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Principal Validation Engineer

Employer
Amgen
Location
New Albany, Ohio
Start date
May 29, 2024

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Discipline
Engineering, Validation Engineer
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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 controls
  • Overseen development of Validation Plan and Strategy
  • Manage C&Q/Characterization and Validation execution
  • Align Strategy and responses for internal audits on Packaging Equipments validation Protocol and Plans
  • Act as a Validation Lead for all validation projects
  • Coordinate business activities and assign business tasks to support executions
  • Evaluate proposed changes to validated systems and recommend level of validation required
  • Led all aspects of project management activities for validation projects process within the scope of an overall system project
  • Assist with the development of system requirements and specifications to ensure requirements are testable and met
  • Implement 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 experience
  • Validation experience on Pharmaceutical Packaging Process and Equipment Validation with focus on Combination Products
  • Able to facilitate and influence senior collaborators and partners
  • Able to successfully manage workload and timelines
  • 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 partners and drive issue resolution
  • Ability to operate in a matrixed 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, 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 plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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