About the role
Job Title: Process Engineer/Tech Transfer
Location: Thousand Oaks CA
Duration: 1 years contract
Description:
Top 3 Must Have Skill Sets:
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Strong cross functional team player with good communication skills (oral and written).
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Good computer and organizational skills with strong attention to detail.
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Strong technical/engineering background with critical thinking, problem solving and independent research skills. Team player and self starter.
Responsibilities include, but are not limited to, the following:
• 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 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 transfer documents, and change control assessments.
• Support development of technology transfer tools (clinical and commercial) and automation of routine activities.
• Effectively communicate results of characterization studies, experimental execution, and technology transfer initiatives.
• Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures
• Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
• Development of digital tools and models by leveraging data analytics and programming skills, and AI
Preferred Qualifications:
• B.S. in engineering or biotechnology discipline with 1‒3 years’ experience or M.S. in engineering or biotechnology discipline with 0‒2 years’ 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
• Displayed 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 elevate 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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