{"schemaVersion":"jobsearcher.job.v1","id":"4cc1c17316e585d5cf2cfa5b","url":"https://jobsearcher.com/jobs/4cc1c17316e585d5cf2cfa5b","canonicalUrl":"https://jobsearcher.com/jobs/4cc1c17316e585d5cf2cfa5b","title":"Computer System Validation Engineer","description":"Job Details:\nLeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.\nJob Title : Validations Contractor\nDuration : 12 months\nLocations: Durham NC\nPR: $50/hr - $55/hr\nDescriptions:\nThe Validations Contractor – GMP Quality Assurance, reporting to the Director, GMP Quality Assurance, will be responsible for assisting in the management of Quality Management System (QMS) and will strongly support Culture of Quality. This role will assure corporate compliance with applicable GMP national, international, and state regulations. This position will be based at our headquarters facility in RTP, NC with domestic travel (less than 15% of the time) expected.\nJob Responsibilities\nWork alongside department customers on development, implementation, and integration of Equipment and Computer Systems Validation plans for site wide equipment onboarding.\nProvide timely quality support and thorough reviews and approvals of various records including, but not limited to Change Controls; SOPs; analytical method, equipment and computer system qualification and validation plans, protocols, and summary reports; batch records; QC data; non-conformities and Corrective Action/Preventive Action (CAPAs).\nEnsure QA related activities are performed within the associated project timeline. Effectively escalate concerns to area and project management.\nReport on applicable key metrics to drive continuous improvement in compliance.\nParticipate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues. Effectively collaborate in team environment(s) to ensure timely resolution of compliance and process concerns associated with equipment/computer systems validation activities.\nMaintain Quality Systems in support of QMS and GMPs, including:\nReview and approve SOP drafts and revisions.\nProcess change controls.\nSupport equipment and computer system qualification and validation activities and vendor management program.\nCommunicate project status to stakeholders and escalate issues in a timely manner.\nAbout you\nBachelor’s degree in a scientific field.\n5+ years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or Manufacturing.\nSolid understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.\nAbility to author, review, and interpret Standard Operating Procedures (SOPs).\nAbility to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.\nStrong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.\nAbility to manage workload effectively in order to meet project timelines.\nExcellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.\nProficiency in Microsoft Office Suite (Word, Excel, PowerPoint).\nTo know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/\nShould you have any questions, feel free to call me on (415) 868-6741 or send an email on sharif.khan@leadstackinc.com\nJob Type: Contract\nPay: $45.00 - $55.00 per hour\nSchedule:\n8 hour shift\nMonday to Friday\nWork Location: In person","company":"Leadstackincc050607","rawCompany":"leadstackincc050607","city":"Durham","state":"NC","isRemote":false,"isActive":false,"createdAt":"2026-04-12T21:21:08.887Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"561320","title":"Temporary Help Services","slug":"temporary-help-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer System Validation Engineer","description":"Job Details:\nLeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.\nJob Title : Validations Contractor\nDuration : 12 months\nLocations: Durham NC\nPR: $50/hr - $55/hr\nDescriptions:\nThe Validations Contractor – GMP Quality Assurance, reporting to the Director, GMP Quality Assurance, will be responsible for assisting in the management of Quality Management System (QMS) and will strongly support Culture of Quality. This role will assure corporate compliance with applicable GMP national, international, and state regulations. This position will be based at our headquarters facility in RTP, NC with domestic travel (less than 15% of the time) expected.\nJob Responsibilities\nWork alongside department customers on development, implementation, and integration of Equipment and Computer Systems Validation plans for site wide equipment onboarding.\nProvide timely quality support and thorough reviews and approvals of various records including, but not limited to Change Controls; SOPs; analytical method, equipment and computer system qualification and validation plans, protocols, and summary reports; batch records; QC data; non-conformities and Corrective Action/Preventive Action (CAPAs).\nEnsure QA related activities are performed within the associated project timeline. Effectively escalate concerns to area and project management.\nReport on applicable key metrics to drive continuous improvement in compliance.\nParticipate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues. Effectively collaborate in team environment(s) to ensure timely resolution of compliance and process concerns associated with equipment/computer systems validation activities.\nMaintain Quality Systems in support of QMS and GMPs, including:\nReview and approve SOP drafts and revisions.\nProcess change controls.\nSupport equipment and computer system qualification and validation activities and vendor management program.\nCommunicate project status to stakeholders and escalate issues in a timely manner.\nAbout you\nBachelor’s degree in a scientific field.\n5+ years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or Manufacturing.\nSolid understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.\nAbility to author, review, and interpret Standard Operating Procedures (SOPs).\nAbility to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.\nStrong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.\nAbility to manage workload effectively in order to meet project timelines.\nExcellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.\nProficiency in Microsoft Office Suite (Word, Excel, PowerPoint).\nTo know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/\nShould you have any questions, feel free to call me on (415) 868-6741 or send an email on sharif.khan@leadstackinc.com\nJob Type: Contract\nPay: $45.00 - $55.00 per hour\nSchedule:\n8 hour shift\nMonday to Friday\nWork Location: In person","datePosted":"2026-04-12T21:21:08.887Z","dateModified":"2026-04-12T21:21:08.887Z","hiringOrganization":{"@type":"Organization","name":"Leadstackincc050607","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Durham","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"4cc1c17316e585d5cf2cfa5b"},"url":"https://jobsearcher.com/jobs/4cc1c17316e585d5cf2cfa5b"}}