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 <788> )-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 <788> 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:

• 3-7 years of hands-on experience in analytical method development and validation within a GMP-regulated environment.
• Hands-on experience with USP <788> 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.

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