Computer System Validation (CSV) Engineer
carlton national resourcesWakefield, MA
Computer System Validation (CSV) Engineer
carlton national resourcesWakefield, MA
yesterday
Industries
Other Scientific and Technical Consulting ServicesComputer Systems Design ServicesEngineering ServicesAbout the role
Computer System Validation (CSV) Engineer Position Overview: The Computer System Validation (CSV) Engineer is responsible for the validation of computerized systems and infrastructure within regulated environments. This role involves developing and executing validation protocols to ensure compliance with 21 CFR Part-11, Annex-11, and other regulatory standards.
Key Responsibilities:
Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices.
Manage and update validation activities, ensuring alignment with day-to-day operations and project work.
Review and provide feedback on System Delivery Life Cycle (SDLC) documents, ensuring adherence to Standard Operating Procedures (SOPs).
Author and update SOPs, templates, and related documentation to support ongoing CSV compliance.
Required Qualifications:
Bachelor's degree in Computer Science, Life Sciences, or related field.
5+ years of experience in computer system validation within life sciences.
Knowledge of CSV regulatory standards (21 CFR Part-11, Annex-11, GAMP5).
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JOB OVERVIEW
Experience level
Lead
Location
Wakefield, MA
Occupation
Validation Engineers
Industry
Other Scientific and Technical Consulting Services
Posted
yesterday
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