Specialist IS Engineer

Company: Amgen Inc. (IR)
Location: Thousand Oaks
Posted on: September 16, 2023

Job Description:

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.LiveWhat you will doLet'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 StoriesCraft and execute validation test scripts; Installation Qualification and Qualification Testing protocolsWriting SDLC documentationPlan 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 decisionsEnsure solution alignment with Amgen IS strategy, standards, and operating procedures to maintain solution in a validated state.Develop business domain knowledgeLead 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 membersWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will have these qualifications.Basic Qualifications:ORMaster's degree and 3 years of Information Systems/System engineering experienceOrBachelor's degree and 5 years of Information Systems/System engineering experienceOrAssociate's degree and 10 years of Information Systems/System engineering experienceOrHigh school diploma / GED and 12 years of Information Systems/System engineering experiencePreferred Qualifications:BS/MS degree in Information Systems, Computer Science, Engineering or the Life Sciences2+ years experience in the biotech/pharmaceutical industry and working with GxP computer systems in a regulated environmentStrong 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 managementExperience 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 usAs 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 USDIn 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join 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.

Keywords: Amgen Inc. (IR), Thousand Oaks , Specialist IS Engineer, Engineering , Thousand Oaks, California