Develop and execute validation strategies for GxP-relevant systems in accordance with GAMP 5 and biotech/pharma industry standards
Author and review validation documentation such as validation plans, IQ/OQ/PQ protocols, traceability matrices, and summary reports
Ensure systems comply with electronic records and signature regulations (21 CFR Part 11, Annex 11)
Perform risk assessments for new systems, upgrades, and system changes, and integrate validation into the change management process
Maintain audit-ready documentation and support both internal and external audits, including regulatory inspections
Address audit findings and contribute to corrective and preventive actions (CAPAs)
Collaborate with QA, regulatory, manufacturing, and IT stakeholders as well as external vendors to align on compliance and validation requirements
Provide training and guidance on validation procedures, regulatory expectations, and documentation standards

Bachelor's or Master's degree in Life Sciences, Engineering, Computer Science, or similar
5+ years of experience in IT compliance, system validation, or QA in biotech, pharma, or another regulated industry
Solid knowledge of GxP, GAMP 5, 21 CFR Part 11, and EU Annex 11
Experience with computerized system validation (CSV) and quality documentation
Familiarity with enterprise platforms like ERP, MES, LIMS, or QMS
Excellent analytical, documentation, and communication skills
Full professional proficiency in English.

Compliance and Validation Specialist

Key skills