Associate PLM Quality & Validation Engineer
Amgen
Associate PLM Quality & Validation Engineer
Job Description
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.
What you will do
- 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, RTM, 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
- Bachelor’s degree and 3 to 5 years experience in Software Quality and GMP Validation
- 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
Must-Have 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
- 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
Good-to-Have Skills
- Good-to-Have Skills: Understanding of 3DExperience platform architecture, modules, and integration points is highly desirable
Locations
- Hyderabad, India
Salary
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
- 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 solutionsintermediate
- Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.)intermediate
- Overall 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
- Good-to-Have Skills: 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
- Soft Skills: 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
- Bachelor’s degree and 3 to 5 years experience in Software Quality and GMP Validation (experience)
- 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)
- Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.) (experience)
- Overall experience in developing, executing and analyzing QA & Test Automation (experience)
- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation (experience)
- Experience with computer system validation and software validation (experience)
Responsibilities
- 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, RTM, 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
Tags & Categories
Answer 10 quick questions to check your fit for Associate PLM Quality & Validation Engineer @ Amgen.
10 Questions
~2 Minutes
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Associate PLM Quality & Validation Engineer
Amgen
Associate PLM Quality & Validation Engineer
Job Description
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.
What you will do
- 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, RTM, 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
- Bachelor’s degree and 3 to 5 years experience in Software Quality and GMP Validation
- 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
Must-Have 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
- 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
Good-to-Have Skills
- Good-to-Have Skills: Understanding of 3DExperience platform architecture, modules, and integration points is highly desirable
Locations
- Hyderabad, India
Salary
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
- 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 solutionsintermediate
- Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.)intermediate
- Overall 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
- Good-to-Have Skills: 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
- Soft Skills: 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
- Bachelor’s degree and 3 to 5 years experience in Software Quality and GMP Validation (experience)
- 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)
- Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.) (experience)
- Overall experience in developing, executing and analyzing QA & Test Automation (experience)
- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation (experience)
- Experience with computer system validation and software validation (experience)
Responsibilities
- 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, RTM, 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
Tags & Categories
Answer 10 quick questions to check your fit for Associate PLM Quality & Validation Engineer @ Amgen.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs