Validation Engineer

Job Title: Validation Engineer
Location: Marietta, Georgia (Local Candidates Only)

Experience: 8+ Years
Type: 12+ Months Contract

About the Role

We are seeking experienced Validation Engineers to support our medical device client in Marietta, GA. This role is open exclusively to candidates based in Georgia . As part of the team, you will be responsible for developing and executing validation protocols, qualifying equipment and systems, and ensuring compliance with FDA, ISO, and international regulations.

Key Responsibilities

• Develop, execute, and maintain validation deliverables, including Validation Master Plans (VMP), IQ, OQ, and PQ.

• Support validation of molding equipment, automated/manual assembly processes, robotics, conveyors, bowl feed systems, and servo/PLC-controlled systems.

• Assess fixture/tooling qualifications, ergonomic considerations, and environmental controls.

• Conduct validation and qualification activities for MES/SCADA systems in FDA-regulated environments.

• Perform testing such as torque, vision system evaluation, and functional performance validation.

• Apply and interpret FDA QSR (21 CFR Part 820), EU MDR 2017/745, ISO 9001, and ISO 13485 requirements.

• Document all validation activities with high-quality technical writing and reporting.

• Provide training to staff on validation protocols, equipment usage, and compliance standards.

• Collaborate with design, manufacturing, and quality teams to ensure cross-functional alignment.

• Apply root cause analysis and structured problem-solving to resolve deviations and process issues.

Required Qualifications

• Bachelor's degree (or higher) in Mechanical, Biomedical, Chemical, Industrial, or related Engineering discipline.

• Strong experience with IQ/OQ/PQ protocols and equipment calibration.

• Knowledge of automated and manual assembly, robotics, and process control systems.

• Hands-on experience in medical device validation in a GMP/FDA-regulated environment.

• Proficiency in technical documentation, reporting, and compliance standards.

• Strong analytical and problem-solving skills.

Preferred Qualifications

• Certifications in ISO 14971 Risk Management and ISO 13485 Quality Management Systems.

• Six Sigma/Lean Manufacturing certification (Green Belt or Black Belt).

• GMP training and knowledge of international quality standards.

• Experience with KNEAT software (highly desirable).

Application Note

This role is open only to local candidates in Georgia . If you meet the qualifications, please apply with your updated resume through the provided job link.