Computer Systems Validation Engineer

Role: Lead Computer System Validation Engineer responsible for shaping and scaling CSV strategies within a GxP environment, ensuring compliance while enabling rapid development. Responsibilities include defining validation frameworks, authoring and executing lifecycle deliverables, leading validation team growth, assessing changes, maintaining validation systems, and supporting audits and regulatory inspections. The role emphasizes risk-based validation, collaboration with IT, Quality, vendors, and business owners, and the integration of automation tools to improve efficiency. Qualifications: Bachelor's degree in engineering, computer science, or related field; significant experience in biotech, pharma, or regulated settings with strong CSV, data integrity, and GxP knowledge; experience supporting audits and validation activities; familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, and risk-based validation principles. Preferred skills include scripting, SQL, test automation, and electronic document management systems. The position may be remote with travel as needed and involves working within a fast-growing biotech company focused on CNS therapies, requiring a self-driven, ownership-oriented mindset.