Validation Expert

5 days ago


Gainesville, Florida, United States Ascend Advanced Therapies Full time
Job Overview

We are seeking a highly skilled Validation Expert to join our team at Ascend Advanced Therapies. This is an excellent opportunity for individuals who want to contribute to the future of gene therapy manufacturing.

About the Role

This role will involve working closely with multiple departments to provide validation support for equipment, computer systems, and critical utilities. The successful candidate will be responsible for ensuring site compliance and validating all necessary activities to maintain equipment and systems in a validated state.

Key Responsibilities
  • Equipment and System Validation: Develop specifications for user requirements, functional requirements, design requirements, trace matrices, validation summary reports, and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, IQ/OQ/PQ execution, cleaning validation, sterilization validation, airflow visualization, and computer system validation.
  • Governance and Compliance: Conduct all work according to governing policies, Validation Master Plans, SOPs, industry standards, and governing regulations / cGMPs.
  • Data Analysis and Problem-Solving: Analyze validation test data to determine whether equipment and systems have met validation acceptance criteria or to assist in the identification of potential root causes of problems.

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