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Posted:5 days ago| Platform: Foundit logo

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Job Description

In this vital role, you will support the implementation and operational management of real-world evidence platforms at Amgen, ensuring integrity and compliance of critical systems and data. The role requires close collaboration with developers, business analysts, and product managers to ensure detailed and quality technical delivery in an Agile environment. You will maintain efficient development workflows, ensure robust testing practices, and uphold compliance with GxP and regulatory standards . Key Responsibilities Develop detailed test plans and strategies based on project requirements Perform manual and automated testing , including functional, regression, and performance testing Document and report defects/issues and collaborate with development teams for resolution Maintain documentation of test/validation plans, test cases, and results Validate test scenarios against acceptance criteria and customer expectations Ensure user stories and requirements are well documented in Jira Provide technical validation support to meet quality, cost, and troubleshooting objectives Prepare, execute, document, and report validation protocols compliant with GxP and regulatory requirements Ensure validation procedures align with corporate and government regulations Perform IQ, OQ, and PQ validations for processes, equipment, and systems, including supplier coordination when needed What We Expect of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications Master's degree with 46 years of experience in Life Sciences, Biotechnology, Pharmacology, or Information Systems OR Bachelor's degree with 68 years of experience in the above fields OR Diploma with 1012 years of experience in the above fields Functional Skills Must-Have: Strong problem-solving skills for complex technology challenges in drug discovery Experience with Agile methodologies (Scrum) Strong communication skills with ability to present to senior leadership Experience with validation , compliance , and data integrity standards Good-to-Have: Familiarity with cloud platforms (AWS, Databricks) and GCP regulations Experience with validation solutions in life sciences Ability to communicate complex subjects in business-friendly terms Experience with Jira Align Professional Certifications (Preferred) SAFe for Teams certification Soft Skills Works well under minimal supervision Excellent analytical and troubleshooting abilities Strong verbal and written communication Effective collaboration in global, virtual teams Initiative and self-motivation Ability to manage multiple priorities successfully Strong team orientation and public speaking skills Shift Information This position requires late, second, or third shift schedules Must be willing and able to work evening or night shifts as per business requirements

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