Process Engineer
$38 - $40 per hourACL Digital
Direct message the job poster from ACL Digital Senior Talent Acquisition Specialist | Client Services | Driving Talent Solutions @ACL Digital Duration: 12+Months Location: Thousand Oaks CA 91320 Description: Ideal Candidate: B.S. + minimum of 1+ years of experience. (non educational experience) Nice to Have Skills: New product introduction, tech transfer, previous biotech / pharma experience. Chemical or biomedical engineering degree. 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 in order 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 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/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
- 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
- Support at scale characterization and/or process validation runs as person in plant
- B.S. in engineering discipline with 1‒3 years’ experience or M.S. in engineering 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 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
- 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 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
- 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 in order 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 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/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
- 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
- Support at scale characterization and/or process validation runs as person in plant
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