Process Validation Scientist

Job Title:Process Validation Scientist Location:Bloomington, IN Duration:06-Month Position 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 teams Execute process validation protocols, including Process Performance Qualification (PPQ) and confirmatory validation runs Review, analyze, and interpret process performance data to evaluate product quality and process consistency Identify, troubleshoot, and resolve process-related issues during validation and commercial manufacturing activities Author, review, and approve validation documentation, protocols, reports, and related GMP documents Support process monitoring and continuous improvement initiatives to enhance manufacturing efficiency and compliance Partner with cross-functional teams including Manufacturing, Quality, MS&T, and Engineering to support validation and process optimization Ensure compliance with GMP requirements, internal quality standards, and regulatory expectations Required Qualifications: Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline 5–8 years of experience in pharmaceutical manufacturing or process development Minimum 3+ years of hands-on experience in process validation Strong experience in oral solid dosage (OSD) manufacturing (tablets and capsules) Hands-on experience with PPQ execution, validation protocols, and process data analysis Strong understanding of GMP regulations and validation lifecycle principles Preferred Qualifications: Experience with manufacturing site-to-site or scale-up technology transfer Strong troubleshooting and root cause analysis skills Experience in process optimization and continuous improvement initiatives Familiarity with validation documentation and regulatory inspection readiness