Amgen

Principal Validation Engineer

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jul 21, 2021
Ref
R-123082
Required Education
High School or equivalent
Position Type
Contract

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Live

What you will do

Lets do this! Lets change the world!

Description

Oversee process, cleaning, filter and sterilization/sanitization validation activities as CMOs.

Key Responsibilities
  • 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

  • Write/review RTQs

  • Author applicable MA filing sections

  • Drive Operational Excellence and Champion Change

Authority
  • 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

Win

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

  • Masters degree & 4 years of directly related experience OR

  • Bachelors degree & 6 years of directly related experience OR

  • Associates 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

Thrive

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.

careers.amgen.com

#Operations21Equal 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.


Join Us

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.