Qualifications

• 5-10 years of experience in CSV/validation within regulated laboratories or life sciences
• In-depth knowledge of EMA Annex 11 and 21 CFR Part 11
• Expertise in data integrity principles (ALCOA+) and GAMP 5
• Proven experience in authoring URS, FRS, DS, RTM, IQ/OQ/PQ and validation summary reports
• Background with LIMS, ELN, CDS, or instrument control software
• Familiarity with test and quality tools like Client ALM, Jira, ValGenesis, or Veeva
• Strong technical writing and communication skills.

Responsibilities

• Plan and execute risk-based computer system validation using the CSA approach aligned to GAMP 5.
• Validate laboratory instrument software and author necessary documentation such as URS and FRS.
• Design data flow diagrams to document infrastructure, security measures, and audit trails.
• Capture and maintain business and technical requirements with a traceability matrix.
• Execute testing cycles, manage defect logging, and oversee remediation processes.
• Ensure compliance through change control, periodic review, and training effectiveness.
• Collaborate with cross-functional teams including QA, IT, and Lab, ensuring clear communication among stakeholders.

Benefits

• Opportunity to work with cutting-edge laboratory technologies
• Collaborative environment with cross-functional teams
• Engagement in compliance with global regulations and standards
• Development of audit-ready documentation
• Support for professional growth and continuous learning opportunities.