Senior Validation Specialist

5 days ago


Durham, North Carolina, United States Technical Source Full time
Job Overview

We are seeking a highly skilled Validation Engineer III to join our team at Technical Source. This role is ideal for a motivated professional who wants to take on new challenges and make a meaningful impact in a GMP environment.

About the Job

Salary: $120,000 - $150,000 per year, depending on experience. The successful candidate will be responsible for troubleshooting facility issues, developing and executing validation protocols (IQ/OQ/PQ), and leading small capital projects with minimal supervision.

Key Responsibilities
  • Troubleshoot and resolve facility-related issues to ensure seamless operations.
  • Develop and execute comprehensive validation protocols to guarantee equipment and system reliability.
  • Lead cross-functional teams to drive the commissioning, qualification, and validation of new equipment and systems.
  • Maintain accurate and up-to-date standards, drawings, and compliance documents.
  • Author and implement deviations, CAPAs, and change controls in accordance with GMP regulations.
Requirements
  • Bachelor's degree in Engineering with a minimum of 2 years of relevant experience.
  • Familiarity with FDA GMP/EMA regulations and industry best practices.
  • Proficiency in MS Office tools, including Excel, Word, and PowerPoint.
  • Proven experience in validation with plant utilities and a strong understanding of CQV principles.
Benefits

At Technical Source, we offer a competitive salary package, excellent benefits, and opportunities for career growth and development. If you are a motivated and results-driven individual looking for a new challenge, please submit your application.



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