{"schemaVersion":"jobsearcher.job.v1","id":"6e3e600749f50733a4ecf1cf","url":"https://jobsearcher.com/jobs/6e3e600749f50733a4ecf1cf","canonicalUrl":"https://jobsearcher.com/jobs/6e3e600749f50733a4ecf1cf","title":"Validation Consultant – Computer System Validation (CSV/CSA)","description":"One of Pine's portfolio companies is a leading consulting firm specializing in ERP, quality management, and manufacturing solutions for life science manufacturers. They implement QAD Adaptive ERP, QAD EQMS, NetSuite, ETQ QMS, and related technologies — helping clients navigate clinical-to-commercial transitions, regulatory compliance, and operational excellence. They're looking for a Validation Consultant to serve as a senior technical authority for computer system validation (CSV) and computer software assurance (CSA) across their life science consulting portfolio.\nThe successful candidate will establish and maintain the firm's validation strategy, extend its validation toolkits across QAD, NetSuite, QAD EQMS, ETQ, and supporting add-on platforms, and lead end-to-end validation delivery on client engagements. This role works alongside the current Validation Practice Lead and is accountable for ensuring every validation package produced is inspection-ready and aligned with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and data integrity expectations.\nThis is a full-time primarily role with approximately 10% travel to client sites, primarily within North America.\nWhat You'll Do\nEstablish and maintain the firm's validation strategy and standards, ensuring all deliverables align with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and ALCOA+ data integrity principles.\nMaintain and continuously improve validation toolkits for QAD ERP, NetSuite, QAD EQMS, and ETQ — including URS/FRS templates, risk assessments, requirements traceability matrices (RTMs), IQ/OQ/PQ scripts, and script libraries.\nMaintain standalone validation toolkits for Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and Eagle RF.\nAnalyze software release specifications and release notes to determine validation impact, risk, and required deliverable updates.\nBuild new validation toolkit frameworks for new software platforms and modules as the service portfolio expands.\nLead end-to-end client validation engagements, including validation planning, protocol authoring, execution support, evidence review, deviation handling, and validation summary reporting (VSR).\nProvide validation guidance and execution support to client teams as embedded staff augmentation.\nInterpret client SOPs and internal CSV/QMS requirements, tailoring deliverables to meet both client-internal and regulatory expectations.\nMentor junior validation consultants and contribute to the firm's Computer Validation as a Service (CVaaS) offering.\nWhat They're Looking For\nRequired\n10+ years of experience in computer system validation (CSV) or computer software assurance (CSA) for life science manufacturers.\nDeep working knowledge of cGxP, GAMP 5 Category 4, 21 CFR Part 11, EU Annex 11, ALCOA+, and CSA principles applied to risk-based validation.\nFamiliarity with 21 CFR Part 820/QMSR and ISO 13485 quality system requirements.\nDemonstrated ability to design and maintain reusable validation toolkits, including URS/FRS templates, RTMs, IQ/OQ/PQ scripts, risk assessments, and validation summary reports.\nStrong release impact analysis skills — able to translate software release specifications into validation scope, risk, and deliverable updates.\nExcellent technical and compliance writing skills, producing audit-ready validation documentation.\nExperience executing or supporting validation protocol execution, including evidence capture, deviation documentation, and results review.\nProven client stakeholder communication skills across QA, IT, and business functions.\nExperience operating as staff augmentation, integrating into client teams and working within client QMS and SDLC constraints.\nBachelor's degree in Engineering, Life Sciences, Computer Science, or a related field; advanced degree a plus.\nNice to Have\nHands-on validation experience with QAD ERP, NetSuite, QAD EQMS, or ETQ.\nHands-on validation experience with QAD add-ons including Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and Eagle RF.\nExperience building net-new validation toolkit frameworks for emerging software offerings.\nExperience supporting CSV/CSA programs for medical device or pharmaceutical manufacturers.\nValidation-related professional certifications (ASQ CQA and/or CQE).\nPrior consulting experience in a continuous release validation process or managed validation services model.\nWhat They Offer\nLocation: Remote (US)\nEmployment Type: Full-Time\nTravel: Approximately 10%, primarily within North America\nBenefits: Competitive benefits package (medical, dental, vision), generous PTO and company-observed holidays, 401(k) with employer match, professional development opportunities, and a people-first culture backed by Pine Services Group\nWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.","company":"Pine Services Group","rawCompany":"pine services group","city":"Remote","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-04T00:14:28.417Z","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":"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":"541618","title":"Other Management Consulting Services","slug":"other-management-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Consultant – Computer System Validation (CSV/CSA)","description":"One of Pine's portfolio companies is a leading consulting firm specializing in ERP, quality management, and manufacturing solutions for life science manufacturers. They implement QAD Adaptive ERP, QAD EQMS, NetSuite, ETQ QMS, and related technologies — helping clients navigate clinical-to-commercial transitions, regulatory compliance, and operational excellence. They're looking for a Validation Consultant to serve as a senior technical authority for computer system validation (CSV) and computer software assurance (CSA) across their life science consulting portfolio.\nThe successful candidate will establish and maintain the firm's validation strategy, extend its validation toolkits across QAD, NetSuite, QAD EQMS, ETQ, and supporting add-on platforms, and lead end-to-end validation delivery on client engagements. This role works alongside the current Validation Practice Lead and is accountable for ensuring every validation package produced is inspection-ready and aligned with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and data integrity expectations.\nThis is a full-time primarily role with approximately 10% travel to client sites, primarily within North America.\nWhat You'll Do\nEstablish and maintain the firm's validation strategy and standards, ensuring all deliverables align with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and ALCOA+ data integrity principles.\nMaintain and continuously improve validation toolkits for QAD ERP, NetSuite, QAD EQMS, and ETQ — including URS/FRS templates, risk assessments, requirements traceability matrices (RTMs), IQ/OQ/PQ scripts, and script libraries.\nMaintain standalone validation toolkits for Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and Eagle RF.\nAnalyze software release specifications and release notes to determine validation impact, risk, and required deliverable updates.\nBuild new validation toolkit frameworks for new software platforms and modules as the service portfolio expands.\nLead end-to-end client validation engagements, including validation planning, protocol authoring, execution support, evidence review, deviation handling, and validation summary reporting (VSR).\nProvide validation guidance and execution support to client teams as embedded staff augmentation.\nInterpret client SOPs and internal CSV/QMS requirements, tailoring deliverables to meet both client-internal and regulatory expectations.\nMentor junior validation consultants and contribute to the firm's Computer Validation as a Service (CVaaS) offering.\nWhat They're Looking For\nRequired\n10+ years of experience in computer system validation (CSV) or computer software assurance (CSA) for life science manufacturers.\nDeep working knowledge of cGxP, GAMP 5 Category 4, 21 CFR Part 11, EU Annex 11, ALCOA+, and CSA principles applied to risk-based validation.\nFamiliarity with 21 CFR Part 820/QMSR and ISO 13485 quality system requirements.\nDemonstrated ability to design and maintain reusable validation toolkits, including URS/FRS templates, RTMs, IQ/OQ/PQ scripts, risk assessments, and validation summary reports.\nStrong release impact analysis skills — able to translate software release specifications into validation scope, risk, and deliverable updates.\nExcellent technical and compliance writing skills, producing audit-ready validation documentation.\nExperience executing or supporting validation protocol execution, including evidence capture, deviation documentation, and results review.\nProven client stakeholder communication skills across QA, IT, and business functions.\nExperience operating as staff augmentation, integrating into client teams and working within client QMS and SDLC constraints.\nBachelor's degree in Engineering, Life Sciences, Computer Science, or a related field; advanced degree a plus.\nNice to Have\nHands-on validation experience with QAD ERP, NetSuite, QAD EQMS, or ETQ.\nHands-on validation experience with QAD add-ons including Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and Eagle RF.\nExperience building net-new validation toolkit frameworks for emerging software offerings.\nExperience supporting CSV/CSA programs for medical device or pharmaceutical manufacturers.\nValidation-related professional certifications (ASQ CQA and/or CQE).\nPrior consulting experience in a continuous release validation process or managed validation services model.\nWhat They Offer\nLocation: Remote (US)\nEmployment Type: Full-Time\nTravel: Approximately 10%, primarily within North America\nBenefits: Competitive benefits package (medical, dental, vision), generous PTO and company-observed holidays, 401(k) with employer match, professional development opportunities, and a people-first culture backed by Pine Services Group\nWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.","datePosted":"2026-08-04T00:14:28.417Z","dateModified":"2026-08-04T00:14:28.417Z","hiringOrganization":{"@type":"Organization","name":"Pine Services Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Remote","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"6e3e600749f50733a4ecf1cf"},"url":"https://jobsearcher.com/jobs/6e3e600749f50733a4ecf1cf"}}