Method Validation Engineer

Job Description:We are seeking an experienced Method Validation Engineer to support the development, validation, and implementation of analytical methods—primarily dissolution and particulate matter testing (USP )—for a GMP release testing laboratory supporting a pharmaceutical compounding facility. The consultant will work alongside an existing chemist trained in UPLC analysis to ensure methods meet regulatory, quality, and operational requirements for routine release testing. Responsibilities: Analytical Method Development & Validation. Develop, optimize, and validate dissolution methods for various drug products in accordance with USP and ICH guidelines. Perform validation of USP particulate matter testing methods, ensuring compliance with regulatory requirements. Draft, review, and finalize Method Validation Protocols (MVPs) and Method Validation Reports (MVRs). Conduct method transfer activities, including preparing documentation, performing bridging studies, and supporting qualification of instruments used for validation . Qualifications: -+ years of hands-on experience in analytical method development and validation within a GMP-regulated environment. Hands-on experience with USP particulate matter testing (must-have). Strong understanding of UPLC/HPLC analytical workflows (execution may be done by another chemist; knowledge required to integrate method steps). Proficiency with ICH Q validation requirements: accuracy, precision, linearity, specificity, robustness, LOQ/LOD, etc.

Created: 2026-03-12