{"schemaVersion":"jobsearcher.job.v1","id":"69df44b22a005797777bc9b7","url":"https://jobsearcher.com/jobs/69df44b22a005797777bc9b7","canonicalUrl":"https://jobsearcher.com/jobs/69df44b22a005797777bc9b7","title":"Validation Engineer (CSV)","description":"Job Overview:\nWe are seeking highly skilled technical professionals capable of providing commissioning and qualification services within the Pharmaceuticals, Biotechnology, and Medical Devices Manufacturing industries.\nThe Computer System Validation (CSV) Specialist/Engineer will play a crucial role in the development and execution of software and equipment qualification processes.\nResponsibilities and Duties:\nGenerate and execute validation documents, including protocol creation and testing within the bio-pharmaceutical industry.\nCreate and seek approval for validation documents such as C&Q Plan, URS, Design Specs, Requirements Traceability Matrix, and Summary Reports tailored for the Biopharmaceutical industry.\nRevise Design Specifications as necessary to align with new design requirements.\nDevelop qualification protocols for new or modified manufacturing equipment, utilities, and facilities.\nPrepare comprehensive summary reports based on the results of validation and qualification tests, as well as reviews of procedures and protocols.\nProvide support during implementation, collaborating with affected departments and personnel.\nActively participate in progress meetings to ensure affected departments are kept up to date with project achievements and communicate any action items necessary to maintain project schedules.\nQualifications and Skills:\nBachelor of Science in Engineering or equivalent\nExperience in the Bio/Pharmaceutical industry.\nProficient in Commissioning & Qualification documentation.\nFamiliarity with CSV regulations and guidelines, including cGMP, ISPE GAMP process, 21 CFR Part 11, 21 CFR 211.68, and Data Integrity.\nStrong analytical thinking and problem-solving skills.\nTeam-oriented, capable of collaborating with technical experts, design teams, and other departments.\nQuality and results-oriented mindset.\nComputer literate with excellent verbal and written communication skills in both English and Spanish.\nExceptional attention to detail, with the ability to independently proof work for accuracy.\nJob Type: Full-time\nEducation:\nBachelor's (Required)\nExperience:\nComputer Systems Validation (CSV): 5 years (Required)\nLanguage:\nSpanish (Required)\nEnglish (Required)\nAbility to Commute:\nJuncos, PR 00777 (Required)\nAbility to Relocate:\nJuncos, PR 00777: Relocate before starting work (Required)\nWork Location: In person","company":"Avante Engineering","rawCompany":"avante engineering","city":"Juncos","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-04-12T20:54:52.320Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer (CSV)","description":"Job Overview:\nWe are seeking highly skilled technical professionals capable of providing commissioning and qualification services within the Pharmaceuticals, Biotechnology, and Medical Devices Manufacturing industries.\nThe Computer System Validation (CSV) Specialist/Engineer will play a crucial role in the development and execution of software and equipment qualification processes.\nResponsibilities and Duties:\nGenerate and execute validation documents, including protocol creation and testing within the bio-pharmaceutical industry.\nCreate and seek approval for validation documents such as C&Q Plan, URS, Design Specs, Requirements Traceability Matrix, and Summary Reports tailored for the Biopharmaceutical industry.\nRevise Design Specifications as necessary to align with new design requirements.\nDevelop qualification protocols for new or modified manufacturing equipment, utilities, and facilities.\nPrepare comprehensive summary reports based on the results of validation and qualification tests, as well as reviews of procedures and protocols.\nProvide support during implementation, collaborating with affected departments and personnel.\nActively participate in progress meetings to ensure affected departments are kept up to date with project achievements and communicate any action items necessary to maintain project schedules.\nQualifications and Skills:\nBachelor of Science in Engineering or equivalent\nExperience in the Bio/Pharmaceutical industry.\nProficient in Commissioning & Qualification documentation.\nFamiliarity with CSV regulations and guidelines, including cGMP, ISPE GAMP process, 21 CFR Part 11, 21 CFR 211.68, and Data Integrity.\nStrong analytical thinking and problem-solving skills.\nTeam-oriented, capable of collaborating with technical experts, design teams, and other departments.\nQuality and results-oriented mindset.\nComputer literate with excellent verbal and written communication skills in both English and Spanish.\nExceptional attention to detail, with the ability to independently proof work for accuracy.\nJob Type: Full-time\nEducation:\nBachelor's (Required)\nExperience:\nComputer Systems Validation (CSV): 5 years (Required)\nLanguage:\nSpanish (Required)\nEnglish (Required)\nAbility to Commute:\nJuncos, PR 00777 (Required)\nAbility to Relocate:\nJuncos, PR 00777: Relocate before starting work (Required)\nWork Location: In person","datePosted":"2026-04-12T20:54:52.320Z","dateModified":"2026-04-12T20:54:52.320Z","hiringOrganization":{"@type":"Organization","name":"Avante Engineering","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Juncos","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"69df44b22a005797777bc9b7"},"url":"https://jobsearcher.com/jobs/69df44b22a005797777bc9b7"}}