CSV Specialist

Job Description This role is essential for ensuring the quality and compliance of computerized systems within a brand-new biological drug substance manufacturing facility, helping to shape a reliable and efficient validation environment. Responsibilities Own and manage the end-to-end CSV lifecycle for computerized systems Ensure computerized systems comply with GMP, GAMP 5, and applicable regulatory standards Review and approve validation documentation within CSV scope Manage CSV-related deviations, CAPAs, and change controls Act as the CSV point of contact between Quality, IT, Automation, and Engineering Support inspection readiness and regulatory interactions related to computerized systems Essential Requirements Bachelor's or Master's degree in a relevant scientific or technical field. Minimum 5 years of experience within the pharmaceutical or biotechnology industry. Core technical expertise in Computerized System Validation (CSV) principles and GAMP 5. Required hands-on skills in managing deviations, CAPAs, and change controls specifically related to CSV scope. Required scientific/technical knowledge of GMP standards and the validation of automated systems (e.g., PLC, SCADA, or MES). Languages: Fluency in both French and English is mandatory. Familiarity with enterprise platforms like ERP, MES, LIMS, or QMS. Preferred Requirements Experience with Veeva Vault or similar Quality Management Systems (QMS). Advanced knowledge of Data Integrity (DI) requirements and 21 CFR Part 11. Direct experience participating in Health Authority audits and inspections. Proven ability to guide cross-functional stakeholders on GMP-compliant validation processes. High level of agility and stress resilience in a fast-paced project environment. Practicalities Start Date: February 1st Contract Duration: 12 months Location: Braine-l'Alleud, Belgium Additional: Extension possible based on performance and project needs. Interested? Interviews and offers can move quickly. Send your CV to Oluali Titelman at o.titelman@panda-int.com or call +31 (0)20 2044 502 today to secure your spot in the process.