PLM Software Quality & Validation Engineer
Amgen
PLM Software Quality & Validation Engineer
Job Description
ABOUT AMGEN
What you will do
- 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 Amgen’s 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
What we expect of you
- Master’s / Bachelor's degree with 5 - 8 years of experience in Software Quality and GxP Validation
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
- 3+ years of experience in validation in a GxP-regulated environment (pharmaceutical, biotech, medical devices, etc.)
- 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
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
15,000 - 25,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Experience in Quality Assurance (QA) testing with at least 3 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutionsintermediate
- 3+ years of experience in validation in a GxP-regulated environment (pharmaceutical, biotech, medical devices, etc.)intermediate
- Experience in developing, executing and analyzing QA & Test Automationintermediate
- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentationintermediate
- Experience with computer system validation and software validationintermediate
- Strong problem-solving and analytical skillsintermediate
- Understanding of 3DExperience platform architecture, modules, and integration points is highly desirableintermediate
- Experience with automated and computer-controlled systems validation (21 CFR Part 11)intermediate
- Excellent analytical and troubleshooting skillsintermediate
- Strong verbal and written communication skillsintermediate
- Ability to work effectively with global, virtual teamsintermediate
- High degree of initiative and self-motivationintermediate
- Ability to manage multiple priorities successfullyintermediate
- Team-oriented, with a focus on achieving team goalsintermediate
- Ability to learn quickly, be organized and detail orientedintermediate
- Strong presentation and public speaking skillsintermediate
Required Qualifications
- Master’s / Bachelor's degree with 5 - 8 years of experience in Software Quality and GxP Validation (experience)
Responsibilities
- 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 Amgen’s 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
Tags & Categories
PLM Software Quality & Validation Engineer
Amgen
PLM Software Quality & Validation Engineer
Job Description
ABOUT AMGEN
What you will do
- 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 Amgen’s 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
What we expect of you
- Master’s / Bachelor's degree with 5 - 8 years of experience in Software Quality and GxP Validation
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
- 3+ years of experience in validation in a GxP-regulated environment (pharmaceutical, biotech, medical devices, etc.)
- 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
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
15,000 - 25,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Experience in Quality Assurance (QA) testing with at least 3 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutionsintermediate
- 3+ years of experience in validation in a GxP-regulated environment (pharmaceutical, biotech, medical devices, etc.)intermediate
- Experience in developing, executing and analyzing QA & Test Automationintermediate
- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentationintermediate
- Experience with computer system validation and software validationintermediate
- Strong problem-solving and analytical skillsintermediate
- Understanding of 3DExperience platform architecture, modules, and integration points is highly desirableintermediate
- Experience with automated and computer-controlled systems validation (21 CFR Part 11)intermediate
- Excellent analytical and troubleshooting skillsintermediate
- Strong verbal and written communication skillsintermediate
- Ability to work effectively with global, virtual teamsintermediate
- High degree of initiative and self-motivationintermediate
- Ability to manage multiple priorities successfullyintermediate
- Team-oriented, with a focus on achieving team goalsintermediate
- Ability to learn quickly, be organized and detail orientedintermediate
- Strong presentation and public speaking skillsintermediate
Required Qualifications
- Master’s / Bachelor's degree with 5 - 8 years of experience in Software Quality and GxP Validation (experience)
Responsibilities
- 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 Amgen’s 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
Tags & Categories