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
Are you looking for a Class A CDL driving position that values your family... ...call at (***) ***-****!We are a trucking company in search of a professional local driver to run relay routes and drop &... ...and surrounding areas.This is a home daily position with day cab and is no-...
...Replies within 24 hours Benefits Competitive salary Health insurance Opportunity for advancement Company: Judiet Dere... ...Type: Full-Time Job Title: Insurance Account Representative - State Farm Agent Team Member Job Description: Judiet Dere Insurance...
We are looking for a Music Teacher for a school based in Beijing. This is a full-time position starting in August 2025. About the... ...offers a rich cultural and academic environment with a diverse international faculty. The school features extensive facilities, including modern...
...Job Description PrecisionERP is seeking a bilingual (French and English) IT Scrum Master for a 7 month contract at our client located in Montreal. Work will be 2-3 days onsite. Requirements: Facilitating Scrum events such as sprint planning, daily stand-ups...
...Job Description Why work for the Federal Bureau of Prisons? To protect society and positively change the lives of those in our care. You have a vital role in that mission. You are valued and trained to be prepared. You are rewarded beyond benefits with careers that...