{"schemaVersion":"jobsearcher.job.v1","id":"ff7a2981b69a6dcf4705b71a","url":"https://jobsearcher.com/jobs/ff7a2981b69a6dcf4705b71a","canonicalUrl":"https://jobsearcher.com/jobs/ff7a2981b69a6dcf4705b71a","title":"IT CSV Engineer","description":"Job Title: IT CSV Engineer\nLocation: Remote OR WA based\nReports to: Senior Manager/Group Leader, CSV\nAbout Us:\nAt Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged, it’s celebrated.\n\nAre you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!\n\nThe Role:\nWe’re looking for a passionate and curious IT CSV Engineer to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.\n\nAs an IT CSV Engineer at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.\n\nWhat You'll Do:\n\nLead validation efforts for Manufacturing (MFG), Quality Control (QC), enterprise, and PP&D systems within the Sandoz remediation initiative.\n\nEnsure adherence to client requirements, regulatory compliance, and project timelines.\n\nCollaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations.\n\nDevelop validation strategies and author validation documents such as validation master plans, data migration plans, protocols, reports, and discrepancy resolutions.\n\nManage and optimize validation testing processes, ensuring risk-based validation approaches align with current FDA Computer Software Assurance (CSA) principles and GAMP5 practices.\n\nStandardize and enhance CSV framework templates and procedures to drive continuous improvement initiatives.\n\nSupport and oversee risk management activities, including risk-based assessments and gap remediation efforts.\n\nEnsure compliance and maintain the validated state of all GxP systems.\n\nManage external CSV consultants and oversee their contributions to CSV projects.\n\nServe as a subject matter expert (SME) for Data Integrity, CSV lifecycle management, and compliance with global regulatory expectations.\n\nOwn CSV-related deviations and CAPAs, managing remediation efforts related to CSV and Data Integrity.\n\nPartner with IT to establish backup/restore protocols, disaster recovery strategies, adherence to data retention schedules, and infrastructure qualification requirements.\n\nAssist business and technical owners in developing requirements and specifications for computerized systems used in GxP operations.\n\nOversee the authoring and execution of IQ, OQ, and PQ test scripts.\n\nWho You Are:\n\nStrong experience with GxP computer systems validation and compliance.\n\nIn-depth knowledge of GxP regulations and CSV/CSA principles, including but not limited to 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.\n\nExperience with Quality Risk Management (ICH Q9) and its application in CSV.\n\n5+ years of experience in GxP CSV roles.\n\nThorough understanding of validation/qualification concepts within pharmaceutical quality systems.\n\nStrong technical writing skills for validation documentation and compliance reporting.\n\nExcellent communication skills (both oral and written) with the ability to effectively interact across organizational levels and functions.\n\nWhy Join Us:\n\nGrowth Opportunities : We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.\n\nInclusive Culture : We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.\n\nInnovative Projects : You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.\n\nA Place for Big Ideas : We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.\n\nAre You Still Curious?\nIf you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you and how it will shape the future of Just-Evotec.\n\nLet your curiosity guide your career #BeCurious and explore the endless possibilities at Evotec!\n\nThe base pay range for this position at commencement of employment is expected to be $115,000 to $135,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.\n\nEvotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.\n\n#J-18808-Ljbffr","company":"Evote","rawCompany":"evote","city":"Carnation","state":"WA","isRemote":false,"isActive":true,"createdAt":"2026-06-17T04:22:28.140Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-9199.02","title":"Compliance Managers","slug":"compliance-managers"},{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541511","title":"Custom Computer Programming Services","slug":"custom-computer-programming-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"IT CSV Engineer","description":"Job Title: IT CSV Engineer\nLocation: Remote OR WA based\nReports to: Senior Manager/Group Leader, CSV\nAbout Us:\nAt Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged, it’s celebrated.\n\nAre you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!\n\nThe Role:\nWe’re looking for a passionate and curious IT CSV Engineer to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.\n\nAs an IT CSV Engineer at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.\n\nWhat You'll Do:\n\nLead validation efforts for Manufacturing (MFG), Quality Control (QC), enterprise, and PP&D systems within the Sandoz remediation initiative.\n\nEnsure adherence to client requirements, regulatory compliance, and project timelines.\n\nCollaborate with cross-functional teams to execute complex Computer System Validation (CSV) projects, including remediation and new system implementations.\n\nDevelop validation strategies and author validation documents such as validation master plans, data migration plans, protocols, reports, and discrepancy resolutions.\n\nManage and optimize validation testing processes, ensuring risk-based validation approaches align with current FDA Computer Software Assurance (CSA) principles and GAMP5 practices.\n\nStandardize and enhance CSV framework templates and procedures to drive continuous improvement initiatives.\n\nSupport and oversee risk management activities, including risk-based assessments and gap remediation efforts.\n\nEnsure compliance and maintain the validated state of all GxP systems.\n\nManage external CSV consultants and oversee their contributions to CSV projects.\n\nServe as a subject matter expert (SME) for Data Integrity, CSV lifecycle management, and compliance with global regulatory expectations.\n\nOwn CSV-related deviations and CAPAs, managing remediation efforts related to CSV and Data Integrity.\n\nPartner with IT to establish backup/restore protocols, disaster recovery strategies, adherence to data retention schedules, and infrastructure qualification requirements.\n\nAssist business and technical owners in developing requirements and specifications for computerized systems used in GxP operations.\n\nOversee the authoring and execution of IQ, OQ, and PQ test scripts.\n\nWho You Are:\n\nStrong experience with GxP computer systems validation and compliance.\n\nIn-depth knowledge of GxP regulations and CSV/CSA principles, including but not limited to 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.\n\nExperience with Quality Risk Management (ICH Q9) and its application in CSV.\n\n5+ years of experience in GxP CSV roles.\n\nThorough understanding of validation/qualification concepts within pharmaceutical quality systems.\n\nStrong technical writing skills for validation documentation and compliance reporting.\n\nExcellent communication skills (both oral and written) with the ability to effectively interact across organizational levels and functions.\n\nWhy Join Us:\n\nGrowth Opportunities : We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.\n\nInclusive Culture : We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.\n\nInnovative Projects : You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.\n\nA Place for Big Ideas : We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.\n\nAre You Still Curious?\nIf you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you and how it will shape the future of Just-Evotec.\n\nLet your curiosity guide your career #BeCurious and explore the endless possibilities at Evotec!\n\nThe base pay range for this position at commencement of employment is expected to be $115,000 to $135,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.\n\nEvotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T04:22:28.140Z","dateModified":"2026-06-17T04:22:28.140Z","hiringOrganization":{"@type":"Organization","name":"Evote","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Carnation","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ff7a2981b69a6dcf4705b71a"},"url":"https://jobsearcher.com/jobs/ff7a2981b69a6dcf4705b71a"}}