{"schemaVersion":"jobsearcher.job.v1","id":"1bc53e0f6297d570b10d3586","url":"https://jobsearcher.com/jobs/1bc53e0f6297d570b10d3586","canonicalUrl":"https://jobsearcher.com/jobs/1bc53e0f6297d570b10d3586","title":"Sr. CSV Engineer","description":"Job Summary\n\nSeeking a Sr. CSV Engineer with 10+ years of experience in pharmaceutical compliance, Computerized System Validation (CSV), and GxP-regulated environments.\n\nThe ideal candidate should have expertise in compliance regulations including 21 CFR Part 11, GxP, GAMP 5, SOX IT, Quality Management, Document Management, and Change Management.\n\nExperience with testing tools such as Client-ALM, JIRA, X-Ray, Agile methodologies, and exposure to global delivery models is required.\n\nUnderstanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5 and SOX IT.\n\nSubject matter expertise in areas such as Quality Management, Document Management, and Change Management.\n\nEstablish, implement, and monitor quality management requirements to ensure IT projects meet Quality and Regulatory requirements.\n\nKnowledge of various testing tools used throughout the pharmaceutical industry.\n\nMust have global client exposure and experience working in a global delivery model.\n\nExperience with Client-ALM, JIRA, X-Ray, and Agile methodologies.\n\nResponsible for developing, implementing, and managing process validation, primary packaging validation, cleaning validation, and revalidation strategies to meet GxP and quality requirements on time and within budget to ensure compliance with regulatory expectations and SOPs.\n\nEstablish and manage validation plans by aligning, coordinating, and supervising prioritization of activities against business needs.\n\nSet local procedures and templates for validation documentation and validation master plans.\n\nDevelop, achieve approval for, and publish validation schedules.\n\nCreate and maintain the overall board validation plan.\n\nGood communication and stakeholder management skills.\n\nRoles & Responsibilities\n\nUnderstanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5 and SOX IT.\n\nSubject matter expertise in areas such as Quality Management, Document Management, and Change Management.\n\nEstablish, implement, and monitor quality management requirements to ensure IT projects meet Quality and Regulatory requirements.\n\nKnowledge of various testing tools used throughout the pharmaceutical industry.\n\nMust have global client exposure and experience working in a global delivery model.\n\nExperience with Client-ALM, JIRA, X-Ray, and Agile methodologies.\n\nResponsible for developing, implementing, and managing process validation, primary packaging validation, cleaning validation, and revalidation strategies to meet GxP and quality requirements on time and within budget to ensure compliance with regulatory expectations and SOPs.\n\nEstablish and manage validation plans by aligning, coordinating, and supervising prioritization of activities against business needs.\n\nSet local procedures and templates for validation documentation and validation master plans.\n\nDevelop, achieve approval for, and publish validation schedules.\n\nCreate and maintain the overall board validation plan.\n\nGood communication and stakeholder management skills.\n\nExperience\n\n10+ years of experience mandatory.\n\nUnderstanding of Compliance, GxP, and Lab Informatics.\n\nExperience in pharmaceutical, regulated, or GxP environments with Computerized System Validation (CSV).\n\n#J-18808-Ljbffr","company":"Katalyst CRO","rawCompany":"katalyst cro","city":"Wayne","state":"PA","isRemote":false,"isActive":false,"createdAt":"2026-07-16T03:37:22.474Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-9199.02","title":"Compliance Managers","slug":"compliance-managers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-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":"Sr. CSV Engineer","description":"Job Summary\n\nSeeking a Sr. CSV Engineer with 10+ years of experience in pharmaceutical compliance, Computerized System Validation (CSV), and GxP-regulated environments.\n\nThe ideal candidate should have expertise in compliance regulations including 21 CFR Part 11, GxP, GAMP 5, SOX IT, Quality Management, Document Management, and Change Management.\n\nExperience with testing tools such as Client-ALM, JIRA, X-Ray, Agile methodologies, and exposure to global delivery models is required.\n\nUnderstanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5 and SOX IT.\n\nSubject matter expertise in areas such as Quality Management, Document Management, and Change Management.\n\nEstablish, implement, and monitor quality management requirements to ensure IT projects meet Quality and Regulatory requirements.\n\nKnowledge of various testing tools used throughout the pharmaceutical industry.\n\nMust have global client exposure and experience working in a global delivery model.\n\nExperience with Client-ALM, JIRA, X-Ray, and Agile methodologies.\n\nResponsible for developing, implementing, and managing process validation, primary packaging validation, cleaning validation, and revalidation strategies to meet GxP and quality requirements on time and within budget to ensure compliance with regulatory expectations and SOPs.\n\nEstablish and manage validation plans by aligning, coordinating, and supervising prioritization of activities against business needs.\n\nSet local procedures and templates for validation documentation and validation master plans.\n\nDevelop, achieve approval for, and publish validation schedules.\n\nCreate and maintain the overall board validation plan.\n\nGood communication and stakeholder management skills.\n\nRoles & Responsibilities\n\nUnderstanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5 and SOX IT.\n\nSubject matter expertise in areas such as Quality Management, Document Management, and Change Management.\n\nEstablish, implement, and monitor quality management requirements to ensure IT projects meet Quality and Regulatory requirements.\n\nKnowledge of various testing tools used throughout the pharmaceutical industry.\n\nMust have global client exposure and experience working in a global delivery model.\n\nExperience with Client-ALM, JIRA, X-Ray, and Agile methodologies.\n\nResponsible for developing, implementing, and managing process validation, primary packaging validation, cleaning validation, and revalidation strategies to meet GxP and quality requirements on time and within budget to ensure compliance with regulatory expectations and SOPs.\n\nEstablish and manage validation plans by aligning, coordinating, and supervising prioritization of activities against business needs.\n\nSet local procedures and templates for validation documentation and validation master plans.\n\nDevelop, achieve approval for, and publish validation schedules.\n\nCreate and maintain the overall board validation plan.\n\nGood communication and stakeholder management skills.\n\nExperience\n\n10+ years of experience mandatory.\n\nUnderstanding of Compliance, GxP, and Lab Informatics.\n\nExperience in pharmaceutical, regulated, or GxP environments with Computerized System Validation (CSV).\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T03:37:22.474Z","dateModified":"2026-07-16T03:37:22.474Z","hiringOrganization":{"@type":"Organization","name":"Katalyst CRO","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Wayne","addressRegion":"PA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"1bc53e0f6297d570b10d3586"},"url":"https://jobsearcher.com/jobs/1bc53e0f6297d570b10d3586"}}