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CSV Validation Engineer

Nashville, TN, US • Posted 30+ days ago • Updated 4 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 30+ days ago

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