Computer System Validation Engineer

You will be working as a Manual + Computer System Validation Lead at Apexon, a digital-first technology services firm that specializes in accelerating business transformation and delivering human-centric digital experiences. In this role, you will be responsible for leading validation efforts in an Agile environment, focusing on manual testing, validation strategy, and documentation. Your expertise in quality assurance within regulated environments will be crucial as you guide and mentor team members while ensuring the delivery of high-quality solutions. Key Responsibilities - Lead and manage validation/testing efforts for critical programs in an Agile environment. - Develop and review key test documentation such as Test Plans, RTMs, Test Strategies, Test Data, Bug Reports, and Test Execution Reports. - Design, execute, and maintain test cases, efficiently track and resolve defects. - Guide and mentor team members in validation best practices and documentation standards. - Collaborate with cross-functional teams to ensure quality deliverables. - Utilize test management tools like JIRA and ALM for documentation and defect lifecycle tracking. - Conduct various manual testing techniques including Functional, Regression, and System Testing. - Perform database testing and validate backend integrity using SQL. - Ensure compliance with applicable validation standards and regulatory guidelines. Required Skills & Qualifications - Minimum of 8+ years of QA/Validation experience, with at least 2-3 years in a lead capacity. - Familiarity with 21 CFR Part 11 or similar regulatory frameworks. - Deep expertise in manual testing, test design, and documentation. - Strong understanding of defect management, prioritization, and triage processes. - Proficiency in JIRA and ALM for test and defect tracking. - Hands-on experience with Agile/Scrum methodologies. - Working knowledge of Database Testing and SQL. - Domain experience in Life Sciences, Healthcare, or Clinical Trials. Additional Attributes - Proven ability to balance leadership responsibilities with individual contributions. - Excellent communication, documentation, and stakeholder management skills. - Self-motivated, detail-oriented, and accountable. Apexon is committed to diversity and inclusion and has been certified by Great Place to Work across multiple regions. As part of our team, you will have access to various perks and benefits designed to support your personal and professional growth, as well as your overall well-being and that of your loved ones.,