Key skills
Instrument Software ValidationComputer System Validation (CSV)GxP regulationsLaboratory instrument validationMedical device validationInstrument integration validationValidation lifecycle documentation (IQ/OQ/PQ)EMA guidelinesGAMP 5Risk assessmentValidation testingLIMSLabWareLabVantageEmpowerChromeleonData integrityElectronic records complianceChange controlCAPAAudit support
About this role
SARACA is a company focused on the validation of software for laboratory instruments. They are seeking a Senior Instrument Software Validation Engineer to ensure compliance with regulatory standards and support the validation of various software systems and instruments.
Responsibilities:
- Validate software installed on laboratory instruments in compliance with EMA and GxP regulations
- Perform validation of laboratory instruments, medical devices, and associated software systems
- Validate instrument integrations and downstream data workflows
- Develop validation protocols, test cases, traceability matrices, and validation summary reports
- Document software configurations, system requirements, and validation activities
- Create infrastructure and data flow diagrams
- Conduct risk assessments using industry best practices and validation methodologies
- Support migration of instrument software management processes to align with organizational IT SOPs
- Collaborate with IT, QA, Validation, and Laboratory Operations teams
Requirements:
- 6+ years of experience in Instrument Software Validation or Computer System Validation (CSV)
- Experience working in GxP-regulated pharmaceutical, biotechnology, medical device, or CRO environments
- Strong understanding of laboratory instrument validation and medical device validation
- Experience validating instrument integrations and downstream workflows
- Expertise in validation lifecycle documentation including IQ/OQ/PQ
- Strong technical writing and documentation skills
- Knowledge of EMA guidelines, GAMP 5, and regulatory compliance requirements
- Experience performing risk assessments and validation testing
- LIMS, LabWare, LabVantage, Empower, Chromeleon, or similar laboratory systems
- Data integrity and electronic records compliance experience
- Change control, CAPA, and audit support experience