Global Medical Device Process Validation Lead

Katalyst CRO; Aurora (CO); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is helping a large medical device manufacturer by seeking a Senior Process Validation Engineer to lead validation and documentation efforts across multiple service locations to ensure audit readiness and regulatory compliance.

The role requires collaboration with Quality, Manufacturing, Service, Regulatory, and Supplier teams worldwide, and a background in Project Management is preferred. Travel to service centers in LATAM and Asia is expected.

Qualifications

• Experience in medical device process validation and equipment qualification.
• Ability to document and maintain quality systems and records.
• Strong cross-functional project leadership and collaboration.

Responsibilities

• Lead remediation and validation activities for global service centers.
• Develop, execute, and review IQ/OQ/PQ and process verification protocols.
• Ensure calibration, maintenance, and QA documentation are current.
• Update validation docs, SOPs, and quality records as needed.
• Support supplier documentation changes and changes to the approved list.
• Manage engineering change requests and PLM activities within Windchill.
• Coordinate with Quality, Operations, Manufacturing Eng., and Supply Chain.
• Provide project leadership to meet timelines and compliance objectives.
• Support internal and external audits and remediation activities.
• Travel periodically to service centers in Latin America and Asia.

Skills

Process validation

Equipment qualification

Quality systems documentation

Cross-functional leadership

Project management

Tools

Windchill

Job description

Katalyst CRO is helping a large medical device manufacturer by seeking a Senior Process Validation Engineer to lead validation and documentation efforts across multiple service locations to ensure audit readiness and regulatory compliance.

The role requires collaboration with Quality, Manufacturing, Service, Regulatory, and Supplier teams worldwide, and a background in Project Management is preferred. Travel to service centers in LATAM and Asia is expected.