CSV Engineer

Job Title

5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or global regulated environment with good understanding of GxP standards and risk-based validation. Experience in writing and executing documentation for all aspects of the validation deliverables (e.g., requirements, compliance/validation plans, test protocols, test summary reports, and compliance/validation reports. Experience in reviewing system test and user acceptance test scripts, traceability matrix, and design specs. Experience in QA methodologies, designing, reviewing, and approving test plans, system/UAT test scripts, and test procedures. Strong verbal and written communication skills. Ability to work as a team player, lead a team, or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously. Ability to provide validation guidance, timely reviews, and escalations to TQ management Diverse Lynx LLC is an equal employment opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence, and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.