Senior Engineer

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Engineer

What you will do and what we expect of you

Let’s do this. Let’s change the world. In this vital role you will:  

Duties: Lead or support new product introductions and lifecycle changes into Amgen Thousand Oaks drug product manufacturing facility as the Process Development lead by integrating products' process design and requirements with the site's procedures and capabilities; Collaborate with multiple plant functions to ensure the aseptic fill finish equipment and procedures that constitute the DP platform processes are fully characterized to enable efficient and successful tech transfers of Amgen's clinical & commercial product portfolio; Act as point contact to provide knowledge of clinical and commercial manufacturing site process capabilities and practices; Support make-a-batch exercises to determine facility fit and identify gaps; Design, implement and document off-line and on-site DP characterization studies; Design, plan, and provide floor support to engineering, machinability, and process performance qualifications (PPQ) runs required to ensure successful product commercialization; Author and own high-quality process technology transfer and other technical documents; Development of validation plans and supports execution of PPQs for commercial manufacturing; Authors and reviews process validation protocols, assessments and reports within Amgen's quality systems; and Supporting regulatory filings and health authority interactions as an SME including writing responses and participating in regulatory audits. Supervises direct reports. May telecommute. 

Requirements: Master’s degree (or foreign degree) in Chemical Engineering, Biotechnology, or related field & 2 years in the job offered or in an engineering related occupation. Position requires 2 years experience in the following: 

1. Transferring drug product processes of parenteral drug products including biologics or vaccines to fill or finish GMP Manufacturing for clinical and commercial use, integrating and monitoring developed processes to plant procedures and equipment capabilities post transfer and lead Life Cycle Management (LCM) initiatives;  

2. Designing, planning, executing, or documenting in silico, off-line, or on-line characterization studies and integrating established process operating ranges in recipes or batch records; 

3.   Improving manufacturing performance by establishing monitoring programs, routinely checking for trends, or identifying process improvements and exploring new technologies;  

4. Implementing Corrective and Preventive Actions (CAPAs) and change controls using Trackwise, Integrated Document Management (IDM) or Organizational Change Management (OCM) systems; 

5.  Investigating process deviations to identify root causes and causal factors using tools including: Level 0, Fishbone analysis, or contradiction matrix;  

6. Designing and supporting studies that are used in regulatory filings that meet the applicable regulations from FDA, EU, or global standards and conduct internal audits to prepare plant for pre-approval inspections (PAI); and  

7. Technical knowledge and knowledge of validation for regulatory filings, audits, or inspections. 

Contact: Interested candidates please apply via https://careers.amgen.com/en/search-jobs and search for job # R-239022. 

Job type: Full Time position. The annual salary range for this position in the U.S. is $