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Senior Analytical Method Validation Specialist

1 month ago

Omaha, Nebraska, United States Validation & Engineering Group Full time
Job Title: Laboratory Method Validation SME

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries, including Pharmaceutical, Animal Health, Biotechnology, Chemical, Food, and Medical Devices.

We are seeking a dedicated individual to work under the highest ethics standards for the following position:

  • Method Validation SME

Job Summary:

The Laboratory Method Validation SME will provide expert technical and regulatory guidance on the development, validation, and optimization of analytical methods in support of a client in the animal health industry. This role will focus on ensuring compliance with FDA and USDA regulations while ensuring the methods are fit for purpose within a Good Laboratory Practice (GLP) environment.

Key Responsibilities:

  • Lead the development, validation, and verification of analytical methods, including assays, potency tests, and other relevant tests required by the animal health industry.
  • Provide regulatory guidance to ensure adherence to FDA and USDA requirements throughout the method validation process.
  • Review and evaluate existing methods for improvement opportunities and ensure they meet current regulatory standards.
  • Prepare validation protocols, reports, and documentation required for regulatory submissions.
  • Ensure laboratory compliance with GLP, FDA, USDA, and other applicable regulations, policies, and guidelines.
  • Collaborate with cross-functional teams, including quality assurance, regulatory affairs, and laboratory personnel, to provide subject matter expertise and ensure project milestones are met.
  • Conduct troubleshooting, risk assessments, and technical evaluations as needed to address method performance issues.
  • Stay up-to-date with changes in relevant regulations, standards, and best practices in method validation.
  • Provide training and mentorship to laboratory staff on method validation procedures and regulatory requirements.

Qualifications:

  • Bachelor's degree in Chemistry, Biology, or a related field (Master's or PhD preferred).
  • Minimum of 5-7 years of experience in method development and validation within a regulated environment, preferably in the animal health, pharmaceutical, or biotech industries.
  • Knowledge of FDA and USDA regulations applicable to analytical method validation.
  • Proven experience with a wide range of analytical techniques, such as HPLC, GC, UV, etc.
  • Strong technical writing and documentation skills, with experience preparing validation protocols and reports for regulatory submissions.
  • Ability to work independently and collaborate effectively with cross-functional teams.