ATL01-101024 - Method Validation SME (NE)

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Animal Health, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed 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. This support will mostly be provided remotely with periodic on-site work.

Key Responsibilities:

• Lead the development, validation, and verification of analytical methods, including but not limited to 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 (e.g., 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.