Demo

Validation Engineer

Katalyst Healthcares and Life Sciences
Nashville, TN Full Time
POSTED ON 3/5/2025
AVAILABLE BEFORE 6/2/2025

Responsibilities :

  • Ensure all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes :
  • These confirm proper functionality and adherence to operational specifications.
  • Validate manufacturing processes (e.g., blending, cutting, rolling, and packaging) to ensure consistent production of high-quality products.
  • Conduct revalidation of equipment and processes when changes occur, such as :
  • ssess risks related to equipment, processes, and production areas that could impact product quality, safety, or compliance.
  • Implement corrective and preventive actions (CAPA) to address risks, such as :
  • Write, review, and execute validation protocols for new equipment, systems, or processes, ensuring documentation meets regulatory and internal requirements.
  • rchive validation documentation (e.g., validation reports, test results, and corrective action reports) for audits and regulatory inspections.
  • Document changes in manufacturing processes or equipment and ensure proper validation before implementation.
  • Train production teams on new validated processes, equipment, and compliance with regulatory and quality standards.

Requirements :

  • Bachelor's degree in engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
  • 3-7 years of quality or relevant process experience in a regulatory environment.
  • Strong communication skills for interaction with cross-functional teams, senior management, and external auditors / regulators.
  • Familiarity with Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems is beneficial.
  • Strong understanding of validation methodologies, including IQ / OQ / PQ protocols, risk assessments, and data analysis techniques.
  • In-depth knowledge of FDA and GMP guidelines, as well as Food / Consumer industry regulations.
  • Proven ability to lead and manage onshore and offshore teams.
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