Quality & Validation Engineer

Associate PLM Quality & Validation Engineer

Let's do this. Let's change the world. In this vital role you will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant.

• 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

• Contribute actively to release planning and estimate test efforts

• Test in an Agile development environment, analyze and communicate test results to team and manager

• Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), Validation Reports, RTM, deviations, change control, and non-conformance management.

• Assist with UAT, test data preparation and developing work instructions.

• 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, product owners, business owners to execute validation activities and meet project deadlines.

• Work closely with manager to ensure timely and effective completion of all validation activities in line with project objectives and schedules.

• Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies.

• Collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution.

Basic Qualifications:

• Bachelor's degree and 3 to 5 years experience in Software Quality and GMP Validation

Preferred Qualifications:

Must-Have Skills:

• Experience in Quality Assurance (QA) testing with at least 3 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions.

• Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.).

• Overall experience in developing, executing and analyzing QA & Test Automation

• Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation.

• Experience with computer system validation and software validation.

• Strong problem-solving and analytical skills.

• Understanding of 3DExperience platform architecture, modules, and integration points is highly desirable

• Experience with automated and computer-controlled systems validation (21 CFR Part 11)

• 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.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with 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 an accommodation.