{"schemaVersion":"jobsearcher.job.v1","id":"ea22020ef787531ba9ee7bcd","url":"https://jobsearcher.com/jobs/ea22020ef787531ba9ee7bcd","canonicalUrl":"https://jobsearcher.com/jobs/ea22020ef787531ba9ee7bcd","title":"CSV Project Engineer","description":"IDEA Solutions is seeking a CSV Project Engineer to support computer system validation activities within regulated environments. The ideal candidate will have experience with CSV documentation, regulatory requirements, and validation life-cycle activities.\n\nResponsibilities:\n\n* Develop, review, and execute computer system validation protocols and documentation.\n* Prepare validation plans, risk assessments, test scripts, traceability matrices, and summary reports.\n* Support system implementation, upgrades, changes, and periodic reviews.\n* Ensure compliance with GxP, GAMP 5, FDA 21 CFR Part 11, and applicable regulatory requirements.\n* Identify and document deviations and support corrective actions.\n* Collaborate with Quality, Engineering, IT, and other project stakeholders.\n* Maintain accurate and complete validation records.\n* Support validation activities using Kneat.\n\nRequirements:\n\n* Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.\n* Minimum of 2–3 years of experience in Computer System Validation.\n* Experience working in pharmaceutical, biotechnology, medical-device, or other regulated environments.\n* Knowledge of GxP, GAMP 5, and FDA 21 CFR Part 11.\n* Basic knowledge of the Kneat platform.\n* Strong written and verbal communication skills in English and Spanish.\n* Strong organizational, analytical, and documentation skills.\n* Ability to work independently and collaborate with multidisciplinary teams.\n\nJob Details:\n\n* Full-time position\n* On-site in San Juan, Puerto Rico\n* Annual salary range: $67,000–$85,000, depending on qualifications and experience\n\nBenefits:\n\n* Health insurance\n* 401(k) retirement plan\n\nTipo de puesto: Tiempo completo\n\nBeneficios:\n* \n* \n\nLugar de trabajo: Híbrido en San Juan, PR 00907","company":"Ideal Solutions","rawCompany":"ideal solutions","city":"San Juan","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-09-04T11:46:29.017Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541990","title":"All Other Professional, Scientific, and Technical Services","slug":"all-other-professional-scientific-and-technical-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"CSV Project Engineer","description":"IDEA Solutions is seeking a CSV Project Engineer to support computer system validation activities within regulated environments. The ideal candidate will have experience with CSV documentation, regulatory requirements, and validation life-cycle activities.\n\nResponsibilities:\n\n* Develop, review, and execute computer system validation protocols and documentation.\n* Prepare validation plans, risk assessments, test scripts, traceability matrices, and summary reports.\n* Support system implementation, upgrades, changes, and periodic reviews.\n* Ensure compliance with GxP, GAMP 5, FDA 21 CFR Part 11, and applicable regulatory requirements.\n* Identify and document deviations and support corrective actions.\n* Collaborate with Quality, Engineering, IT, and other project stakeholders.\n* Maintain accurate and complete validation records.\n* Support validation activities using Kneat.\n\nRequirements:\n\n* Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.\n* Minimum of 2–3 years of experience in Computer System Validation.\n* Experience working in pharmaceutical, biotechnology, medical-device, or other regulated environments.\n* Knowledge of GxP, GAMP 5, and FDA 21 CFR Part 11.\n* Basic knowledge of the Kneat platform.\n* Strong written and verbal communication skills in English and Spanish.\n* Strong organizational, analytical, and documentation skills.\n* Ability to work independently and collaborate with multidisciplinary teams.\n\nJob Details:\n\n* Full-time position\n* On-site in San Juan, Puerto Rico\n* Annual salary range: $67,000–$85,000, depending on qualifications and experience\n\nBenefits:\n\n* Health insurance\n* 401(k) retirement plan\n\nTipo de puesto: Tiempo completo\n\nBeneficios:\n* \n* \n\nLugar de trabajo: Híbrido en San Juan, PR 00907","datePosted":"2026-09-04T11:46:29.017Z","dateModified":"2026-09-04T11:46:29.017Z","hiringOrganization":{"@type":"Organization","name":"Ideal Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"San Juan","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ea22020ef787531ba9ee7bcd"},"url":"https://jobsearcher.com/jobs/ea22020ef787531ba9ee7bcd"}}