Test Method Validation Consultant

Test Method Validation Consultant – Analytical Method Development

Location: Bedford, MA

Contract: Initial 6-Month Contract (high likelihood of extension)

Overview

Our client is seeking an experienced Test Method Validation (TMV) Consultant to support a critical analytical laboratory program within a GMP-regulated environment.

The primary focus of the role will be the development, optimization, execution, and validation of analytical test methods used to support cleaning verification activities. The successful consultant will initially support TOC-based analytical methods and will play a key role in establishing and executing the full TMV lifecycle within the laboratory.

While direct experience with Shimadzu TOC analyzers is highly desirable, candidates with strong analytical method development and validation experience across comparable laboratory instrumentation will also be considered.

Key Responsibilities

• Lead analytical Test Method Development and Validation (TMV) activities within a GMP laboratory environment.
• Develop, optimize, troubleshoot, and validate analytical methods used for cleaning verification testing.
• Design and execute method validation studies, including accuracy, precision, robustness, linearity, and method suitability assessments.
• Develop validation protocols, reports, SOPs, and supporting GMP documentation.
• Troubleshoot analytical methods and instrumentation where required.
• Support laboratory efficiency improvements and future analytical method lifecycle activities.

Required Experience

• Proven experience performing Test Method Validation (TMV) within pharmaceutical, biotech, medical device, or other GMP-regulated environments.
• Strong hands-on analytical laboratory background.
• Experience developing, validating, transferring, optimizing, or troubleshooting analytical methods.
• Experience with analytical instrumentation such as TOC analyzers, HPLC, UPLC, GC, IC, UV-Vis, or comparable laboratory systems.
• Strong understanding of validation lifecycle activities and GMP documentation practices.
• Ability to work independently and drive method development and validation activities from planning through execution.

Preferred Experience

• Experience with Shimadzu TOC analyzers.
• Experience supporting TOC analytical methods used within cleaning verification programs.
• Experience operating in GMP QC laboratory environments.
• Previous consultant or project-based validation experience.