Software Quality & Validation Engineer
Amgen
Software Quality & Validation Engineer
Job Description
ABOUT AMGEN
What you will do
- Develop, execute and maintain test scripts for data platforms and custom-built solutions
- Collaborate closely with cross-functional teams to ensure data and analytics products follow validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines
- Actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, Database, and Beta
- Actively involved in release planning and estimate test efforts
- Collaborate and 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
- Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents
- Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards
- Contribute to test automation scripting, framework maintenance, and CI/CD integration
- Execute automated test suites across various layers including data pipelines, APIs, and semantic layers
- 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
What we expect of you
- Master's/Bachelor’s degree with 9-12 years of experience in Computer science, Engineering, IT or related field
Must-Have Skills
- Experience leading software validation projects
- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation
- Hands-on experience executing and analyzing automated test suites
- Familiarity with computer system validation and software validation
- Strong problem-solving and analytical skills
- Excellent communication and teamwork skills
- 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
Compensation
9-12
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
25,000 - 35,000 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 leading software validation projectsintermediate
- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentationintermediate
- Hands-on experience executing and analyzing automated test suitesintermediate
- Familiarity with computer system validation and software validationintermediate
- Strong problem-solving and analytical skillsintermediate
- Excellent communication and teamwork skillsintermediate
- 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 9-12 years of experience in Computer science, Engineering, IT or related field (experience)
Responsibilities
- Develop, execute and maintain test scripts for data platforms and custom-built solutions
- Collaborate closely with cross-functional teams to ensure data and analytics products follow validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines
- Actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, Database, and Beta
- Actively involved in release planning and estimate test efforts
- Collaborate and 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
- Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents
- Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards
- Contribute to test automation scripting, framework maintenance, and CI/CD integration
- Execute automated test suites across various layers including data pipelines, APIs, and semantic layers
- 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
Tags & Categories
Software Quality & Validation Engineer
Amgen
Software Quality & Validation Engineer
Job Description
ABOUT AMGEN
What you will do
- Develop, execute and maintain test scripts for data platforms and custom-built solutions
- Collaborate closely with cross-functional teams to ensure data and analytics products follow validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines
- Actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, Database, and Beta
- Actively involved in release planning and estimate test efforts
- Collaborate and 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
- Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents
- Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards
- Contribute to test automation scripting, framework maintenance, and CI/CD integration
- Execute automated test suites across various layers including data pipelines, APIs, and semantic layers
- 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
What we expect of you
- Master's/Bachelor’s degree with 9-12 years of experience in Computer science, Engineering, IT or related field
Must-Have Skills
- Experience leading software validation projects
- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation
- Hands-on experience executing and analyzing automated test suites
- Familiarity with computer system validation and software validation
- Strong problem-solving and analytical skills
- Excellent communication and teamwork skills
- 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
Compensation
9-12
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
25,000 - 35,000 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 leading software validation projectsintermediate
- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentationintermediate
- Hands-on experience executing and analyzing automated test suitesintermediate
- Familiarity with computer system validation and software validationintermediate
- Strong problem-solving and analytical skillsintermediate
- Excellent communication and teamwork skillsintermediate
- 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 9-12 years of experience in Computer science, Engineering, IT or related field (experience)
Responsibilities
- Develop, execute and maintain test scripts for data platforms and custom-built solutions
- Collaborate closely with cross-functional teams to ensure data and analytics products follow validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines
- Actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, Database, and Beta
- Actively involved in release planning and estimate test efforts
- Collaborate and 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
- Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents
- Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards
- Contribute to test automation scripting, framework maintenance, and CI/CD integration
- Execute automated test suites across various layers including data pipelines, APIs, and semantic layers
- 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
Tags & Categories