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Process Development Engineer
Job
ACL Digital
Thousand Oaks, CA (In Person)
Full-Time
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Job Description
Process Development Engineer at ACL Digital Process Development Engineer at ACL Digital in Newbury Park, California Posted in about 4 hours ago.
Type:
full-timeJob Description:
Job Title:
Process Engineer/Tech Transfer Location:
Thousand Oaks CA Duration:
1 years contractDescription:
Top 3Must Have Skill Sets:
1. Strong cross functional team player with good communication skills (oral and written). 2. Good computer and organizational skills with strong attention to detail. 3. 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