Senior Medical Device Process Validation Engineer

Katalyst CRO; Norfolk (NE); On-site; USD 75,000 - 115,000; Full time

Job summary

Katalyst CRO is seeking an experienced Process Validation Engineer to support process validation, equipment qualification, and manufacturing quality activities within a medical device environment in Nebraska. You will ensure FDA and ISO 13485 compliance while supporting transfers and process improvements.

Responsibilities include developing IQ/OQ/PQ protocols, maintaining validation documentation, and utilizing PLM Agile for change orders.

Qualifications

• Master's degree preferred but not required.
• 3–5+ years of experience in process validation or manufacturing engineering/manufacturing quality in the medical device industry.
• Hands-on experience developing and executing IQ, OQ, and PQ protocols.
• Experience with PLM Agile, engineering change orders, and DMCO processes.
• Working knowledge of FDA regulations, ISO 13485, and Quality Management Systems.
• Experience with risk assessment methodologies, including FMEA.
• Experience in validation documentation, change control, CAPA, deviation investigations, and root cause analysis.

Responsibilities

• Develop, execute, and maintain process validation protocols and reports.
• Perform IQ/OQ/PQ for manufacturing equipment and processes.
• Support equipment qualification, process verification, and validation activities.
• Prepare and maintain validation documentation including protocols, test results, and reports.
• Utilize PLM Agile to manage documentation, change orders, and revisions.
• Coordinate ECOs, DMCOs, and change management activities.
• Ensure compliance with FDA, ISO 13485, and QMS procedures.
• Conduct risk assessments and FMEA to mitigate risks.
• Manage change control and assess impact of changes on validated processes.
• Support CAPA investigations, deviation investigations, and root cause analysis.
• Develop and maintain validation plans and other quality documentation.
• Support manufacturing transfer projects and production readiness.

Skills

Process validation

Equipment qualification

Risk assessment

FMEA

CAPA

Change control

Root cause analysis

Cross-functional collaboration

Technical writing

Quality systems

Education

Master's degree in Engineering or related field

Bachelor's degree acceptable

Job description

Katalyst CRO is seeking an experienced Process Validation Engineer to support process validation, equipment qualification, and manufacturing quality activities within a medical device environment in Nebraska. You will ensure FDA and ISO 13485 compliance while supporting transfers and process improvements.

Responsibilities include developing IQ/OQ/PQ protocols, maintaining validation documentation, and utilizing PLM Agile for change orders.