Ecocareers ยท 2 months ago
CSV and Validation Engineer
United States
Full-time
Remote
Senior Level
5+ years expEcocareers is a company that specializes in laboratory informatics and validation services. They are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms, focusing on risk-based validation planning and execution.
Staffing & Recruiting
Responsibilities
Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5
Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports
Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails
Capture business and technical requirements; maintain a bidirectional requirements traceability matrix
Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections
Ensure change control, periodic review, training effectiveness, and release readiness for validated systems
Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates
Qualification
Required
5 to 10+ years in CSV/validation within regulated labs or life sciences
Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5
Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports
Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware
Proficiency with test and quality tools such as Client ALM/Jira/Xray, ValGenesis, Veeva, MasterControl, or TrackWise
Excellent technical writing, organization, and cross-functional communication
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase