Sr Process Validation

Responsibilities

• Lead remediation and validation activities for global service centers to ensure audit and compliance readiness.
• Develop, execute, and review IQ/OQ/PQ and process verification protocols for manufacturing and service equipment.
• Ensure equipment calibration, maintenance, and documentation are current and compliant.
• Review and update validation documentation, SOPs, work instructions, and quality records.
• Support approved supplier list updates and supplier-related documentation changes as needed.
• Manage engineering change requests, documentation updates, and PLM activities within Windchill.
• Cook up cross-functional efforts across Quality, Operations, Manufacturing Engineering, and Supply Chain teams.
• Provide project leadership and oversight to drive timelines, deliverables, and compliance objectives.
• Support internal and external audits, including preparation and remediation activities.
• Travel periodically to service centers in Latin America and Asia to support onsite assessments and implementation activities.

Requirements

Strong experience in medical device process validation, equipment qualification, quality systems documentation, and cross-functional project leadership.

Skills

A background in Project Management is preferred.