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
...ensuring quality across all deliverables. As a vital link between our creative teams and clients, you will manage both the big picture and the... ...the hourly equivalent for part time. WHAT YOU'LL DO Agency Team and Communication Management: ~ Serve as the strategic...
...Company outings and happy hours ~ Opportunity for growth ~ Annual company trip for Diamond Club, weve gone to Las Vegas, the Bahamas, Miami, Mexico, Cayman Islands, and this year Cancun! Does this sound like you? Apply today and take the first step toward a...
...Director of Finance and Accounting Job Description: Responsible for overseeing and maintaining all financial and accounting functions of the company, including budgeting, forecasting, cost control, month-end closings, financial statement preparation, payroll,annual...
Morningside University is now accepting applications for the full-time position of Admissions Counselor to join our hardworking, dynamic, and supportive team. This position will afford you the opportunity to make a difference in the lives of others while building a robust...
...markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the... ...world. About the Role The Pharmacovigilance Associate supports the companys safety and pharmacovigilance responsibilities by processing...