Job Description

Title: Engineer

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:

• 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

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:

• 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

Day to Day Responsibilities:

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

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