Lead Computer Systems Validation Engineer I (Clinical & R&D)

Role: Lead Digital Quality efforts within a GxP-regulated biopharma environment, focusing on computer system validation (CSV) for Quality, Regulatory, and R&D systems. Responsibilities: support validation activities, ensure compliance with applicable regulations and policies (e.g., 21 CFR Part 11, ICH Q7-10), lead risk assessments using tools like GAMP 5, manage validation documentation, support audits and inspections, and provide training. Engage in validation of AI systems and contribute to continuous improvement of validation processes. Requirements: Bachelor's in Computer Science, Life Sciences, Engineering, or related field; 9+ years in Digital Quality with extensive GxP validation experience; strong knowledge of compliance standards, quality systems (e.g., Veeva, TrackWise, ValGenesis), and data integrity. Preferred: experience leading teams, excellent communication, adaptability, and proficiency in enterprise quality platforms. High-Value: focus on pharmaceutical/biotech validation, GxP compliance, AI validation, and cross-functional collaboration. WorkSetup: hybrid Waltham, MA, 3+ days onsite; flexible, requiring some travel and onsite presence.