Process Validation Engineer: IQ/OQ/PQ Expert

Katalyst-Healthcares-; Norfolk (NE); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

Katalyst-Healthcares- seeks an experienced Process Validation Engineer to support process validation, equipment qualification, and QA activities in a medical device environment.

The candidate will ensure FDA and ISO 13485 compliance, quality management processes, and participation in validation documentation, risk assessments, CAPA, and change control as part of manufacturing transfers and process improvements.

Qualifications

• Master's degree preferred but not required.
• 3–5+ years in process validation/equipment qualification/manufacturing engineering, preferably in medical devices.
• Hands-on IQ/OQ/PQ protocol development and execution.
• Experience with risk assessment methods including FMEA.
• Strong technical writing and cross-functional communication skills.

Responsabilités

• Develop, execute, and maintain process validation protocols and reports.
• Perform IQ, OQ, and PQ for equipment and processes.
• Support equipment qualification, process verification, and validation activities.
• Prepare and maintain validation documentation and supporting records.
• Utilize PLM Agile to manage documentation, ECOs and DMCOs.

Connaissances

Process Validation

IQ/OQ/PQ

Regulatory Compliance

FMEA/Risk Assessment

Technical Writing

Formation

M.S. in Engineering or related field

B.S. in Engineering

Outils

PLM Agile

Description du poste

Katalyst-Healthcares- seeks an experienced Process Validation Engineer to support process validation, equipment qualification, and QA activities in a medical device environment.

The candidate will ensure FDA and ISO 13485 compliance, quality management processes, and participation in validation documentation, risk assessments, CAPA, and change control as part of manufacturing transfers and process improvements.