Business Systems and Validation Analyst III
Core
Validate laboratory instrumentation and computerized systems in regulated environments (GxP, EMA) to ensure compliance with regulatory expectations and internal quality standards.
Role type
Senior IC Business Systems and Validation Analyst
Builds
Validated laboratory software systems and instrumentation for clinical research and life sciences
Domain
Life Sciences / Clinical Research / Regulated Laboratory Environments
Required skills
Computerized System Validation (CSV), SDLC documentation, Requirements gathering, Risk assessment, Audit support, SOP authoring, Data integrity principles, Regulatory compliance (EMA/GxP), Technical writing
Preferred skills
Process improvement, Mentoring junior staff, Laboratory instrumentation knowledge, Clinical trial operations
Technologies
SDLC tools, Validation software, MS Office
Responsibilities
Gather and document business and system requirements for laboratory systems; Lead development of SDLC and validation lifecycle documentation; Create and execute validation test cases; Support client, regulatory, and internal audits; Lead process improvement initiatives for validation efficiency; Author and maintain SOPs and compliance documentation; Provide mentorship to junior team members.
Seniority
Senior, hands-on IC with mentorship responsibilities