Principal Validation Engineer

4 weeks ago

New Albany, United States Amgen Full time

Principal Validation Engineer page is loaded

Principal Validation Engineer

Apply

remote type

On Site

locations

US - Ohio - New Albany

time type

Full time

posted on

Posted 2 Days Ago

job requisition id

R-182768

Career Category

Engineering

Job Description

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. Principal Validation Engineer Live

What you will do Let’s do this. Let’s 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/CAPA’s 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 Equipment’s 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 Master’s Engineer or Science degree & 4 years of directly related experience OR Bachelor’s Engineer or Science degree & 6 years of directly related experience Or Associate’s 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. .

Salary Range 143,568.00 USD - 166,488.00 USD About Us

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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