Equipment Validation Specialist

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

Experience: 8+ Years Type: 12+ Months Contract

About the Role

We are seeking experienced Equipment Validation Specialist s 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.