Sr. Process Validation

Job Description

Job Description

Job description:

• Our client is seeking a Senior Process Validation Engineer to support a large medical device manufacturer in re-establishing and standardizing global service center operations to ensure audit readiness and regulatory compliance.
• This individual will lead validation and documentation efforts across multiple service locations, ensuring processes, equipment, and quality systems meet internal and external regulatory requirements.
• The ideal candidate will bring strong experience in medical device process validation, equipment qualification, quality systems documentation, and cross-functional project leadership.
• This role will require collaboration with quality, manufacturing, service, regulatory, and supplier management teams across a global organization.
• They are ideally looking for someone who has a background in Project Management.

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.
• Coordinate 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.