Sr Validation Engineer

Job Description

What you will do Lets do this. Lets change the world. In this vital role you will support the implementation and operational management of real-world evidence platforms at Amgen, ensuring the integrity and compliance of critical systems and data. This role involves collaboration with various Amgen teams to enhance and secure real-world evidence operations. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality results from the team. Roles & Responsibilities: Develop detailed test plans and strategies based on project requirements and specifications. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects and issues identified during testing, and work with development teams to resolve them. Maintain detailed documentation of test/validation plans, test cases, and test results. Validate that test scenarios meet feature acceptance criteria and customer expectations. Maintain and ensure the quality of documented user stories/requirements in tools such as Jira. Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment. Prepare, execute, document, and report validation protocols in line with GxPs and other regulatory requirements and standards. Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations. Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Masters degree with 4 - 6 years of experience in Life Science/ Biotechnology/ Pharmacology/ Information Systems experience OR Bachelors degree with 6 - 8 years of experience in Life Science/ Biotechnology/ Pharmacology/ Information Systems experience OR Diploma with 10 - 12 years of experience in Life Science/ Biotechnology/ Pharmacology/ Information Systems experience Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience with validation solutions, including compliance and data integrity. Good-to-Have Skills: Familiarity with cloud platforms (AWS / Databricks) and GCP regulations. Experience with validation solutions, including compliance and data integrity. Able to communicate technical or complex subject matters in business terms Jira Align experience Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision. Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams, High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.