Validation Engineer

Job Title : Validation Engineer

Location : Gurnee, IL

Hire Type : Long-term Contract, Onsite

Pay Range : $50-70 / hour (W2, with full employee benefits)

Employment Type : W2 Only (No C2C)

General Summary

The Validation Engineer is responsible for supporting validation activities related to equipment, automation systems, processes, and facilities within a regulated medical device environment. This role ensures that systems and processes comply with FDA, ISO, and other applicable regulatory requirements while driving improvements in efficiency, safety, and product quality.

Key Responsibilities

Validation Activities : Develop, execute, and maintain validation protocols (IQ, OQ, PQ) for equipment, automation systems, utilities, and processes.

Automation Systems : Support validation of automated manufacturing and laboratory systems, including PLC- and SCADA-based systems, robotics, and process control systems.

Documentation : Prepare and review validation documentation including protocols, summary reports, standard operating procedures (SOPs), and risk assessments.

Compliance : Ensure validation activities meet FDA, ISO 13485, cGMP, and other applicable medical device regulatory requirements.

Process Improvements : Collaborate with cross-functional teams to identify and implement improvements to validation processes and systems.

Troubleshooting & Investigations : Support root cause investigations, corrective and preventive actions (CAPA), and deviation management related to validation.

Project Support : Participate in commissioning, qualification, and validation efforts for new equipment and automation projects.

Requirements

Professional Experience :

3–5 years of validation experience in the medical device, pharmaceutical, or biotech industry.

Hands-on experience with equipment and automation system validation.

Knowledge of FDA QSR, ISO 13485, and cGMP regulations.

Education :

Bachelor's degree in Engineering, Life Sciences, or related technical field.

Technical Skills :

Proficiency in automation and control systems (e.g., PLCs, SCADA, DeltaV, or equivalent).

Strong technical writing and documentation skills.

Familiarity with risk-based validation approaches and GAMP 5 guidelines.

Other Requirements :

Strong analytical, organizational, and communication skills.

Ability to work independently and as part of a cross-functional team.

Must be authorized to work in the United States on a W2 basis (no C2C).