Process Sciences Engineer I/II

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.

The Process Scientist/Engineer I represents the technical operations department before FDBU customers, regulatory agencies and management. This individual will manage the new client process and ensure project objectives are completed. The Process Scientist/Engineer will also contribute to the technology transfer of multiple projects at various project life-cycle stages (clinical material to commercial supply). Additionally, this individual must possess strong process understanding to implement and execute process risk review and process/cleaning qualification and validation activities.

Major Activities and Responsibilities

  • May support technical transfer of client project in and to manufacturing as applicable
  • Summarizes and report data
  • Interacts with supervisor and reports results and interpretation of experiments, project deliverables, and process readiness.
  • Supports capital projects by providing technical expertise
  • Supports new project site-fit assessments as needed
  • Assists in developing SOPs and engineering documents
  • Familiar with relevant literation
  • Consult with senior peers on non-complex projects to learn through experience
  • Demonstrate skill with moderate level of proficiency in administrative work
  • Acquire understanding of GMPs, safety, SOP, discipline practices and terminology
  • Acquire understanding of production troubleshooting
  • Learn and apply basic project management

Proficiencies

  •  Independent use and application of, computer systems and software for data acquisition and analysis
  • Capable of using basic computer systems and software to perform basic data analysis
  • Basic math and software skills (excel data plotting, proficient with MS Word for memos and updates)
  • Acquire understanding of GMPs, safety, SOP, discipline practices and terminology
  • Acquire understanding of basic production and production troubleshooting
  • Advanced technique and biology, chemistry or biochemistry knowledge
  • Independent use and application of complex instrumentation, computer systems and software for data acquisition and analysis
  • General knowledge of Excel, Word and PowerPoint.
  • Understanding of analytical or process experimental design
  • Demonstrates knowledge of instruments, computer technology, and data analysis required to successfully complete project work

Problem Solving

  • Demonstrates a practical understanding of own engineering discipline and applies knowledge in support of product development.
  • Understands and applies use of equipment, technology and materials associated with area of expertise and related studies and projects.
  • Works on multiple problems of higher complexity.
  • Implements new methods and processes.
  • Adequately assembles reports and presentations describing scientific information.
  • Familiarity with available new technologies and vendor offerings

Oral & Written Communication

  • Assist in developing SOPs and engineering documents
  • Prepares summaries of data for technical reports (memos, development reports)
  • Write and review qualification/validation/tech transfer protocols
  • Write and review qualification/validation/tech transfer reports or SME content of technical reports (memos, development reports etc)
  • May author reports for internal distribution.
  • Collaborates and communicates across work groups and project teams.
  • Communicates with customers with support from manager or technical lead.
  • Presents at departmental meetings to keep managers and team members apprised of the activities on project.

 Leader Behaviors

  • Takes responsibility for the consequences of his/her actions
  • Demonstrates willingness to share roles with others on the team to advance team’s progress as needed
  • Practices attentive and active listening
  • Reviews work to ensure accuracy, completeness, and quality
  • Looks for opportunities for improving work

 

Background Requirements

 Engineer I

  • degree or equivalent; or four to ten years related experience and/or training; or equivalent combination of education and experience
  • Independent use and application of, computer systems and software for data acquisition and analysis
  • Capable of using basic computer systems and software to perform basic data analysis
  • Basic math and software skills (excel data plotting, proficient with MS Word for memos and updates)
  • Acquire understanding of GMPs, safety, SOP, discipline practices and terminology
  • Able to acquire an understanding of basic production and production troubleshooting

Engineer II

  • degree or equivalent and 4+ years of experience, MS or equivalent
  • Advanced technique and biology, chemistry or biochemistry knowledge
  • Independent use and application of complex instrumentation, computer systems and software for data acquisition and analysis
  • General knowledge of Excel, Word and PowerPoint.
  • Understanding of analytical or process experimental design
  • Demonstrates knowledge of instruments, computer technology, and data analysis required to successfully complete project work.
  • Demonstrates a practical understanding of own engineering discipline and is able to apply knowledge in support of product development.

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.

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