Equipment Validation Engineer - Process Gas & Laboratory Systems

Equipment Validation Engineer

SOKL GxP Services is seeking an Equipment Validation Engineer to support a long term assignment at the client's site in Summit, New Jersey.

This position will support the implementation, commissioning, qualification, and continued validated state of laboratory equipment, facilities, and utility systems in a regulated pharmaceutical manufacturing environment. The engineer will work with internal customers and external service providers to execute qualification activities, develop validation documentation, support equipment implementation projects, and ensure compliance with cGMP and site procedures.

A central responsibility of the role is supporting Process Air and CO₂ sampling activities. The engineer will escort and oversee the Gas Sampling Service Provider, verify the calibration and configuration of testing equipment, assist during sampling, review test results, identify anomalies or adverse trends, and support related investigations, deviations, and CAPA activities.

Additional responsibilities include:

• Develop and execute equipment qualification protocols and associated reports.
• Prepare Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
• Maintain equipment, facilities, and utility systems in a qualified and validated state.
• Supervise vendors performing qualification and process-gas testing activities.
• Develop procedures for equipment calibration and preventive maintenance.
• Support equipment implementation activities, including procurement, scheduling, site preparation, installation, qualification, and turnover.
• Provide technical guidance on equipment and computer-system qualification issues.
• Support internal and regulatory audits as a subject-matter resource when required.
• Ensure validation documentation is accurate, complete, compliant, and audit-ready.