Validation Engineer

Job Requirements:
- Education: Bachelor’s in engineering Primary focus areas: Materials, Mechanical, Industrial, Chemical Engineering or Equivalent.
-Years of Experience: 3-5 years of experience (senior level) validating manufacturing process and machines within a regulated industry (medical device manufacturing or pharmaceuticals preferred). 1-3 years of experience (junior level) in a validation related role within a regulated industry.
-Familiarity with FDA regulations.
-Ability to perform all listed responsibilities below.
-Six Sigma certification (preferred).
Day-to-Day:
One of our large Medical Device companies is seeking a Quality Validation Engineer for a large project. The Quality Validation Engineer will lead and support validation and qualification activities for heat-seal processes and related raw materials, ensuring compliant execution of IQ/OQ/PQ documentation, robust change control, and alignment with the Quality Management System (QMS).
• Author, review, and execute qualification documentation (IQ/OQ/PQ protocols and reports) for material processes, ensuring traceability to requirements and acceptance criteria.
• Lead and support implementation, qualification, and validation of new raw materials and process changes for production lines
• Support process characterization activities by preparing test strategies, data collection tools, and executed test records; compile, analyze, and summarize results to support qualification conclusions.
• Manage and support change control activities (change requests/records), including impact assessment, risk assessment (e.g., FMEA), implementation actions, and required documentation updates.
• Review, maintain, and improve controlled documents (quality procedures, test methods, and specifications) in support of process and product validation.
• Ensure qualification/validation packages are complete and compliant, including executed protocols, deviation documentation, investigations, final reports, and approvals per the QMS.
• Provide technical input to investigations, deviations, nonconformances, and CAPAs, including containment/bounding, root cause analysis, action effectiveness, and timely closure.
• Ensure day-to-day activities align with applicable requirements (FDA 21 CFR 820, ISO 13485, GxP) and support internal/external audits through documentation readiness and response support.
This role is an ongoing contract opportunity. There are both junior and senior level roles open. Both roles are onsite in Jacksonville, FL, Monday-Friday 8AM-5PM EST. Benefits include health, dental, vison, 401k, PTO, sick time, and paid holidays.
Junior compensation: $30-$37/ hour.
Senior compensation: $37-$41/ hour.
Show more Show less