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Process Engineer
4 weeks ago
Job Description:
We are seeking a Process Development Associate to join our team at Thousand Oaks. The ideal candidate will be a flexible commuter, able to be onsite as needed based on business needs, and should expect to be onsite weekly. This role involves supporting senior staff in developing and characterizing drug product technologies and manufacturing capabilities, assisting in process validation, and facilitating technology transfer of multiple products to aseptic fill finish manufacturing plants.
Responsibilities:
- Support senior staff in the planning, execution, and documentation of characterization, process validation, and technology transfer projects.
- Execute characterization studies and experiments at both lab and production scales, using complex technology to generate technical data packages.
- Liaise with various drug product teams to ensure successful technology transfer, with associated documentation.
- Assist in establishing experimental design, developing and executing protocols, obtaining reproducible and reliable results, analyzing and documenting experimental results, and communicating results to cross-functional groups.
- Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials.
- Assist in the design and execution of experiments to characterize and enable the implementation of new capabilities and process changes such as filling, lyophilization, and analytical technologies.
- Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments.
- Support development and maintenance of technology transfer tools (clinical and commercial).
- Effectively communicate results of characterization studies, experimental execution, and technology transfer initiatives.
- Author/review/verify technical documents, such as technical protocols, technical assessments, technical reports, and draft standard operating procedures or guideline documents.
- Conduct data analysis, including statistical analysis using Minitab, JMP, etc.
- Develop digital tools and models by leveraging data analytics and programming skills.
- Support at-scale characterization and/or process validation runs as a person in plant.
Preferred Qualifications:
- B.S. in an engineering discipline with 1‒3 years of experience or M.S. in an engineering discipline with 0‒2 years of experience.
- Familiarity with cGMP and experience in drug product/drug substance manufacturing or process development.
- Knowledge of and hands-on experience with various drug product technologies.
- Strong critical thinking, problem-solving, and independent research skills.
- Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies.
- Excellent project management skills and ability to escalate relevant issues to project lead and line management.
- Strong cross-functional team player with good communication skills (oral and written).
- Ability to work independently and as part of a team with internal and external partners.
- Good computer and organizational skills with strong attention to detail.
- Self-motivated with a positive attitude.
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