System Owner
System Owner
US - Puerto Rico - Juncos Apply NowJoin Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
System Owner
What you will do
Let’s do this. Let’s change the world. In this vital role you will provide and own all the technical aspects in a manufacturing line. It is required to be familiar with processes such as: optimization strategies and/or troubleshooting of operational issues in the operations, packaging manufacturing processes, pilot technologies and/or capital projects. Changes to the work schedule may occasionally be requested in response to business requirements.
Support daily operations and resolve equipment or process issues to meet production goals
Organize, analyze, and present findings from operational or engineering investigations
Apply sophisticated and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or projects.
Interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams.
Act as technical expert for assigned systems or equipment
Define design requirements to the service providers to fulfill area technical and equipment needs.
Conduct product and process impact assessments for non-conformances, including defining CAPAs
Contribute to process optimization initiatives focused on cost, capacity, and robustness
Work with other business functions such as research, manufacturing, process development, utilities, facilities, quality assurance and validation departments to support complex systems and/or facilities modifications.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The System Owner professional we seek is an individual contributor with these qualifications.
Basic Qualifications:
Master’s degree
OR
Bachelor’s degree and 2 years of Engineering experience
Preferred Qualifications:
Experience in a GMP-regulated environment within pharmaceutical, biotech, or medical device industries
Maintenance knowledge and experience with automated and manual inspection equipment operation.
Familiarity with inspection equipment, process characterization, validation, monitoring, and optimization techniques
Technical knowledge of inspection technologies for parenteral and glass containers
Ability to apply engineering principles to solve technical problems in a production environment
Demonstrated problem-solving and applied engineering skills
Basic knowledge with validation and documentation processes in a highly regulated environment
Protocol Development and execution requirements.
Technical writing and verbal communication on English and Spanish
Good organization, presentation and change management skills
Availability to support non-standard shifts, including extended hours, nights, weekends, and holidays
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.
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:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
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 an annual site shutdown
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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Sponsorship
Sponsorship for this role is not guaranteed.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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.