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.

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

• 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, 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.

What we expect of you

We 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:

• Bachelor’s degree and 2 to 6 years experience in Software Quality and GMP Validation

Preferred Qualifications:

Functional Skills:

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.

Good-to-Have 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)

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.

and make a lasting impact with the Amgen team.

careers.amgen.com