5-7 years of experience in process validation for medical devices.
Strong understanding of regulatory compliance and audit readiness standards.
Experience in quality systems documentation and equipment qualification.
Proven ability to lead cross-functional projects effectively.
Background in Project Management highly preferred.
Responsibilities
Lead validation efforts for global service centers to ensure compliance and audit readiness.
Develop and execute protocols for equipment qualification and process verification.
Ensure compliance of equipment calibration and maintenance documentation.
Review and update standard operating procedures and quality records.
Support updates to the approved supplier list and documentation.
Manage change requests and product lifecycle management activities.
Coordinate efforts across multiple departments, driving compliance objectives and timelines.
Provide oversight for internal and external audit preparations and remediation.
Travel to service centers in Latin America and Asia for assessments.
Benefits
Opportunity to work with a leading medical device manufacturer.
Involvement in global service center operations.
Cross-functional collaboration with diverse teams.
Exposure to regulatory compliance processes on a global scale.
Opportunities for professional growth and leadership.
Full 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.
