Validation Engineer

3 days ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

Roles & Responsibilities:

- Develop comprehensive test plans and strategies based on project specifications and requirements.
- Perform manual and automated testing of software applications, including functional, regression, and performance testing.
- Document and report defects identified during testing and collaborate with development teams for resolution.
- Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance.
- Validate test scenarios against feature acceptance criteria and customer expectations.
- Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability.
- Identify opportunities to enhance testing efficiency and minimize manual efforts.
- Evaluate and adopt tools and technologies to improve automation capabilities.
- Keep validation documentation updated and aligned with GxP standards.
- Ensure strict adherence to change management processes for validated systems.
- Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP.
- Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms.

Basic Qualifications and Experience:

- Master's degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR
- Bachelor's degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR
- Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience

Functional Skills:

Must-Have Skills:

- Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology
- Experience with Agile software development methodologies (Scrum)
- Excellent communication skills and the ability to interface with senior leadership with confidence and clarity
- Experience in writing requirements for development of modern web application
- Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11.
- Proficiency in automation tools, data systems, and validation software.

Good-to-Have Skills:

- Demonstrated expertise in a scientific domain area and related technology needs
- Understanding of scientific software systems strategy, governance, and infrastructure
- Familiarity with low-code, no-code test automation software
- Technical thought leadership
- Able to communicate technical or complex subject matters in business terms
- Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology

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