Department : Field - USA Location : Omaha, NE
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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 :
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.START YOUR APPLICATION
