HYDERABAD · FULLTIME
PLM Software Quality & Validation Engineer
Amgen
Hyderabad · onsite · Posted 44d ago
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Undisclosed5–9 yrsfulltimeHyderabad
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Section · 01
About this role
Roles & Responsibilities:
Functional Skills:
Good-to-Have Skills:
- 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.
- Implement automated test suites across various modules in 3DEXPERIENCE.
- Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis.
- Collaborate with multi-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.
- Find opportunities for process improvements in validation activities.
- Know the latest on new technologies, validation trends, and industry standard processes to improve validation efficiencies.
- Collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution.
Basic Qualifications:
- Master's degree / Bachelor's degree and 5 to 9 years of experience in Software Quality and GMP Validation
Preferred Qualifications:
Functional Skills:
Must-Have Skills:
- Experience in Quality Assurance (QA) testing with 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)
- 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.
Sourced from naukri
Section · 02
Skills
QA AnalysisAgileTroubleshootingtest datasoftware qualityweb applicationprotocolsplatform architecturepresentation skills3Dexperiencesoftware testingmanual testingGMPQuality AssuranceAutomation TestingCi/Cd
Section · Company
About Amgen
Amgen
Biotechnology
1.5k+
employees
1980
46 years old
Hyderabad, Telangana
India
About
Amgen operates in the biotechnology sector, developing and delivering advanced medicines to address critical health challenges globally.
Industries
BiotechnologyBiotech & Life sciences
Employee ratings
173 reviews
2.8/ 5
Culture
2.7
Career growth
2.5
Work-life
2.8
Employees rate it well for
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