Software Quality & Validation Engineer
Software Quality & Validation Engineer
India - Hyderabad APLICAR AHORAABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
ABOUT THE ROLE
Role Description:
We seek a skilled Software Test engineer to develop, execute and maintain the test scripts for data platforms and custom-built solutions. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Front-end testing, Back-end testing, API testing, and test automation. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and comply with Amgen’s 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, 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.
Functional Skills:
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 is a plus.
Strong problem-solving and analytical skills.
Excellent communication and teamwork skills.
Good-to-Have Skills:
Experience with automated and computer-controlled systems validation (21 CFR Part 11)
Education and Professional Certifications
Master's/Bachelor’s degree with 9-12 years of experience in Computer science, Engineering, IT or related field
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.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.