Specialist IS Engineer (Remote)
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 IS Engineer
What you will do
Let’s do this. Let’s 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
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.
Master’s degree and 3 years of Information Systems/System engineering experience
Bachelor’s degree and 5 years of Information Systems/System engineering experience
Associate’s degree and 10 years of Information Systems/System engineering experience
High school diploma / GED and 12 years of Information Systems/System engineering experience
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.
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
for a career that defies imagination
Objects in your future are closer than they appear. 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.
Something looks off?