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Validation Analyst

3 months ago

Middleton, United States Talent Groups Full time

A Validation Engineer is responsible for ensuring that systems, equipment, and processes meet regulatory requirements and operate as intended. They play a critical role in maintaining the integrity of pharmaceutical products through rigorous testing, analysis, and documentation. The role often involves collaborating with various departments, including manufacturing, quality assurance, and regulatory affairs.

Key Responsibilities:

  • Validation Planning: Develop and implement validation strategies, plans, and protocols for equipment, processes, and systems used in pharmaceutical manufacturing.
  • Protocol Development: Write and review validation protocols (IQ, OQ, PQ) and standard operating procedures (SOPs) to ensure compliance with regulatory standards (e.g., FDA, EMA).
  • Execution and Testing: Conduct validation testing, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for new and existing equipment and systems.
  • Data Analysis: Analyze test results, compile validation reports, and ensure all data meets predefined acceptance criteria.
  • Compliance and Documentation: Ensure all validation activities are documented accurately and maintain comprehensive records to comply with regulatory requirements.
  • Risk Assessment: Perform risk assessments and develop mitigation strategies for potential issues related to equipment and process validation.
  • Continuous Improvement: Identify opportunities for process improvements and contribute to the development and implementation of best practices in validation procedures.
  • Cross-functional Collaboration: Work closely with manufacturing, quality assurance, regulatory affairs, and other departments to support product development and manufacturing processes.
  • Training: Train and mentor junior staff on validation processes, protocols, and best practices.