Computer Systems Validation Specialist III
Core
Leads teams in assessing new and changing computer systems to ensure compliance with company policies and industry guidance, acting as the QA CSV representative for projects.
Role type
Senior IC Computer Systems Validation Specialist
Builds
End-to-end computer system validation life-cycle deliverables and activities for biotech, pharma, or medical device projects.
Domain
Life Sciences (Biotech/Pharma/Medical Devices) + Computer Systems Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk assessment, Change Control management, Deviation and CAPA initiation, Gap assessment, Protocol drafting, GMP documentation revision, SOP maintenance, Engineering document review, Audit support
Preferred skills
Analytical computerized systems validation, 21 CFR Part 11 compliance, ISPE GAMP guidelines
Technologies
21 CFR Part 11, ISPE GAMP
Responsibilities
Conduct risk assessments, review change requests and test scripts, schedule qualification activities, support Customer audits and inspections, mentor junior team members
Seniority
Senior, hands-on IC
