Process Validation Scientist

Job Title: Process Validation ScientistLocation: Bloomington, INDuration: 06-MonthPosition Overview:We 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.Key Responsibilities:Lead and support technology transfer (Tech Transfer) activities between manufacturing sites and internal teamsExecute process validation protocols, including Process Performance Qualification (PPQ) and confirmatory validation runsReview, analyze, and interpret process performance data to evaluate product quality and process consistencyIdentify, troubleshoot, and resolve process-related issues during validation and commercial manufacturing activitiesAuthor, review, and approve validation documentation, protocols, reports, and related GMP documentsSupport process monitoring and continuous improvement initiatives to enhance manufacturing efficiency and compliancePartner with cross-functional teams including Manufacturing, Quality, MS&T, and Engineering to support validation and process optimizationEnsure compliance with GMP requirements, internal quality standards, and regulatory expectationsRequired Qualifications:Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline5–8 years of experience in pharmaceutical manufacturing or process developmentMinimum 3+ years of hands-on experience in process validationStrong experience in oral solid dosage (OSD) manufacturing (tablets and capsules)Hands-on experience with PPQ execution, validation protocols, and process data analysisStrong understanding of GMP regulations and validation lifecycle principlesPreferred Qualifications:Experience with manufacturing site-to-site or scale-up technology transferStrong troubleshooting and root cause analysis skillsExperience in process optimization and continuous improvement initiativesFamiliarity with validation documentation and regulatory inspection readiness