Process EngineerACL Digital • Thousand Oaks, CA, US
Process Engineer
ACL Digital • Thousand Oaks, CA, US
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job_description.job_card.job_descriptionB.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
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
Preferred Qualifications :
Basic Qualifications
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Max Rate Not to Exceed (If this differs from the job posting template) :
(No Value)
Why is the Position Open?
Supplement to the teams workload.
Top 3 Must Have Skill Sets :
Day to Day Responsibilities :
Responsibilities include, but are not limited to, the following :
Seniority level
Seniority level
Associate
Employment type
Employment type
Contract
Job function
Job function
Product Management, Engineering, and Manufacturing
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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