Process Validation Engineer

Katalyst-Healthcares-; Norfolk (NE); On-site; USD 85,000 - 120,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Process Validation

IQ/OQ/PQ

Regulatory Compliance

FMEA/Risk Assessment

Technical Writing

Education

M.S. in Engineering or related field

B.S. in Engineering

Tools

PLM Agile

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.