Senior Computer System Validation Engineer

March 20, 2024
Reference key: es11535
Deadline date:

Job Description

  • Negotiable
  • Permanent
  • Galway

Senior Computer System Validation Engineer required to Lead Quality, Compliance & CSV by innovative MedTech company in Galway


  • Lead Quality and Compliance activities in relation to Software projects.
  • Ensure Quality and Compliance with respect to Software/Computerised Systems projects.
  • Support, guide and monitor projects, to ensure that approved software development standards, processes and procedures are adhered to, while also guiding the adoption of industry best-practices.
  • Support supplier assessment for software system providers.
  • Lead continuous improvement projects for Computerised System Validation / Assurance.
  • Ensure that processes, SOPs and forms for computer systems control and validation continue to meet the requirements of relevant regulations and are fit for purpose.
  • Quality review and author computer system validation documentation; change controls, test scripts, protocols, reports.
  • Train, develop and manage SQA engineers to ensure objectives are communicated and delivered per the business requirements.


  • BSc. Degree in Computer Science or Quality Assurance, or equivalent industrial experience
  • At least 8 years’ experience working in a regulated device or pharmaceutical company of which at least five years must be within a quality assurance or related role.
  • Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR Parts 11 & 820.
  • Familiarity with GAMP5 Guideline for “Risk Based approach to GxP Compliant Computerised systems”.
  • Familiarity with Agile/SCRUM practices for software implementation and product development.
  • Ability to work within a team environment to achieve agreed company goals.
  • Ability to communicate effectively with all levels of the company.
  • Ability to meet deadlines and follow through on assigned deliverables.
  • Attention to detail.