Sr. Process Validation Katalyst Healthcares & Life Sciences - 4.0 Aurora, CO Job Details Contract 21 hours ago Qualifications Equipment service recordkeeping Quality records maintenance Equipment calibration Procedural guides Supplier management experience Document control experience within manufacturing industry Compliance audits & assessments Project management experience in manufacturing Manufacturing standard operating procedures Maintenance activity documentation Production validation processes Medical device manufacturing facility experience Quality assurance standard operating procedures Compliance documentation Leading team collaboration initiatives Internal compliance assessments Regulatory/legal compliance standards in production Collaboration with manufacturing teams Biomedical regulatory compliance Managing projects Quality audits Engineering design modification Senior level Cross-functional team management Standard operating procedures (SOPs) Quality control records management Quality control calibration Cross-functional communication Audit support Product lifecycle management 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.