CSV Lead

Accountabilities

• • Lead CSV and compliance activities for capital and strategic projects involving computerized manufacturing and laboratory systems.
  • Plan, execute, review, and approve validation lifecycle activities and documentation in accordance with GxP requirements, internal procedures, and regulatory expectations.
  • Provide expert guidance on CSV/CSA, SDLC, risk-based validation, system qualification, IQ/OQ/PQ, change control, configuration management, CAPA, deviations, and data integrity.
  • Conduct and review system risk assessments, define appropriate validation strategies, and ensure identified compliance risks have effective mitigation plans.
  • Maintain compliance oversight throughout system implementation, modification, operation, and retirement.
  • Collaborate with Quality, Engineering, Automation, IT/OT, laboratory, business, and project teams to integrate validation requirements throughout project delivery.
  • Support regulatory inspections, internal audits, remediation initiatives, and other compliance activities when required.
  • Promote consistent, risk-based CSV/CSA practices across manufacturing projects and computerized systems.
  • Contribute validation and qualification expertise across systems such as DeltaV Distributed Control Systems, Rockwell or Siemens PLCs, process historians, laboratory automation, and other GxP-regulated manufacturing platforms.

  Requirements

  • 5+ years of professional experience, with strong hands-on Computer System Validation experience in GMP-regulated pharmaceutical or manufacturing environments.
  • Demonstrated experience supporting validation and compliance activities for computerized manufacturing systems.
  • Strong knowledge of validation lifecycle management, CSV/CSA principles, GxP/GMP requirements, SDLC, IQ/OQ/PQ, change control, CAPA, deviation management, risk-based validation, risk management, and data integrity.
  • Proven ability to develop, review, and approve validation documentation and other compliance deliverables.
  • Understanding of FDA, EMA, and international regulatory expectations applicable to computerized systems in regulated environments.
  • Ability to independently assess compliance risks, define practical solutions, and provide guidance or constructive challenge to project teams.
  • Experience with manufacturing automation or IT/OT environments, with exposure to platforms such as DeltaV, Rockwell or Siemens PLCs, process historians, or laboratory automation highly desirable.
  • Previous experience as a CSV Lead, Validation Lead, or senior compliance representative on complex manufacturing or pharmaceutical projects is preferred.
  • Familiarity with modern Computer Software Assurance and risk-based validation approaches.
  • Strong stakeholder-management, communication, leadership, and problem-solving skills, with the ability to work effectively across international and cross-functional teams.
  • Professional fluency in English and the ability to operate autonomously in a remote environment.

  Benefits

  • Freelance / contract engagement.
  • Full-time allocation of approximately 40 hours per week.
  • Expected start date: September 2026.
  • Opportunity to contribute to major pharmaceutical manufacturing and capital projects.
  • Exposure to complex GxP-regulated systems, validation programs, and international compliance requirements.
  • Opportunity to work across multidisciplinary teams spanning Quality, Engineering, Automation, IT/OT, laboratory, and project functions.