IT Validation Specialist (CSV)

A biotech company is seeking a new IT Validation Specialist (CSV) on a long-term contract basis in a Remote capacity. Third-party candidates will NOT BE CONSIDERED! Only direct candidates. About the Opportunity: Schedule: Monday to Friday Hours: 9am to 5pm (40 hours per week) Setting: Remote Responsibilities: Execute the GxP-Regulated computerized system lifecycle, ensuring compliance with regulatory standards, CSV procedures, and Data Integrity requirements Manage and execute all CSV/CSA activities at the site, ensuring compliance with regulatory requirements and internal SOPs Plan, organize, and lead the development and execution of all validation lifecycle documents, including: Validation Plan Requirements Specification Risk Assessment System Impact Assessment Testing Documentation Requirements Traceability Matrix Validation Final Report Work closely with project teams, business partners, and Digital Quality to determine scope of validation activities Conduct periodic reviews of validated computerized systems to ensure continued compliance with regulations and SOPs Participate in change management activities for validated computerized systems as a subject matter expert, including providing thorough impact assessments of proposed changes to ensure no negative impact on system integrity or data compliance Providing support during regulatory and external audits, serving as a subject matter expert for CSV/CSA Qualifications: 4+ years of experience in Computer Systems Validation/Assurance Detailed knowledge of GxP regulations and CSV/CSA principles, including, but not limited to: 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity Familiarity with manufacturing computerized systems, including but not limited to: Clinical applications like EDS, cTMS, eTMF Commercial pharma analytics systems IT CSV and Quality control applications Data Backup/Restore Solutions Asset Management Systems Excellent communication and interpersonal skills, fostering collaboration and building strong relationships with internal and external stakeholders Project management skills with the ability to prioritize tasks, manage deadlines, and track progress effectively Strong attention to detail and a commitment to accuracy and compliance

Created: 2026-03-10