CSV Validation Engineer

Nashville, TN, US • Posted 3 hours ago • Updated 3 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Computerized System Validation
  • Reporting
  • Risk Assessment
  • Corrective And Preventive Action
  • Regulatory Compliance
  • Collaboration
  • Team Leadership
  • Manufacturing
  • Life Sciences
  • IQ
  • OQ
  • PQ
  • GMP
  • MES
  • Enterprise Resource Planning
  • Communication

Summary

Job Summary:
  • Responsible for supporting equipment and process validation activities within a regulated environment, ensuring compliance with GMP, FDA, and Food/Consumer industry standards.
  • The role focuses on validation lifecycle execution, risk-based approaches, and cross-functional collaboration to maintain product quality and regulatory compliance.

Roles & Responsibilities:
  • Develop, execute, and report IQ/OQ/PQ protocols.
  • Perform equipment and process validation activities (e.g., mixing, packaging).
  • Conduct risk assessments and support CAPA and revalidation activities.
  • Ensure compliance with GMP, FDA, and Food/Consumer industry regulations.
  • Collaborate cross-functionally with teams and support team leadership activities.

Education & Experience:
  • Bachelor's degree in engineering, Manufacturing, Life Sciences, or related field.
  • 3-7 years of experience in a regulated quality or validation environment.
  • Strong hands-on experience with IQ/OQ/PQ and risk-based validation methodologies.
  • Solid understanding of FDA, GMP, and Food/Consumer industry regulations.
  • Familiarity with MES and ERP systems (an asset).
  • Excellent communication skills and ability to work cross-functionally.
  • Experience leading or coordinating validation teams is a plus.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: c2ee165a4aba7cfe87afd76efcea27ba
  • Posted 3 hours ago
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