{"schemaVersion":"jobsearcher.job.v1","id":"eadbea3fced8e9865efc9f0c","url":"https://jobsearcher.com/jobs/eadbea3fced8e9865efc9f0c","canonicalUrl":"https://jobsearcher.com/jobs/eadbea3fced8e9865efc9f0c","title":"Validation Engineer","description":"Job SummaryWe are seeking a highly skilled and detail-oriented Validation Engineer for a 12-month contract role located at our pharmaceutical manufacturing facility in Melrose Park, IL. This position requires working the night shift (10:00 PM to 6:00 AM).The ideal candidate will possess robust expertise in technical writing, Standard Operating Procedures (SOPs), and the authoring/execution of rigorous Test Protocols (IQ/OQ/PQ). Experience within a regulated cGMP pharmaceutical environment is mandatory. Exposure to Manufacturing Execution Systems (MES), specifically Werum/Körber PAS-X, is highly preferred.Key ResponsibilitiesProtocol Development & Execution: Draft, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test protocols for pharmaceutical manufacturing equipment, utilities, and automated systems.Technical Writing: Author clear, detailed, and highly compliant validation summary reports, deviations, and data analysis summaries in strict accordance with FDA regulations and 21 CFR Part 11.SOP Maintenance: Create, revise, and update Standard Operating Procedures (SOPs) to ensure production activities align seamlessly with current validation standards and regulatory policies.MES/PAS-X Alignment: Coordinate validation deliverables with the site’s Manufacturing Execution System (MES), leveraging any existing exposure to Werum PAS-X to support Electronic Batch Record (EBR) validation activities and system updates.Deviation & CAPA Investigation: Identify, investigate, and document validation protocol deviations and non-conformances occurring during the night shift, conducting root cause analysis and implementing Corrective and Preventive Actions (CAPAs).Cross-Functional Collaboration: Partner closely with overnight Operations, Manufacturing, Quality Assurance, and Engineering teams to ensure testing schedules minimize disruption to live production windows.Required QualificationsEducation: Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a closely related technical field.Experience: 3+ years of experience performing equipment, process, or computerized system validation within a regulated pharmaceutical or biopharmaceutical environment.Documentation Mastery: Proven excellence in technical writing with a strong track record of authoring flawless test protocols, validation summaries, and standard operating procedures (SOPs).Regulatory Knowledge: Sound understanding of cGMP regulations, GAMP5 guidelines, and data integrity principles.Availability: Must be fully committed and flexible to consistently work the designated night shift schedule (10:00 PM to 6:00 AM).Preferred / Nice-to-Have QualificationsFamiliarity or slight exposure to Werum/Körber PAS-X MES software.Direct experience handling validation changes involving Electronic Batch Records (EBR) or recipe workflows.","company":"Valserv","rawCompany":"valserv","city":"Chicago","state":"IL","isRemote":false,"isActive":false,"createdAt":"2026-10-26T03:54:25.448Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"Job SummaryWe are seeking a highly skilled and detail-oriented Validation Engineer for a 12-month contract role located at our pharmaceutical manufacturing facility in Melrose Park, IL. This position requires working the night shift (10:00 PM to 6:00 AM).The ideal candidate will possess robust expertise in technical writing, Standard Operating Procedures (SOPs), and the authoring/execution of rigorous Test Protocols (IQ/OQ/PQ). Experience within a regulated cGMP pharmaceutical environment is mandatory. Exposure to Manufacturing Execution Systems (MES), specifically Werum/Körber PAS-X, is highly preferred.Key ResponsibilitiesProtocol Development & Execution: Draft, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test protocols for pharmaceutical manufacturing equipment, utilities, and automated systems.Technical Writing: Author clear, detailed, and highly compliant validation summary reports, deviations, and data analysis summaries in strict accordance with FDA regulations and 21 CFR Part 11.SOP Maintenance: Create, revise, and update Standard Operating Procedures (SOPs) to ensure production activities align seamlessly with current validation standards and regulatory policies.MES/PAS-X Alignment: Coordinate validation deliverables with the site’s Manufacturing Execution System (MES), leveraging any existing exposure to Werum PAS-X to support Electronic Batch Record (EBR) validation activities and system updates.Deviation & CAPA Investigation: Identify, investigate, and document validation protocol deviations and non-conformances occurring during the night shift, conducting root cause analysis and implementing Corrective and Preventive Actions (CAPAs).Cross-Functional Collaboration: Partner closely with overnight Operations, Manufacturing, Quality Assurance, and Engineering teams to ensure testing schedules minimize disruption to live production windows.Required QualificationsEducation: Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a closely related technical field.Experience: 3+ years of experience performing equipment, process, or computerized system validation within a regulated pharmaceutical or biopharmaceutical environment.Documentation Mastery: Proven excellence in technical writing with a strong track record of authoring flawless test protocols, validation summaries, and standard operating procedures (SOPs).Regulatory Knowledge: Sound understanding of cGMP regulations, GAMP5 guidelines, and data integrity principles.Availability: Must be fully committed and flexible to consistently work the designated night shift schedule (10:00 PM to 6:00 AM).Preferred / Nice-to-Have QualificationsFamiliarity or slight exposure to Werum/Körber PAS-X MES software.Direct experience handling validation changes involving Electronic Batch Records (EBR) or recipe workflows.","datePosted":"2026-10-26T03:54:25.448Z","dateModified":"2026-10-26T03:54:25.448Z","hiringOrganization":{"@type":"Organization","name":"Valserv","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Chicago","addressRegion":"IL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"eadbea3fced8e9865efc9f0c"},"url":"https://jobsearcher.com/jobs/eadbea3fced8e9865efc9f0c"}}