Sr Process Validation

Katalyst CRO; Cincinnati (OH); Presencial; USD 110 000 - 140 000; Tempo integral

Resumo da oferta

Katalyst CRO is seeking a Senior Process Validation Engineer to support a large medical device manufacturer, re-establishing and standardizing global service center operations for audit readiness and regulatory compliance. The role leads validation and documentation across service locations, ensuring processes, equipment, and quality systems meet regulatory requirements.

Collaboration with quality, manufacturing, and regulatory teams is essential, with a background in project management

Qualificações

• Experience in medical device process validation and equipment qualification.
• Strong background in quality systems documentation and cross-functional project leadership.
• Familiarity with PLM processes and manufacturing validation activities.

Responsabilidades

• 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 equipment.
• Ensure equipment calibration, maintenance, and documentation are current and compliant.
• Review and update validation documentation, SOPs, work instructions, and quality records.
• Support 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 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 for onsite assessments.

Conhecimentos

Process validation

Equipment qualification

Quality systems documentation

Project management

Cross-functional leadership

Ferramentas

Windchill

Descrição da oferta de emprego

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.