Amgen Principal Validation Engineer in Thousand Oaks, California
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
What you will do
Let’s do this! Let’s change the world!
Oversee process, cleaning, filter and sterilization/sanitization validation activities as CMOs.
Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
Translates Amgen requirements into the language of the CMO-can make a risk-based decision
Validation document author/approver
Regulatory - Aseptic processing system oversight (media fill, autoclave validation, EM) content authorship
Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
Prepare inspection playbooks
Validation change control assessment
Review / Approve Master Batch Records
Perform Person in Plant activities as required
Author applicable MA filing sections
Drive Operational Excellence and Champion Change
Determine outcome of validation activities
Decision to approve or reject validation documentation
Provide Validation position on related topics and strategy for the site
Decision to approve Master batch Records
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.
Basic Qualifications :
Doctorate degree & 2 years of directly related experience OR
Master’s degree & 4 years of directly related experience OR
Bachelor’s degree & 6 years of directly related experience OR
Associate’s degree & 10 years of directly related experience OR
High school diploma / GED & 12 years of directly related experience
Preferred Qualifications :
10 + years biotech or pharmaceutical industry experience
Additional European Languages - desirable not essential
Significant Validation experience at Aseptic Manufacturing facilities & or small molecules.
Able to facilitate and influence senior stakeholders and partners
Able to successfully manage workload and timelines
Familiarity with basic project management tools
Ability to negotiate a strategic position after taking feedback from multiple sources
Strong project management, problem-solving, and analytical skills
Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
Ability to operate in a matrixed or team environment with site, functional, and executive leadership
Experience driving decision making by using DAI principles
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.