Method Validation Engineer

Overview

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.

• 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.

• 3-7+ 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 Q2 validation requirements: accuracy, precision, linearity, specificity, robustness, LOQ/LOD, etc.

Location:

Denver, CO, United States