CSV Validation Engineer

Katalyst CRO; Nashville (TN); On-site; USD 80,000 - 105,000; Full time

Job summary

Katalyst CRO in Nashville, TN seeks an engineer to support equipment and process validation within a GMP-regulated environment, ensuring FDA and Food/Consumer standards are met.

You will develop, execute, and report IQ/OQ/PQ protocols, perform validation activities (e.g., mixing, packaging), conduct risk assessments, and support CAPA and revalidation, collaborating across functions and guiding validation teams.

Qualifications

• Bachelor's degree in engineering, Manufacturing, Life Sciences, or related field.
• 37 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.

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.

Skills

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Quality assurance

Validation lifecycle

Education

Bachelor's degree in Engineering, Manufacturing, Life Sciences, or related field

Tools

MES

ERP systems

Job description

• 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.
• 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.

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.
• 37 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.