Sr Plm Software Quality

Career Category Quality Let s do this Let s change the world In this vital role you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes documentation and comply with Amgen s 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 and Beta Develop and maintain comprehensive test plans for 3DExperience platform modules and application Lead mentor and coach junior Quality and Validation engineers in their activities Analyze test results collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution Develop validation documentation such as Validation Plans Validation Protocols IQ OQ Validation Reports deviations change control non-conformance and other Computer System Validation CSV documents Ensure validation strategies meet regulatory requirements and company standards Guide junior validation engineers in writing the CSV documents and verify their output for completeness accuracy and quality Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards Lead test automation scripting framework maintenance and CI CD integration Develop and execute automated test suites across various modules in 3DEXPERIENCE 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 Ensure timely and effective completion of all validation activities in line with project objectives and schedules Involve actively in release planning and estimate test efforts Identify opportunities for process improvements in validation activities Stay current on new technologies validation trends and industry best practices to improve validation efficiencies Basic Qualifications Doctorate degree Master s degree Bachelor s degree and 8 to 13 years of Software Quality and GMP Validation Preferred Qualifications Functional Skills Must-Have Skills Experience in Quality Assurance QA testing with at least 6 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM enterprise software solutions Strong experience in manual and automated testing for complex applications especially in the 3DEXPERIENCE platform Experience in Computerized System Validation in a GMP-regulated environment pharmaceutical biotech medical devices etc Experience in QA Test Automation is expected Experience leading software validation projects Proficiency in developing and executing validation protocols IQ OQ PQ reports and related documentation Hands-on experience executing and analyzing automated test suites Familiarity with computer system validation and software validation is a plus Strong problem-solving and analytical skills Good-to-Have Skills Understanding of 3DExperience platform architecture modules and integration points Experience with automated and computer-controlled systems validation 21 CFR Part 11 Soft Skills 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 Ability to learn quickly be organized and detail oriented Strong presentation and public speaking skills What you can expect of us As 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 we ll 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 com