CSV Lead

Do you want to contribute directly to the production of high-quality medicines that reach over 140 countries, positively impacting global healthcare?

NES Fircroft is seeking an

experienced CSV Lead

with 5 to 10+ years in Computer System Validation (CSV) within GMP-regulated environments.

LENGTH : Contract until the end of the year with possibility of renewal

RESPONSIBILITIES Develop and maintain the CSV Master Plan aligned with the VMP. Build and manage a GxP system inventory with GMP relevance and audit status. Perform system impact assessments and define validation scope. Apply GAMP 5 principles for system categorization, risk assessments, and validation documentation. Lead validation of QMS, SCADA/BMS/EMS, SAP or other ERP systems, and analytical software (e.g., Waters HPLC, Labguru). Support facility startup activities and regulatory inspections. Collaborate with QA, IT, and business teams to ensure compliant validation strategies. Drive continuous improvement of CSV processes and documentation. REQUIREMENTS 5–10+ years of CSV experience in GMP-regulated environments. Proven ability to build and execute CSV strategies and documentation from scratch. Hands-on validation experience with QMS, data acquisition systems, ERP systems, and analytical software. Strong knowledge of GAMP 5, Annex 11, and 21 CFR Part 11. Experience in facility startup and regulatory inspection readiness. Ability to create system inventories and conduct impact assessments. Solid understanding of risk-based validation and scalable validation approaches.

No relocation or Visa sponsorship for this role according to client's request.