Method Validation Engineer

Denver, CO, US • Posted 60+ days ago • Updated 6 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Pharmaceutics
Regulatory Compliance
Documentation
Bridging
GMP
Testing
HPLC
Analytical Skill
Workflow

Summary

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 14fb2e864ea9cda039a51408869ea0b5
Posted 30+ days ago

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