{"schemaVersion":"jobsearcher.job.v1","id":"c10bbf3a737bc159b91bfa18","url":"https://jobsearcher.com/jobs/c10bbf3a737bc159b91bfa18","canonicalUrl":"https://jobsearcher.com/jobs/c10bbf3a737bc159b91bfa18","title":"Validation Engineer 2","description":"Validation Engineer 2 – CSV/CQV Specialist Location: 1201 NW Wall Street, Bend, OR 97703\nWork Model: Full-Time, Onsite\nContract Duration: 6–9 Months (Potential for Extension or Full-Time Conversion)\nPay Rate: $70.92–$99.29/hour (W2)\nBenefits: Weekly Pay, Medical, Dental, and Vision Insurance\nPosition Overview Our client is seeking a Contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV organization. This role will focus on the validation of analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with the Instrumentation and CQV teams .\nThe ideal candidate will have strong CSV and CQV experience , preferably within an analytical laboratory or pharmaceutical/biotechnology environment. This position requires someone who can effectively manage competing priorities, produce high-quality validation documentation, and participate in hands‑on qualification and field execution activities.\nOnsite presence in Bend, Oregon is required.\nHiring Manager Priorities Immediate need due to a significant CQV validation backlog .\nStrong preference for candidates with analytical laboratory experience .\nCandidates with both CSV and CQV experience are highly preferred.\nMust be comfortable balancing priorities between CQV and Instrumentation teams .\nMust be willing to work onsite in Bend to support instrument qualification and field execution activities.\nPrevious experience with backlog remediation or high-volume validation activities is highly desirable.\n\nKey Responsibilities Develop, execute, review, and maintain validation lifecycle documentation, including: Risk Assessments\nUser Requirements Specifications (URS)\nDesign Specifications\nTraceability Matrices\nTest Scripts\nValidation Protocols\nDiscrepancies and Deviations\nSummary Reports\nPeriodic Review Documentation\nSystem Retirement Documentation\n\nSupport qualification and validation activities for new and existing analytical laboratory instruments, computerized systems, and GMP equipment.\nExecute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.\nEnsure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and EU Annex 11 requirements.\nPartner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners to plan and execute validation activities.\nPrepare and support change controls, impact assessments, deviations, CAPAs, and validation protocols related to GMP equipment, analytical instruments, and computerized systems.\nUtilize the Kneat validation platform for document creation, workflow routing, approvals, and record closure.\nAssist with Kneat template development and continuous improvement initiatives.\nMaintain inspection‑ready documentation in accordance with SOPs, GxP requirements, and site procedures.\nMonitor field execution activities, identify gaps, drive discrepancy resolution, and elevate issues as needed.\nProvide support to the Instrumentation team for CSV activities and the CQV team for qualification execution, documentation updates, and readiness activities.\nTravel between Bend campus buildings as needed to support laboratory instrument and equipment qualification.\nPerform other duties as assigned.\n\nRequired Qualifications\nEducation Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.\nExperience 3–5+ years of CQV and/or CSV experience within pharmaceutical, biotechnology, medical device, or another regulated industry.\nExperience supporting qualification of analytical laboratory instruments and equipment .\nExperience working in a cGMP-regulated environment .\nExperience with computerized systems validation and equipment qualification.\nExperience managing multiple validation projects and competing priorities.\nExperience supporting validation backlogs or high-volume validation activities is highly desirable.\n\nTechnical Knowledge Hands‑on experience with Kneat validation/documentation software .\nStrong understanding of GMP documentation requirements and validation practices.\nKnowledge of: GxP regulations\n21 CFR Part 11\n21 CFR Parts 210 and 211\nEU Annex 11\nAnnex 15\nUSP and ASTM standards\n\nUnderstanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.\nStrong understanding of the differences between equipment qualification and instrument/computerized system validation .\n\nKey Competencies Excellent technical writing and documentation skills.\nStrong organizational skills and attention to detail.\nAbility to prioritize multiple projects and stakeholder requirements.\nStrong analytical and problem‑solving skills.\nAbility to work independently and collaboratively in a regulated environment.\nStrong communication and cross‑functional collaboration skills.\nCommitment to quality, compliance, and data integrity.\nAbility to work effectively in a fast‑paced environment with a significant validation backlog.\n\nPhysical & Environmental Requirements Work within a clean, secure, and regulated GMP environment.\nFollow all required site safety procedures and wear appropriate PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.\nAbility to occasionally lift up to 50 pounds .\nAbility to travel between site buildings as needed.\nFlexibility to support project and field execution activities.\n\nIdeal Candidate Profile\nThe strongest candidate will be an experienced CSV/CQV professional with analytical laboratory instrument qualification experience , strong GMP documentation skills, and hands‑on experience executing IQ/OQ/PQ activities. Candidates who have worked with Kneat , supported validation backlogs, and can effectively balance CSV responsibilities with CQV execution will be highly competitive.\n#TMCA\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Sunriver","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-23T03:18:11.098Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-3028.00","title":"Calibration Technologists and Technicians","slug":"calibration-technologists-and-technicians"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"334513","title":"Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables","slug":"instruments-and-related-products-manufacturing-for-measuring-displaying-and-controlling-industrial-process-variables"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer 2","description":"Validation Engineer 2 – CSV/CQV Specialist Location: 1201 NW Wall Street, Bend, OR 97703\nWork Model: Full-Time, Onsite\nContract Duration: 6–9 Months (Potential for Extension or Full-Time Conversion)\nPay Rate: $70.92–$99.29/hour (W2)\nBenefits: Weekly Pay, Medical, Dental, and Vision Insurance\nPosition Overview Our client is seeking a Contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV organization. This role will focus on the validation of analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with the Instrumentation and CQV teams .\nThe ideal candidate will have strong CSV and CQV experience , preferably within an analytical laboratory or pharmaceutical/biotechnology environment. This position requires someone who can effectively manage competing priorities, produce high-quality validation documentation, and participate in hands‑on qualification and field execution activities.\nOnsite presence in Bend, Oregon is required.\nHiring Manager Priorities Immediate need due to a significant CQV validation backlog .\nStrong preference for candidates with analytical laboratory experience .\nCandidates with both CSV and CQV experience are highly preferred.\nMust be comfortable balancing priorities between CQV and Instrumentation teams .\nMust be willing to work onsite in Bend to support instrument qualification and field execution activities.\nPrevious experience with backlog remediation or high-volume validation activities is highly desirable.\n\nKey Responsibilities Develop, execute, review, and maintain validation lifecycle documentation, including: Risk Assessments\nUser Requirements Specifications (URS)\nDesign Specifications\nTraceability Matrices\nTest Scripts\nValidation Protocols\nDiscrepancies and Deviations\nSummary Reports\nPeriodic Review Documentation\nSystem Retirement Documentation\n\nSupport qualification and validation activities for new and existing analytical laboratory instruments, computerized systems, and GMP equipment.\nExecute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.\nEnsure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and EU Annex 11 requirements.\nPartner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners to plan and execute validation activities.\nPrepare and support change controls, impact assessments, deviations, CAPAs, and validation protocols related to GMP equipment, analytical instruments, and computerized systems.\nUtilize the Kneat validation platform for document creation, workflow routing, approvals, and record closure.\nAssist with Kneat template development and continuous improvement initiatives.\nMaintain inspection‑ready documentation in accordance with SOPs, GxP requirements, and site procedures.\nMonitor field execution activities, identify gaps, drive discrepancy resolution, and elevate issues as needed.\nProvide support to the Instrumentation team for CSV activities and the CQV team for qualification execution, documentation updates, and readiness activities.\nTravel between Bend campus buildings as needed to support laboratory instrument and equipment qualification.\nPerform other duties as assigned.\n\nRequired Qualifications\nEducation Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.\nExperience 3–5+ years of CQV and/or CSV experience within pharmaceutical, biotechnology, medical device, or another regulated industry.\nExperience supporting qualification of analytical laboratory instruments and equipment .\nExperience working in a cGMP-regulated environment .\nExperience with computerized systems validation and equipment qualification.\nExperience managing multiple validation projects and competing priorities.\nExperience supporting validation backlogs or high-volume validation activities is highly desirable.\n\nTechnical Knowledge Hands‑on experience with Kneat validation/documentation software .\nStrong understanding of GMP documentation requirements and validation practices.\nKnowledge of: GxP regulations\n21 CFR Part 11\n21 CFR Parts 210 and 211\nEU Annex 11\nAnnex 15\nUSP and ASTM standards\n\nUnderstanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.\nStrong understanding of the differences between equipment qualification and instrument/computerized system validation .\n\nKey Competencies Excellent technical writing and documentation skills.\nStrong organizational skills and attention to detail.\nAbility to prioritize multiple projects and stakeholder requirements.\nStrong analytical and problem‑solving skills.\nAbility to work independently and collaboratively in a regulated environment.\nStrong communication and cross‑functional collaboration skills.\nCommitment to quality, compliance, and data integrity.\nAbility to work effectively in a fast‑paced environment with a significant validation backlog.\n\nPhysical & Environmental Requirements Work within a clean, secure, and regulated GMP environment.\nFollow all required site safety procedures and wear appropriate PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.\nAbility to occasionally lift up to 50 pounds .\nAbility to travel between site buildings as needed.\nFlexibility to support project and field execution activities.\n\nIdeal Candidate Profile\nThe strongest candidate will be an experienced CSV/CQV professional with analytical laboratory instrument qualification experience , strong GMP documentation skills, and hands‑on experience executing IQ/OQ/PQ activities. Candidates who have worked with Kneat , supported validation backlogs, and can effectively balance CSV responsibilities with CQV execution will be highly competitive.\n#TMCA\n#J-18808-Ljbffr","datePosted":"2026-08-23T03:18:11.098Z","dateModified":"2026-08-23T03:18:11.098Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Sunriver","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"c10bbf3a737bc159b91bfa18"},"url":"https://jobsearcher.com/jobs/c10bbf3a737bc159b91bfa18"}}