{"schemaVersion":"jobsearcher.job.v1","id":"4da60f7245c9a6c27dbc59d7","url":"https://jobsearcher.com/jobs/4da60f7245c9a6c27dbc59d7","canonicalUrl":"https://jobsearcher.com/jobs/4da60f7245c9a6c27dbc59d7","title":"Validation Engineer (Computer System Validation)","description":"We are seeking a Validation Engineer to support validation activities within a GMP biotechnology environment. In this role, you will partner closely with IT/OT system owners to manage the full lifecycle of computer systems, including maintenance, validation, documentation, and testing. This is a 12‑month contract based onsite five days a week in Hillsboro, Oregon, offering the opportunity to contribute to critical system reliability and compliance efforts.\n\nResponsibilities\n\nCreate/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT). Systems will fall between Level 2 and 3 of the ISA-95 model.\n\nHelp perform MILE (annual system maintenance) activities for ITOT Systems. For example, create, update, execute, or review installation protocols, test protocols, etc.\n\nOwn Quality Management System records (CAPA, Planned Events, Deviations) and orchestrate completion of activities needed.\n\nPerform system periodic reviews; This entails performing data collection from the deviations database on the past 3 year’s worth of planned and unplanned events, review impact on system’s validated state and draft reports.\n\nSupport System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.\n\nSupport validation activities, generation, approval and execution of validation protocols.\n\nAssist System Owners in system maintenance activities such as Periodic System Audit Trail Review, account audits, etc.\n\nCreating reports for various systems on demand.\n\nWork with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.\n\nSupport on documents management systems (Veeva, Condor).\n\nSupport the team with administrative tasks, such as document formatting, document routing.\n\nQualifications\n\nBachelor of Science or equivalent in computer science, engineering, life sciences, or related field.\n\nMinimum 5 years experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry.\n\nKnowledge of or experience with the following technical areas is preferred: SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, DeltaV, Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring, software development.\n\nGood understanding of the ISA-95 model.\n\nExperience working with Level 2 and Level 3 systems is required.\n\nExperience working with Level 1 systems is a plus.\n\nKnowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles.\n\nGood understanding of system and data integrity risk assessment concepts.\n\n$156,894-$196,123\n\nWhy Choose R&D Partners?\nAs an employee, you have access to a comprehensive benefits package including:\n\nMedical insurance – PPO, HMO & HSA\n\n401k plan\n\nEmployee Assistance Program\n\nLong-term disability\n\nWeekly payroll\n\nOnline timecard approval\n\nR&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.\n\nR&D Partners is an equal-opportunity employer.\n\n#J-18808-Ljbffr","company":"RD Partners","rawCompany":"rd partners","city":"Hillsboro","state":"IL","isRemote":false,"isActive":false,"createdAt":"2026-07-16T03:49:07.292Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"}],"industries":[{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"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"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer (Computer System Validation)","description":"We are seeking a Validation Engineer to support validation activities within a GMP biotechnology environment. In this role, you will partner closely with IT/OT system owners to manage the full lifecycle of computer systems, including maintenance, validation, documentation, and testing. This is a 12‑month contract based onsite five days a week in Hillsboro, Oregon, offering the opportunity to contribute to critical system reliability and compliance efforts.\n\nResponsibilities\n\nCreate/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT). Systems will fall between Level 2 and 3 of the ISA-95 model.\n\nHelp perform MILE (annual system maintenance) activities for ITOT Systems. For example, create, update, execute, or review installation protocols, test protocols, etc.\n\nOwn Quality Management System records (CAPA, Planned Events, Deviations) and orchestrate completion of activities needed.\n\nPerform system periodic reviews; This entails performing data collection from the deviations database on the past 3 year’s worth of planned and unplanned events, review impact on system’s validated state and draft reports.\n\nSupport System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.\n\nSupport validation activities, generation, approval and execution of validation protocols.\n\nAssist System Owners in system maintenance activities such as Periodic System Audit Trail Review, account audits, etc.\n\nCreating reports for various systems on demand.\n\nWork with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.\n\nSupport on documents management systems (Veeva, Condor).\n\nSupport the team with administrative tasks, such as document formatting, document routing.\n\nQualifications\n\nBachelor of Science or equivalent in computer science, engineering, life sciences, or related field.\n\nMinimum 5 years experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry.\n\nKnowledge of or experience with the following technical areas is preferred: SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, DeltaV, Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring, software development.\n\nGood understanding of the ISA-95 model.\n\nExperience working with Level 2 and Level 3 systems is required.\n\nExperience working with Level 1 systems is a plus.\n\nKnowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles.\n\nGood understanding of system and data integrity risk assessment concepts.\n\n$156,894-$196,123\n\nWhy Choose R&D Partners?\nAs an employee, you have access to a comprehensive benefits package including:\n\nMedical insurance – PPO, HMO & HSA\n\n401k plan\n\nEmployee Assistance Program\n\nLong-term disability\n\nWeekly payroll\n\nOnline timecard approval\n\nR&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.\n\nR&D Partners is an equal-opportunity employer.\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T03:49:07.292Z","dateModified":"2026-07-16T03:49:07.292Z","hiringOrganization":{"@type":"Organization","name":"RD Partners","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Hillsboro","addressRegion":"IL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"4da60f7245c9a6c27dbc59d7"},"url":"https://jobsearcher.com/jobs/4da60f7245c9a6c27dbc59d7"}}