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

Summary

We are seeking an experienced Process Validation Engineer to support process validation, equipment qualification, and manufacturing quality activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), validation documentation, risk assessment, and change control. The candidate will ensure compliance with FDA regulations, ISO 13485 standards, and Quality Management System (QMS) requirements while supporting manufacturing transfers, process improvements, and cross-functional engineering initiatives.

Roles And Responsibilities

• Develop, execute, and maintain process validation protocols and reports in accordance with established quality standards.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and processes.
• Support equipment qualification, process verification, and validation activities in medical device manufacturing.
• Prepare and maintain validation documentation, including protocols, test results, reports, and supporting records.
• Utilize PLM Agile to manage engineering documentation, change orders, and document revisions.
• Coordinate engineering change orders (ECOs), change management activities, and Design/Manufacturing Change Orders (DMCOs), as applicable.
• Ensure compliance with FDA regulations, ISO 13485 standards, and internal Quality Management System (QMS) procedures.
• Conduct risk assessments and Failure Mode and Effects Analysis (FMEA) to identify and mitigate manufacturing and process risks.
• Manage change control activities and assess the impact of process, equipment, material, and manufacturing changes on validated processes.
• Support CAPA investigations, deviation investigations, root cause analysis, and implementation of corrective and preventive actions.
• Develop and maintain validation plans, risk assessments, and other quality and engineering documentation.
• Support manufacturing transfer projects, including process transfer, validation planning, and production readiness activities.
• Collaborate with Quality Assurance, Manufacturing Engineering, Research and Development, and other cross-functional teams to resolve validation and manufacturing issues.
• Identify opportunities for continuous improvement in manufacturing processes, equipment performance, and validation systems.
• Ensure validation activities are completed on schedule and comply with applicable regulatory and company requirements.

Education & Experience

• A master's degree in Engineering or a related field is preferred but not required.
• 3-5+ years of experience in process validation, equipment qualification, or manufacturing engineering, preferably 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.
• Exposure to manufacturing transfer projects, process improvements, and production support activities.
• Strong technical writing, analytical, problem-solving, and cross-functional communication skills.