Validation Engineer - GenAI and Content Automation

We are seeking an experienced Validation Engineer to join our team supporting a GxP platform that automates regulatory filings. This role is key to ensuring compliance, driving efficiency, and fostering innovation in data validation processes. You will collaborate closely with developers, business analysts, and stakeholders to validate technical requirements and support continuous improvements and automation within the program. Key Roles & Responsibilities Develop detailed test plans and validation strategies aligned with project specifications and regulatory requirements. Execute manual and automated testing including functional, regression, and performance tests. Document and report defects; collaborate with development teams to resolve issues effectively. Maintain comprehensive records of test cases, plans, and results to ensure full traceability and compliance with GxP standards. Validate test scenarios against acceptance criteria and customer expectations. Ensure all systems comply with regulatory requirements covering data integrity, traceability, and reliability. Identify and implement opportunities to enhance testing efficiency and automation. Evaluate and adopt new tools and technologies to improve automation capabilities. Keep validation documentation current and compliant with GxP and change management policies. Stay abreast of industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert validation support to optimize quality, efficiency, and cost-effectiveness for application development and troubleshooting. Basic Qualifications and Experience Master's degree with 1 to 3 years experience in Life Sciences, Biotechnology, Pharmacology, or Information Systems, OR Bachelor's degree with 3 to 5 years experience in the above fields, OR Diploma with 7 to 9 years experience in the above fields. Functional Skills Must-Have: Strong problem-solving skills with a passion for addressing complex challenges in drug discovery through technology. Experience working within Agile software development methodologies (Scrum). Excellent communication skills with the ability to confidently engage senior leadership. Proven experience writing requirements for modern web application development. Solid understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11. Proficiency in automation tools, data systems, and validation software. Good-to-Have: Expertise in scientific domain areas and associated technology requirements. Understanding of scientific software systems strategy, governance, and infrastructure. Familiarity with low-code/no-code test automation platforms. Experience with technical thought leadership. Ability to translate technical concepts into business language. Knowledge of DevOps, Continuous Integration (CI), and Continuous Delivery (CD) practices. Professional Certifications SAFe for Teams certification (preferred). Soft Skills Self-motivated with ability to work independently under minimal supervision. Strong mentoring and oversight capabilities; effective delegation skills. Excellent analytical skills including gap and fit assessments. Strong verbal and written communication skills. Ability to collaborate effectively with global, virtual teams. Capable of managing multiple priorities simultaneously. Team player focused on achieving shared goals. Strong presentation and public speaking abilities.