{"schemaVersion":"jobsearcher.job.v1","id":"84d7170d8cb3decd804bbb51","url":"https://jobsearcher.com/jobs/84d7170d8cb3decd804bbb51","canonicalUrl":"https://jobsearcher.com/jobs/84d7170d8cb3decd804bbb51","title":"Computerized Systems Validation Specialist","description":"SUMMARY\nThis position is responsible for establishing and maintaining the validated state for software-based computerized systems in use at Bora Pharmaceuticals Inc. according to the Validation Policy for Computerized Systems and in compliance with FDA and other regulatory requirements.\nESSENTIAL FUNCTIONS\nReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.\nEstablish working relationships with business units, IT and QA to provide appropriate support for their computerized systems validation requirements.\nParticipate in the generation of user requirements and facilitate the traceability from user requirement specifications to test scripts.\nSupport execution of test scripts and perform validation reviews.\nPreparation of validation plans test plans, protocols, test scripts, reports, and other validation documentation, as requested.\nProcess computerized systems change control requests.\nAssess validation impact for changes requested in software-based computerized systems.\nEnsure appropriate documentation is maintained to support the status of validated, software-based computerized systems.\nPerform administrative tasks for laboratory systems, including user account maintenance, record archival, troubleshooting, and periodic review.\nDevelop and maintain procedures for laboratory systems administrative functions.\nInvestigate unexpected events, classify Incidents and document their impact.\nEnsure procedures and documentation requirements for change control, qualification and incident handling activities are followed according to approved SOP's.\nAssist in vendor evaluations and audits, as requested.\nAssist in regulatory audits, as requested.\nSupport revision of existing procedures as business needs change.\nMaintain internal tracking logs and supporting documentation to ensure completeness and compliance with SOP's.\nStay current with changing business needs and validation requirements for the software-based computerized systems.\nPerform internal audits on tracking logs and supporting documentation to ensure completeness and compliance with SOP's.\nPerform risk assessments for new systems and upgrades to existing validated systems.\nAssist with Quality Systems (eQMS, eDMS) activities, as needed.\nThe above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.\nEDUCATION, EXPERIENCE and SKILLS\nBachelor’s degree with minimum 4 years’ experience in pharmaceutical or medical device manufacturing validation or computer systems validation.\nAssociate's degree in a technical discipline (i.e. Math, Computer Science, Business) and 7 years' experience in pharmaceutical or medical device manufacturing validation or computer systems validation\nMinimum 2 years pharmaceutical or medical device experience in computerized systems validation.\nOther Knowledge, Skills and Abilities:\nWorking knowledge of ERP systems (SAP preferred), laboratory systems (e.g., Waters Empower, Dassault Systèmes Biovia eLN, PerkinElmer UV WinLab, Metrohm OMNIS), and Veeva QualityDocs electronic document management systems.\nUnderstanding of cGMP and Part 11 regulations and documentation requirements.\nKnowledge of network infrastructures, both physical and virtualized.\nWorking knowledge of SDLC principles.\nUnderstanding of computer programming, (PLC/DCS) preferred.\nAcclimated with Microsoft Office software applications (e.g. Word, Excel, PowerPoint, Access); Ability to read drawings (e.g. wiring/cabling, network architecture).\nBenefits Include:\nWe offer a comprehensive benefits package designed to support our employees’ wellbeing, including:\nCompetitive salary and performance-based incentives\nComprehensive health coverage including medical, dental, and vision insurance\nRetirement savings plans with employer contributions\nPaid time off and flexible work arrangements\nProfessional development opportunities\nEmployee wellness programs and resources\nEmployee Assistance Program and Mental Health Resources\nCompensation Range:\n$74,000.00 - $112,000.00\nAt Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.\nBora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.","company":"Bora Pharmaceuticals","rawCompany":"bora pharmaceuticals","city":"Maple Grove","state":"MN","isRemote":false,"isActive":false,"createdAt":"2026-04-15T03:58:14.583Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"},{"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":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"334111","title":"Electronic Computer Manufacturing","slug":"electronic-computer-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computerized Systems Validation Specialist","description":"SUMMARY\nThis position is responsible for establishing and maintaining the validated state for software-based computerized systems in use at Bora Pharmaceuticals Inc. according to the Validation Policy for Computerized Systems and in compliance with FDA and other regulatory requirements.\nESSENTIAL FUNCTIONS\nReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.\nEstablish working relationships with business units, IT and QA to provide appropriate support for their computerized systems validation requirements.\nParticipate in the generation of user requirements and facilitate the traceability from user requirement specifications to test scripts.\nSupport execution of test scripts and perform validation reviews.\nPreparation of validation plans test plans, protocols, test scripts, reports, and other validation documentation, as requested.\nProcess computerized systems change control requests.\nAssess validation impact for changes requested in software-based computerized systems.\nEnsure appropriate documentation is maintained to support the status of validated, software-based computerized systems.\nPerform administrative tasks for laboratory systems, including user account maintenance, record archival, troubleshooting, and periodic review.\nDevelop and maintain procedures for laboratory systems administrative functions.\nInvestigate unexpected events, classify Incidents and document their impact.\nEnsure procedures and documentation requirements for change control, qualification and incident handling activities are followed according to approved SOP's.\nAssist in vendor evaluations and audits, as requested.\nAssist in regulatory audits, as requested.\nSupport revision of existing procedures as business needs change.\nMaintain internal tracking logs and supporting documentation to ensure completeness and compliance with SOP's.\nStay current with changing business needs and validation requirements for the software-based computerized systems.\nPerform internal audits on tracking logs and supporting documentation to ensure completeness and compliance with SOP's.\nPerform risk assessments for new systems and upgrades to existing validated systems.\nAssist with Quality Systems (eQMS, eDMS) activities, as needed.\nThe above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.\nEDUCATION, EXPERIENCE and SKILLS\nBachelor’s degree with minimum 4 years’ experience in pharmaceutical or medical device manufacturing validation or computer systems validation.\nAssociate's degree in a technical discipline (i.e. Math, Computer Science, Business) and 7 years' experience in pharmaceutical or medical device manufacturing validation or computer systems validation\nMinimum 2 years pharmaceutical or medical device experience in computerized systems validation.\nOther Knowledge, Skills and Abilities:\nWorking knowledge of ERP systems (SAP preferred), laboratory systems (e.g., Waters Empower, Dassault Systèmes Biovia eLN, PerkinElmer UV WinLab, Metrohm OMNIS), and Veeva QualityDocs electronic document management systems.\nUnderstanding of cGMP and Part 11 regulations and documentation requirements.\nKnowledge of network infrastructures, both physical and virtualized.\nWorking knowledge of SDLC principles.\nUnderstanding of computer programming, (PLC/DCS) preferred.\nAcclimated with Microsoft Office software applications (e.g. Word, Excel, PowerPoint, Access); Ability to read drawings (e.g. wiring/cabling, network architecture).\nBenefits Include:\nWe offer a comprehensive benefits package designed to support our employees’ wellbeing, including:\nCompetitive salary and performance-based incentives\nComprehensive health coverage including medical, dental, and vision insurance\nRetirement savings plans with employer contributions\nPaid time off and flexible work arrangements\nProfessional development opportunities\nEmployee wellness programs and resources\nEmployee Assistance Program and Mental Health Resources\nCompensation Range:\n$74,000.00 - $112,000.00\nAt Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.\nBora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.","datePosted":"2026-04-15T03:58:14.583Z","dateModified":"2026-04-15T03:58:14.583Z","hiringOrganization":{"@type":"Organization","name":"Bora Pharmaceuticals","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Maple Grove","addressRegion":"MN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"84d7170d8cb3decd804bbb51"},"url":"https://jobsearcher.com/jobs/84d7170d8cb3decd804bbb51"}}