{"schemaVersion":"jobsearcher.job.v1","id":"2b1e933649c92a14aa7b11ff","url":"https://jobsearcher.com/jobs/2b1e933649c92a14aa7b11ff","canonicalUrl":"https://jobsearcher.com/jobs/2b1e933649c92a14aa7b11ff","title":"Computerized Systems Validation Engineer","description":"TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.\nJob Title: Computerized Systems Validation Engineer\nDuration: 6 Months\nJob Type: Temporary Assignment\nWork Type: Onsite\nPay Range: $30 to $45 - Depends on experience and flexible\nPlease Note: Applicants must be currently authorized to work full-time in the United States for any employer. This role does not offer visa sponsorship, now or in the future, and only W2 candidates will be considered for this position.\nSummary Support qualification and validation activities within the CQV department. This role will provide validation support for analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with the Instrumentation and CQV teams. The successful candidate will split time supporting CQV priorities and Instrumentation team CSV activities, manage multiple priorities simultaneously, produce high-quality documentation, and work hands-on with laboratory instruments and equipment in a regulated cGMP environment. Onsite presence is required.\nResponsibilities Develop, execute, review, and maintain validation lifecycle documentation, including Risk Assessments, User Requirement Specifications (URS), Design Specifications, Traceability Matrices, Test Scripts, Validation Protocols, Discrepancies and Deviations, Summary Reports, Periodic Review Documentation, and System Retirement Documentation.\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 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 and support the Kneat validation platform, including 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 early, drive discrepancy resolution, and elevate issues as appropriate.\nSplit support between the Instrumentation team for CSV activities and the CQV group for qualification execution, documentation updates, and readiness activities.\nTravel between campus buildings as needed to support laboratory instrument and equipment qualification activities.\nPerform other duties as assigned.\nRequired Skills Bachelor's Degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.\nMinimum 3-5 years of CQV and/or CSV experience within pharmaceutical, biotechnology, or other regulated industries.\nExperience supporting analytical laboratory instruments and equipment qualification.\nExperience working in cGMP-regulated environments.\nExperience with computerized systems validation and equipment qualification.\nExperience managing multiple validation projects and competing priorities.\nPrevious backlog remediation or high-volume validation support experience is highly desirable.\nStrong understanding of GMP documentation requirements and validation practices.\nKnowledge of GxP regulations, 21 CFR Part 11, 21 CFR Parts 210 and 211, EU Annex 11, Annex 15, USP and ASTM standards.\nUnderstanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.\nStrong understanding of equipment qualification versus instrument validation requirements.\nExcellent technical writing and documentation skills.\nStrong organization and attention to detail.\nAbility to prioritize effectively across multiple projects and stakeholders.\nProactive problem-solving skills.\nAbility to work both independently and collaboratively in a regulated environment.\nStrong communication and cross-functional collaboration skills.\nCommitment to quality, compliance, and data integrity.\nWork within a clean, secure, and regulated GMP environment.\nWear required PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.\nOccasional lifting of up to 50 pounds.\nTravel between site buildings as needed.\nFlexible schedule to support project activities.\nTekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.\n\n#J-18808-Ljbffr","company":"TekWissen","rawCompany":"tekwissen","city":"Sunriver","state":"OR","isRemote":false,"isActive":false,"createdAt":"2026-08-23T03:13:12.348Z","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":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computerized Systems Validation Engineer","description":"TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.\nJob Title: Computerized Systems Validation Engineer\nDuration: 6 Months\nJob Type: Temporary Assignment\nWork Type: Onsite\nPay Range: $30 to $45 - Depends on experience and flexible\nPlease Note: Applicants must be currently authorized to work full-time in the United States for any employer. This role does not offer visa sponsorship, now or in the future, and only W2 candidates will be considered for this position.\nSummary Support qualification and validation activities within the CQV department. This role will provide validation support for analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with the Instrumentation and CQV teams. The successful candidate will split time supporting CQV priorities and Instrumentation team CSV activities, manage multiple priorities simultaneously, produce high-quality documentation, and work hands-on with laboratory instruments and equipment in a regulated cGMP environment. Onsite presence is required.\nResponsibilities Develop, execute, review, and maintain validation lifecycle documentation, including Risk Assessments, User Requirement Specifications (URS), Design Specifications, Traceability Matrices, Test Scripts, Validation Protocols, Discrepancies and Deviations, Summary Reports, Periodic Review Documentation, and System Retirement Documentation.\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 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 and support the Kneat validation platform, including 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 early, drive discrepancy resolution, and elevate issues as appropriate.\nSplit support between the Instrumentation team for CSV activities and the CQV group for qualification execution, documentation updates, and readiness activities.\nTravel between campus buildings as needed to support laboratory instrument and equipment qualification activities.\nPerform other duties as assigned.\nRequired Skills Bachelor's Degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.\nMinimum 3-5 years of CQV and/or CSV experience within pharmaceutical, biotechnology, or other regulated industries.\nExperience supporting analytical laboratory instruments and equipment qualification.\nExperience working in cGMP-regulated environments.\nExperience with computerized systems validation and equipment qualification.\nExperience managing multiple validation projects and competing priorities.\nPrevious backlog remediation or high-volume validation support experience is highly desirable.\nStrong understanding of GMP documentation requirements and validation practices.\nKnowledge of GxP regulations, 21 CFR Part 11, 21 CFR Parts 210 and 211, EU Annex 11, Annex 15, USP and ASTM standards.\nUnderstanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.\nStrong understanding of equipment qualification versus instrument validation requirements.\nExcellent technical writing and documentation skills.\nStrong organization and attention to detail.\nAbility to prioritize effectively across multiple projects and stakeholders.\nProactive problem-solving skills.\nAbility to work both independently and collaboratively in a regulated environment.\nStrong communication and cross-functional collaboration skills.\nCommitment to quality, compliance, and data integrity.\nWork within a clean, secure, and regulated GMP environment.\nWear required PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.\nOccasional lifting of up to 50 pounds.\nTravel between site buildings as needed.\nFlexible schedule to support project activities.\nTekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.\n\n#J-18808-Ljbffr","datePosted":"2026-08-23T03:13:12.348Z","dateModified":"2026-08-23T03:13:12.348Z","hiringOrganization":{"@type":"Organization","name":"TekWissen","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Sunriver","addressRegion":"OR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"2b1e933649c92a14aa7b11ff"},"url":"https://jobsearcher.com/jobs/2b1e933649c92a14aa7b11ff"}}