Validation Specialist for Pharmaceutical Processes

6 days ago


Lexington, Kentucky, United States Genezen Full time
Job Description

The role of Validation Specialist is a critical component in the development and implementation of pharmaceutical processes at Genezen. This position requires a highly motivated individual to assist in the completion of all project milestones, ensuring compliance with regulatory requirements.

Responsibilities
  • Protocol Development: Develop, execute, and report on installation, operational, and performance qualification activities under the guidance of the Validation Manager.
  • Qualification Activities: Ensure that all qualification activities are performed in accordance with internal procedures, cGMP industry guidelines, and regulatory requirements.
  • Problem Solving: Investigate and troubleshoot validation-related problems, identifying root causes and implementing corrective actions.
  • Change Controls: Initiate and own validation-related change controls and corrective/preventive actions.
Requirements
  • Education: Bachelor's Degree in Engineering or related field.
  • Experience: 0-8 years of validation experience in the pharmaceutical industry.
  • Skills: Excellent communication and problem-solving skills, ability to work independently, and strong attention to detail.
About Genezen

Genezen is a dynamic company committed to delivering innovative solutions for gene therapy and cell therapy clinical trials. Our team works collaboratively to meet the exacting needs of our clients, providing process development, GMP viral vector production, and cell transduction services.

Salary and Benefits

We offer an estimated $65,000 - $85,000 per year salary, depending on experience, plus a comprehensive benefits package, including paid vacation days, sick time, holidays, 401(k) plan, and share appreciation rights. Additionally, we provide opportunities for professional growth and development in a fast-paced and innovative environment.



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