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

Validation Engineer - GenAI and Content Automation