GMP/FDA Validation Engineer – IQ/OQ/PQ Specialist

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

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.