Engineer

Thousand Oaks, CA 91320 US

Posted: 11/18/2025 2025-11-18 2025-12-19 Employment Type: Contract Job Category: Engineering Job Number: 623984 Is job remote?: Hybrid Country: United States

Job Description

As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.

Key responsibilities include:

• Supports the establishment of robust tactical and strategic objectives related to visual inspection
• Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect panels, establishment of GMP procedures related to operations)
• Implements and documents off-line and on-site drug product characterization studies
• Author and/or own high-quality process technology transfer and other technical documents
• Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
• Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
• Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations
• Support one or more clinical and commercial process introductions or process transfers into Amgen manufacturing network

Preferred Qualifications

• 2+ years of experience within the pharmaceutical/biotechnology industry
• Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters
• Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
• Ability to learn and act on dynamic information at a rapid pace
• Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
• Strong knowledge of quality systems and drug product manufacturing
• Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
• Capable of organizing and communicating complex technical concepts to enable business decisions

Pay ranges between 33-39/hr based one xperience

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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