{"schemaVersion":"jobsearcher.job.v1","id":"f0c8b37e8c1357f07dbd16df","url":"https://jobsearcher.com/jobs/f0c8b37e8c1357f07dbd16df","canonicalUrl":"https://jobsearcher.com/jobs/f0c8b37e8c1357f07dbd16df","title":"Process Validation Scientist","description":"Job Title:Process Validation Scientist\r\nLocation:Bloomington, IN\r\nDuration:06-Month\r\nPosition Overview:\r\nWe are seeking an experienced Process Validation Scientist to support process validation, technology transfer, and Process Performance Qualification (PPQ) activities within a pharmaceutical manufacturing environment. The ideal candidate will bring strong hands-on experience in oral solid dosage (OSD) manufacturing, specifically tablets and capsules, with deep knowledge of validation lifecycle activities in a GMP-regulated setting.\r\nKey Responsibilities:\r\nLead and support technology transfer (Tech Transfer) activities between manufacturing sites and internal teams\r\nExecute process validation protocols, including Process Performance Qualification (PPQ) and confirmatory validation runs\r\nReview, analyze, and interpret process performance data to evaluate product quality and process consistency\r\nIdentify, troubleshoot, and resolve process-related issues during validation and commercial manufacturing activities\r\nAuthor, review, and approve validation documentation, protocols, reports, and related GMP documents\r\nSupport process monitoring and continuous improvement initiatives to enhance manufacturing efficiency and compliance\r\nPartner with cross-functional teams including Manufacturing, Quality, MS&T, and Engineering to support validation and process optimization\r\nEnsure compliance with GMP requirements, internal quality standards, and regulatory expectations\r\nRequired Qualifications:\r\nBachelor’s or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline\r\n5–8 years of experience in pharmaceutical manufacturing or process development\r\nMinimum 3+ years of hands-on experience in process validation\r\nStrong experience in oral solid dosage (OSD) manufacturing (tablets and capsules)\r\nHands-on experience with PPQ execution, validation protocols, and process data analysis\r\nStrong understanding of GMP regulations and validation lifecycle principles\r\nPreferred Qualifications:\r\nExperience with manufacturing site-to-site or scale-up technology transfer\r\nStrong troubleshooting and root cause analysis skills\r\nExperience in process optimization and continuous improvement initiatives\r\nFamiliarity with validation documentation and regulatory inspection readiness","company":"Intellectt","rawCompany":"intellectt","city":"Bloomington","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-05-10T01:30:50.178Z","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":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Validation Scientist","description":"Job Title:Process Validation Scientist\r\nLocation:Bloomington, IN\r\nDuration:06-Month\r\nPosition Overview:\r\nWe are seeking an experienced Process Validation Scientist to support process validation, technology transfer, and Process Performance Qualification (PPQ) activities within a pharmaceutical manufacturing environment. The ideal candidate will bring strong hands-on experience in oral solid dosage (OSD) manufacturing, specifically tablets and capsules, with deep knowledge of validation lifecycle activities in a GMP-regulated setting.\r\nKey Responsibilities:\r\nLead and support technology transfer (Tech Transfer) activities between manufacturing sites and internal teams\r\nExecute process validation protocols, including Process Performance Qualification (PPQ) and confirmatory validation runs\r\nReview, analyze, and interpret process performance data to evaluate product quality and process consistency\r\nIdentify, troubleshoot, and resolve process-related issues during validation and commercial manufacturing activities\r\nAuthor, review, and approve validation documentation, protocols, reports, and related GMP documents\r\nSupport process monitoring and continuous improvement initiatives to enhance manufacturing efficiency and compliance\r\nPartner with cross-functional teams including Manufacturing, Quality, MS&T, and Engineering to support validation and process optimization\r\nEnsure compliance with GMP requirements, internal quality standards, and regulatory expectations\r\nRequired Qualifications:\r\nBachelor’s or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline\r\n5–8 years of experience in pharmaceutical manufacturing or process development\r\nMinimum 3+ years of hands-on experience in process validation\r\nStrong experience in oral solid dosage (OSD) manufacturing (tablets and capsules)\r\nHands-on experience with PPQ execution, validation protocols, and process data analysis\r\nStrong understanding of GMP regulations and validation lifecycle principles\r\nPreferred Qualifications:\r\nExperience with manufacturing site-to-site or scale-up technology transfer\r\nStrong troubleshooting and root cause analysis skills\r\nExperience in process optimization and continuous improvement initiatives\r\nFamiliarity with validation documentation and regulatory inspection readiness","datePosted":"2026-05-10T01:30:50.178Z","dateModified":"2026-05-10T01:30:50.178Z","hiringOrganization":{"@type":"Organization","name":"Intellectt","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bloomington","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f0c8b37e8c1357f07dbd16df"},"url":"https://jobsearcher.com/jobs/f0c8b37e8c1357f07dbd16df"}}