We are seeking a Computer System Validation (CSV) Expert for a 9-month maternity replacement to join our Laboratory Systems & Digital Expertise team at our Biotech Development Center site. The role supports digital compliance activities and the lifecycle management of computerized systems (e.g., Empower, NuGenesis, and GLIMS - LabVantage) within the Analytical Development Biologics (ADB) team. The successful candidate will work under supervision, perform operational tasks, and take on growing responsibilities as experience is gained, helping ensure data integrity, traceability, and readiness for audits and inspections.
Responsibilities:
• Support digital compliance and CSV activities, including document preparation (URS, risk assessments, validation protocols, and reports in the ValGenesis system) and assist during inspections as a basic Subject Matter Expert (SME).
• Collaborate with QC, QA, and IT to ensure electronic systems comply with GMP/GxP and 21 CFR Part 11 requirements.
• Assist and contribute to Change Control management and risk assessments related to system and process changes.
• Provide operational support for Master Data creation and the validation of laboratory digital systems and methods (e.g., GLIMS/GCDS-Empower/SDMS), contributing to data quality improvements.
• Prepare supporting documentation, contribute to SOPs and guidelines, and support audit readiness activities.
• Participate in team meetings, gather requirements, and contribute to continuous improvement plans in compliance and data integrity.
• Contribute alongside team members to digital projects driving continuous innovation in ADB labs.
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