Principal Validation Engineer

3 weeks ago

New Albany, United States Amgen Full time

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.

Principal Validation Engineer

Live

What you will do

Lets do this. Lets change the world. In this role you will lead and coordinate Packaging Process Validation, Packaging Equipment C&Q/Characterization, Packaging Components Qualifications, Commercial Support, Process Monitoring, Deviations/CAPAs and Lab Operation for Combination Products.

Key Responsibilities

Ensure initiation/preparation and closeout of all validation related documents and change controlsOverseen development of Validation Plan and StrategyManage C&Q/Characterization and Validation executionAlign Strategy and responses for internal audits on Packaging Equipments validation Protocol and PlansAct as a Validation Lead for all validation projectsCoordinate business activities and assign business tasks to support executionsEvaluate proposed changes to validated systems and recommend level of validation requiredLed all aspects of project management activities for validation projects process within the scope of an overall system projectAssist with the development of system requirements and specifications to ensure requirements are testable and metImplement or coordinate the execution of validation plans and validation documents;Coach the implementation teams in the proper execution of validation documents;Preapprove test scripts before they are executed and approve after they have been executed.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate Engineer or Science degree & 2 years of directly related experience

OR

Masters Engineer or Science degree & 4 years of directly related experience

OR

Bachelors Engineer or Science degree & 6 years of directly related experience

Or

Associates degree and 10 years of directly related experience

Or

High school diploma / GED and 12 years of directly related experience

Preferred Qualifications:

6 + years biotech or pharmaceutical industry experienceValidation experience on Pharmaceutical Packaging Process and Equipment Validation with focus on Combination ProductsAble to facilitate and influence senior collaborators and partnersAble to successfully manage workload and timelinesAbility to negotiate a strategic position after taking feedback from multiple sourcesStrong project management, problem-solving, and analytical skillsCollaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolutionAbility to operate in a matrixed environment with site, functional, and executive leadershipExperience 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, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.com

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 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.

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