Process Scientist/Engineer II
Research Triangle Park, North Carolina
The Process Scientist/Engineer II 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.
The ideal candidate will be a validation engineer (focused on process validation, not equipment validation), have experience in process validation in biologics (cell culture/fermentation/purification), execution and documentation of process risk assessment (FMEA), assessment between equipment capability and process parameters (sometimes referred as control strategy assessment), PV protocol author, execution, and summary report, experience working through deviations (incident events), perform root cause analysis, and implementation of corrective actions and E&L (extractable and leachable) assessment per BPOG model (no experience required as we will use internal SOP).
Provide on-floor technical validation support (we are a 24/7 facility)
Provide sampling support (no experience required, but PPQ support team will be trained to perform sampling of product and/or buffers)
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 literature
- 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
- Work under close to moderate supervision with limited latitude for independent judgment
- Demonstrates a practical understanding of own engineering discipline and applies knowledge in support of product development and technical transfer.
- Provides solutions to a variety of problems of moderate scope and complexity.
- Consult with senior peers on non-complex process engineering projects to learn through experience
Oral & Written Communication Skills
- Maintains accurate records of ongoing projects in adherence with documentation standards.
- May prepare summaries of data for technical reports (memos, development reports)
- Writes SOPs and other cGMP documents
- Collaborates and communicates within and across the work group as needed.
- May present at departmental meetings to keep managers and team members apprised of the activities on project.
- Communication across work teams
- 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
- Receptive to direction from colleagues
- BS degree or equivalent and 4+ years of experience, or 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.