Specialist IS Engineer

Specialist IS Engineer In this vital role, you will evaluate Veeva features, determine their potential value, and present a demonstration to the Business Governance members. You will design, prototype, document, build, configure, test, and implement CDOCS (Controlled Docs A Veeva Vault Quality Document Management System) configurations to support business requirements and user stories. You will create and execute validation test scripts in the ALM tool, perform Installation Qualification and Qualification Testing protocols, and ensure the solution aligns with Amgen IS strategy, standards, and operating procedures to maintain system validity. You will lead and run all aspects of deviation and non-conformance incidents for CDOCS, manage root cause investigations, corrective and preventive actions (CAPA), effectiveness verifications, and documentation. Additionally, you will lead complex IS document migration projects into CDOCS, support analysis, design, test, implementation, and change‑management phases of ongoing projects, and plan and lead product improvement releases using Agile methodology (Scrum Master). May telecommute. Qualifications Masters degree (or foreign equivalent) in Computer Science, Information Technology, or related field and 3 years of experience involving the following: Performing and maintaining computerized system validation per FDA 21 CFR Part 11 guidance for GXP systems, including identifying and implementing continuous improvement opportunities related to compliance practices and issues based on internal compliance. Experience in the biotech industry and working with GxP computer systems in a regulated environment. Working with business clients to understand processes, lead scope of work, set expectations, and recommend solutions. IS change‑control process and building, validating, and supporting GxP systems. Planning, executing, and documenting validation activities in compliance with Computer System Validation (CSV). Defining an automation testing strategy with an in‑house automation framework. Conducting user acceptance testing sessions and ensuring the system is built per business needs. Compensation and Benefits Full‑time position. Annual salary range: $138,674.00 – $144,146.00 per year. In addition to base salary, this role offers stock, retirement, medical, life and disability insurance, and eligibility for an annual bonus. Other benefits include health and welfare plans, financial plans, work/life balance and career development opportunities. Benefits include: Retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Discretionary annual bonus program, or sales‑based incentive plan for field sales representatives. Stock‑based long‑term incentives. Time‑off plans. Flexible work models, including remote and hybrid arrangements, where possible. Equal Opportunity Employer 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, disability status, or any other basis protected by applicable law. 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. Additional Information Amgen does not have an application deadline for this position; applications will remain open until the position is filled. #J-18808-Ljbffr Initial Therapeutics, Inc.