3 Days Left: Validation Engineer I

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 IWhat you will doLets do this Lets change the world In this vital role you will be a skilled Software Test engineer to develop implement and maintain the test scripts for data platforms and custom-built solutions This is a hands-on growth-oriented position ideal for someone looking to deepen their skills in Front-end testing Back-end testing API testing and test automation As a key contributor you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes documentation and align with Amgens standard operating procedures policies and guidelines Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant Roles Responsibilities The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional System Stress Performance Integration Regression Database and Beta Actively involved in release planning and estimate test effortsCollaborate and test in an Agile development environmentAnalyze and communicate test results to team and managerDevelop validation documentation such as Validation Plans Validation Protocols IQ OQ and Validation Reports Ensure validation strategies meet regulatory requirements and company standards Write Installation Qualification IQ Operational Qualification OQ and Computer System Validation documents Stay updated on relevant changes to Amgens SOPs and ensure validation practices are aligned with evolving standards Contribute to test automation scripting framework maintenance and CI CD integration Implement automated test suites across various layers including data pipelines APIs and semantic layers Analyze test automation results identify failures or inconsistencies and assist in root cause analysis Collaborate with cross-functional teams including quality assurance system owners business owners RunOps engineering and platform teams to drive validation activities and meet project deadlines Work closely with manager on implementing automation strategies document all bugs in a tracking tool and always follow the best QA practicesEnsure timely and effective completion of all validation activities in line with project objectives and schedules Ensure proper documentation of validation activities including deviations change control and non-conformance management Identify opportunities for process improvements in validation activities Stay ahead of on new technologies validation trends and industry best practices to improve validation efficiencies Collaborate and communicate effectively with the product teams What we expect of youWe are all different yet we all use our unique contributions to serve patients The vital attribute professional we seek is a type of person with these qualifications Basic Qualifications Masters degree and 1 to 3 years of Computer Science IT or related field experienceOrBachelors degree and 3 to 5 years of Computer Science IT or related field experiencePreferred Qualifications Must-Have Skills 3 years of experience in validation in a GMP-regulated environment pharmaceutical biotech medical devices etc 6-8 Years overall experience in Testing Validation Projects2 to 4 years overall experience in QA Test Automation is expected Experience leading software validation projects Proficiency in developing and implementing validation protocols IQ OQ PQ reports and related documentation Hands-on experience implementing and analyzing automated test suitesFamiliarity with computer system validation and software validation is a plus Strong problem-solving and analytical skills Excellent communication and collaboration skills Good-to-Have Skills Experience with automated and computer-controlled systems validation 21 CFR Part 11 Soft Skills Excellent analytical and troubleshooting skills Strong verbal and written communication skillsAbility to work effectively with global virtual teamsHigh degree of initiative and self-motivation Ability to balance multiple priorities successfully Team-oriented with a focus on achieving team goals Ability to learn quickly be organized and detail oriented 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