Canton, MA - Direct Hire
The Computer System Validation Engineer will be designated to support validations for two CGMP facilities. The engineer will be responsible for researching, developing, and executing Installation, Operational, Performance Qualification, Requalification and Revalidation protocols for stand-alone Computer Systems (local server(s) and cloud based) and embedded computer systems in manufacturing equipment (as applicable). The Engineer will write and execute protocols and maintain records for validations.
- Prepares protocols and reports for initial validation, requalification, and revalidation work
- Assists in the development of URS and FRS documents to identify computer system requirements with end users (as applicable).Performs testing using standard computer qualification concepts, practices and procedures of the CGMP process and is consistent with established testing methodologies.
- Responsible for the generation and maintenance of traceability matrices.
- Reviews and assesses vendor supplied computer system validation documentation for alignment with requirements. Generates gap protocols where deficiencies are identified.
- Reviews and summarizes the output of completed executed computer system scripts for vendor supplied documentation.
- Participate in the creation and/or review of Standard Operating Procedures (SOPs) for computer system projects
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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