PLM Software Quality & Validation Engineer

Amgen Inc; Hyderabad; On-site; INR 1,116,000 - 1,674,000; Full time

Job summary

A global biotechnology firm is searching for a PLM Software Quality & Validation Engineer to develop and maintain test scripts for 3DEXPERIENCE platforms. This role involves validating compliance with standard operating procedures while also engaging in various testing methodologies. Candidates must have 6-8 years in Quality Assurance, including experience in GxP-regulated environments. The position offers an opportunity to work closely with cross-functional teams in an Agile setting, focused on ensuring software quality and regulatory compliance.

Qualifications

• 6-8 years in Quality Assurance testing with at least 3 years on the 3DEXPERIENCE platform.
• 3+ years in validation in a GxP-regulated environment.
• 2-4 years in developing, executing and analyzing QA & Test Automation.

Responsibilities

• Develop and maintain test plans for 3DExperience platform.
• Execute automated test suites across various modules in 3DEXPERIENCE.
• Collaborate with cross-functional teams for validation activities.

Skills

Quality Assurance Testing

Validation in GxP-regulated environment

Test Automation

Problem Solving

Analytical Skills

Education

Masters degree with 4-6 years experience or Bachelors degree with 6-8 years experience in Software Quality

Job description

• We seek a skilled PLM Software Quality & Validation Engineer to develop, execute and maintain the test scripts for 3DEXPERIENCE PLM platforms and custom-built solutions
• This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Functional testing and test automation on a cloud-based SaaS PLM software
• As a key contributor, you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and comply 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, and Beta.
• Develop and maintain comprehensive test plans for 3DExperience platform modules and application
• Involve actively in 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), and Validation Reports.
• Ensure validation strategies meet regulatory requirements and company standards.
• Stay updated on relevant changes to Amgens SOPs and ensure validation practices are aligned with evolving standards.
• Assist with UAT, test data preparation and developing work instructions.
• Contribute to test automation scripting, framework maintenance, and CI/CD integration.
• 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.
• Work closely with manager on implementing automation strategies, document all bugs in a tracking tool, and always follow best QA practices.
• Ensure 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 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.

Functional Skills

Must-Have Skills:

• 6-8 years of 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.
• 3+ years of experience in validation in a GxP-regulated environment (pharmaceutical, biotech, medical devices, etc.).
• 2 to 4 years 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)

Education and Professional Certifications

• Masters degree with 4 - 6 years of experience in Software Quality and GxP Validation OR
• Bachelors degree with 6 - 8 years of experience in Software Quality and GxP Validation

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.