Empower
- Oracle Database administration experience preferred
- Proficiency writing Oracle / Microsoft SQL Queries
- Proficiency creating custom reports using Crystal Reports or similar documentation tools
- Knowledge of the Software Development Life Cycle (SDLC) for regulated life sciences industries.
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.