Validation Engineer 1 – Vault Quality

Career Category Information SystemsJoin Amgens Mission of Serving PatientsAt Amgen if you feel like youre part of something bigger its because you are Our shared missionxe2x80x94to serve patients living with serious illnessesxe2x80x94drives all that we do Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives Our award-winning culture is collaborative innovative and science based If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team Join us and transform the lives of patients while transforming your career Validation Engineer 1 Vault QualityWhat you will doWe are seeking an experienced Validation Engineer to work on Amgen Veeva Vault Quality and its hosted applications This role will be pivotal in ensuring compliance efficiency and innovation in the management of data validation processes The successful candidate will work on a small team and support continuous improvements and automation within the program This position combines technical expertise validation experience and a strong understanding of regulatory requirements The role also uses domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated Roles Responsibilities Develop comprehensive test plans and strategies based on project specifications and requirements Perform manual and automated testing of software applications including functional regression and performance testing Document and report defects identified during testing and collaborate with development teams for resolution Maintain detailed records of test plans test cases and test results to ensure traceability and compliance Validate test scenarios against feature acceptance criteria and customer expectations Ensure system compliance with regulatory requirements for data integrity traceability and reliability Find opportunities to enhance testing efficiency and minimize manual efforts Evaluate and adopt tools and technologies to improve automation capabilities Keep validation documentation updated and aligned with GxP standards Ensure strict alignment to change management processes for validated systems Stay informed on industry trends emerging technologies and regulatory updates relevant to GxP Provide expert technical support in validation to optimize quality efficiency and cost for developing solving and improving new and existing applications and platforms Responsibility 6 What we expect of youWe are all different yet we all use our unique contributions to serve patients Basic Qualifications Masters degree and 1 to 3 years of Life Science Biotechnology Pharmacology Information Systems experience OR Bachelors degree and 3 to 5 years of Life Science Biotechnology Pharmacology Information Systems experience OR Diploma and 7 to 9 years of Life Science Biotechnology Pharmacology Information Systems experience Functional Skills Must-Have Skills Experienced in GxP validation process Have 4-5 years of experience in the Pharmaceutical Manufacturing Industry 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 work with senior leadership with confidence and clarity Experience in writing requirements for the development of a modern web application Strong understanding of GAMP 5 guidelines 21 CFR Part 11 and Annex 11 Proficiency in automation tools data systems and validation software Preferred Qualifications Experience in Veeva Vault Quality and it related business processes Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific software systems strategy governance and infrastructure Familiarity with low-code no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Knowledge of DevOps Continuous Integration and Continuous Delivery methodology Professional Certifications Veeva Vault Platform Administrator preferred SAFe for Teams certification preferred Soft Skills Able to work under minimal supervision Skilled in providing oversight and mentoring team members Demonstrated ability in effectively delegating work Excellent analytical and gap fit assessment 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 What you can expect of usAs we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being From our competitive benefits to our collaborative culture well support your journey every step of the way In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards Apply now and make a lasting impact with the Amgen team careers amgen comAs 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 and live the Amgen values to continue advancing science to serve patients Together we compete in the fight against serious disease 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