Manufacturing Sciences and Technology Validation Manager

Profile

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! In this vital role you will lead validation deliverables on a team responsible for cleaning, sterilization/sanitization, utility, airflow visualization, and benchtop testing equipment validation activities at AR5 and AR30 production facilities. Responsibilities will include validation program management. Responsibilities could potentially include management of direct reports.

Key Responsibilities

• Be an integral member of ARI validation leadership

• Validation document author/approver

• Regulatory - validation oversight content authorship

• Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas

• Prepare inspection playbooks

• Validation change control assessment

• 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

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 OR
• Masters degree and 3 years of Manufacturing or Operations experience OR
• Bachelors degree and 5 years of Manufacturing or Operations experience OR
• Associates degree and 10 years of Manufacturing or Operations experience OR
• High school diploma / GED and 12 years of Manufacturing or Operations experience

Preferred Qualifications:

• 10 + years biotech or pharmaceutical industry experience

• Significant Validation experience at Drug Substance Manufacturing facilities

• 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

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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.

We will ensure that individuals with disabilities are provided 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 accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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