Dotmatics

Validation Engineer

Dotmatics

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

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About the role

  • Develop and execute validation protocols (IQ/OQ/PQ) for software systems and tools used in GxP environments
  • Author and maintain validation documentation including validation master plans, protocols, reports, and standard operating procedures
  • Follow comprehensive validation plans following GAMP 5 principles, including risk-based approaches to validation activities
  • Ensure all validation activities comply with 21 CFR Part 11, GAMP 5, ISO 9001 and applicable FDA guidance
  • Maintain validation documentation in accordance with quality management system requirements
  • Support audit and inspection readiness through comprehensive validation records
  • Partner with Software Engineering, Product Management and Quality Management on developing and reviewing validation artifacts
  • Support Change Control activities and assess validation impact of system changes

Requirements

  • Experience in software validation, computer system validation (CSV), or related quality/compliance role within a regulated life sciences environment (pharma, biotech, or medical device)
  • Strong understanding of GAMP 5 principles and risk-based validation approaches
  • Working knowledge of 21 CFR Part 11 requirements for electronic records and signatures
  • Familiarity with ISO 9001 quality management system principles
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
software validationcomputer system validationvalidation protocolsvalidation documentationrisk-based validationGAMP 521 CFR Part 11ISO 9001validation master plansstandard operating procedures
Soft Skills
collaborationcommunicationattention to detailorganizational skillsaudit readiness