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 / Masters degree / Bachelors degree and 8 to 13 years of Software Quality and GMP Validation .

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.

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Sr PLM Software Quality & Validation Engineer