Description
**HOW MIGHT YOU DEFY IMAGINATION?**
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
**Specialist Computer Validation System Engineer, Amgen Ohio (AOH)**
**Live**
**What you will do**
Let’s do this. Let’s change the world. In this vital role you will serve as a technical lead/SME and own the development and implementation of the Computer/Information Systems validation strategy at the Amgen Ohio (AOH) manufacturing facility. Specifically, this role has responsibility for handling the portfolio of computer systems validation deliverables, developing and generating documents such as the site’s Computer/Information Systems Validation Master Plan, validation plans, system qualification protocols/reports, among others.
+ Provide technical support and domain expertise for commissioning, qualification, and validation maintenance activities in AOH
+ Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing digital systems
+ Coordinate actions with Manufacturing, Engineering, Quality, and Supply Chain business to ensure that the overall Amgen validation requirements are met
+ Support inspection readiness activities
+ Furnish technical assistance and represent validation for regulatory filings, audits, and inspections
+ Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of systems
+ Support site/network validation driven continuous improvement initiatives
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The validation professional we seek is a will have these qualifications.
**Basic Qualifications:**
**Doctorate degree**
OR
Master’s degree and 3 years of Validation or Engineering or Information Systems experience
**Or**
Bachelor’s degree and 5 years of Validation or Engineering or Information Systems experience
**Or**
Associate’s degree and 10 years of Validation or Engineering or Information Systems experience
**Or**
High school diploma/GED and 12 years of Validation or Engineering or Information Systems experience
**Preferred Qualifications:**
+ Proficient technical writing and presentations skills so as to collaborate with technical and senior management staff
+ Expertise in information systems qualification for manufacturing facility
+ Extensive experience in reviewing/approving validation protocols and reports in support of facility/information systems commissioning, qualification, and change administration
+ Involvement in technical implementation of validation tasks associated with core and sophisticated information digital systems
+ Experience with SAFe and traditional Agile methodology coupled with strong GxP experience
+ Knowledge of Regulations FDA Title 21 CFR Part 210 and 211
+ Participation in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans
**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.
The annual base salary range for this opportunity in the U.S. is provided below.
**$107,134-$129,381 usd**
In addition to the base salary, 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**
**#NBMBAA**
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 cancers, 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.
