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Specialist IS Engineer (Remote)

Employer
Amgen
Location
Thousand Oaks, CA
Start date
May 17, 2023

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Specialist IS Engineer

Live

What you will do

Lets do this. Lets change the world. In this vital role you will partner with the Business Product Owner, Technical Product Owner, and other stakeholders to deliver business solutions. This individual will be an active participant in all phases of the Product Development Life Cycle (PDLC) and will require extensive hands-on technical work and experience working with and understanding of GxP computer system validation.

  • Elicit and refine business requirements for complex and multi-segmented business processes!

  • Design, prototype, document, build/configure, test, and implement CDOCS configurations to support business requirements/User Stories

  • Craft and execute validation test scripts; Installation Qualification and Qualification Testing protocols

  • Writing SDLC documentation

  • Plan and lead product improvement releases using Agile methodology (Scrum master)

  • Provide thought leadership and technical hands-on expertise to Amgen business stakeholders.

  • Facilitate complex design and technical discussions and influence decisions

  • Ensure solution alignment with Amgen IS strategy, standards, and operating procedures to maintain solution in a validated state.

  • Develop business domain knowledge

  • Lead and run all aspects of deviation/non-conformance incidents for CDOCS including performing the root cause investigation, identification of corrective and preventative actions (CAPA), performing effectiveness verifications (EV), and thoroughly documenting the findings and results.

  • Lead complex IS document migration projects into CDOCS (e.g. resulting from M&A activities)

  • Analyze new Veeva features, assess potential value, and demo to Business Governance members

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 have these qualifications.

Basic Qualifications:Doctorate degree

OR

Masters degree and 3 years of Information Systems/System engineering experience

Or

Bachelors degree and 5 years of Information Systems/System engineering experience

Or

Associates degree and 10 years of Information Systems/System engineering experience

Or

High school diploma / GED and 12 years of Information Systems/System engineering experience

Preferred Qualifications:
  • BS/MS degree in Information Systems, Computer Science, Engineering or the Life Sciences

  • 2+ years experience in the biotech/pharmaceutical industry and working with GxP computer systems in a regulated environment

  • Strong leadership/consultative, collaboration, project management, service delivery and process improvement skills to facilitate alignment across multiple stakeholder groups.

  • Strong experience in business analysis. Ability to work with business clients to understand their business processes, manage scope of work/expectations and suggest/recommend IS solutions.

  • Strong hands-on technical configuration experience with Veeva Vault QualityDocs. (Added plus if you are Vault Admin certified)

  • Experience or familiarity with the following technologies: Mulesoft, AWS (Added plus if you have experience with Application Programming Interface (API) integration and Structured Query Language (SQL).

  • Strong experience with Agile development methodologies (Sprint, Scrum, SAFe), working in Product teams, and DevOps. (Added plus if you are an experienced Scrum master.).

  • Experience leading the IS change control process and building, validating and supporting GxP systems.

  • Excellent written, presentation, and verbal communication skills and technical expertise to be able to communicate effectively with business and technology partners, including demonstrated experience presenting technology recommendations with a business perspective.

  • Self-motivated individual who can effectively collaborate across a matrix organization and with proven ability to quickly learn new concepts and technologies, and juggle multiple priorities.

  • Demonstrated ability of leadership, collaboration, project management

  • Experience in technical writing and performing sophisticated root cause analysis of incidents/deviations and handling CAPA.

  • Experience in leading complex migration projects of GxP documents into regulated systems.

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 $109,459-$132,557 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


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.

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

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