Computer System Validation Specialist
Core
Maintain the Computer System Validation (CSV) framework, policies, and templates to ensure digital systems comply with regulatory requirements and internal SOPs.
Role type
Senior IC Computer System Validation Specialist
Builds
Validated digital systems and compliance documentation for clinical research platforms
Domain
Clinical research / Pharma / Biotech / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV) framework expertise, IQ/OQ/PQ execution, regulatory compliance knowledge (ICH GCP, FDA 21 CFR Part 11, EMA, GAMP 5), risk assessment, traceability matrix creation, vendor qualification, data integrity principles, cloud-based solution validation
Preferred skills
ICH GCP certification, GAMP 5 certification
Technologies
Cloud-based solutions
Responsibilities
Lead validation activities (IQ/OQ/PQ) across digital systems; Author and review validation plans, risk assessments, and traceability matrices; Ensure compliance with ICH GCP, FDA 21 CFR Part 11, EMA, GAMP 5; Participate in vendor qualifications; Train staff and promote a quality focused culture
Seniority
Senior, hands-on IC