ENGINEER

Engineer

Location: Thousand Oaks, CA

Category: Engineering

Salary: Apply for details

Country: United States

Employment: Contract

Worksite: On-Site

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Job Description

As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple Amgen products to internal Amgen manufacturing sites. The candidate will be responsible for executing characterization studies and other experiments at the lab-scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of Amgen products. The candidate will assist in study design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross-functional groups. The candidate will also be responsible for developing and maintaining trackers for project status and other key outputs for the team.

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 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 transfer documents, and change control assessments.
• Support development of technology transfer tools (clinical and commercial) and automation of routine activities.
• 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
• 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, and AI
  
  

Preferred Qualifications

• B.S. in engineering or biotechnology discipline with 13 years experience or M.S. in engineering or biotechnology discipline with 02 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 elevate 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
  
  

Pay Rate Range: $30 – $44/hr depending on experience

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.