Validation Specialist

4 weeks ago


College Station, Texas, United States CPMNA Full time
Job Overview

CPMNA is seeking a highly skilled Validation Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the validation of our facilities, utilities, systems, and equipment meets regulatory requirements.

Key Responsibilities
  • Develop and execute validation protocols for FUSE systems and infrastructure, including validation plans, system impact assessments, and validation final reports.
  • Collaborate with cross-functional teams to plan and organize validation activities, providing status updates and ensuring compliance with regulatory requirements.
  • Work independently to author protocols, execute validation activities, analyze data, and author reports, with minimal guidance from senior validation engineers.
  • Review and provide feedback on FUSE system delivery life cycle (SDLC) deliverables, ensuring adherence to standard operating procedures (SOPs).
  • Update SOPs, forms, templates, documentation, and files as necessary.
  • Perform all job duties in a compliant and ethical manner, adhering to applicable laws, regulations, and industry codes.
Requirements
  • Master's degree with two years of direct experience in validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Bachelor's degree with four years of direct experience in validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
  • Associates degree with six years of direct experience in validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
Preferred Qualifications
  • Engineering or science degree.


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