Equipment Validation Engineer - Process Gas & Laboratory Systems

About the role

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

Responsibilities

• Support the implementation, commissioning, qualification, and continued validated state of laboratory equipment, facilities, and utility systems in a regulated pharmaceutical manufacturing environment.
• 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.
• Support Process Air and CO₂ sampling activities, including escorting and overseeing the Gas Sampling Service Provider, verifying calibration and configuration of testing equipment, assisting during sampling, reviewing test results, identifying anomalies or adverse trends, and supporting related investigations, deviations, and CAPA activities.
• 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.

Requirements

• Minimum of five years of experience performing or supporting activities in a GMP-regulated environment.
• Minimum of three years of experience in equipment, facility, or utility qualification.
• Hands-on experience with Process Air and CO₂ sampling in a regulated manufacturing environment.
• Experience supporting viable and non-viable particulate testing, hydrocarbon monitoring, and dew-point testing.
• Experience supporting investigations, deviations, root-cause activities, and CAPA.
• Experience developing and executing equipment qualification and validation protocols.
• Experience preparing qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
• Advanced knowledge of pharmaceutical manufacturing, laboratory equipment, facilities, and utility systems.
• Advanced knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, computer-system validation requirements, and Good Documentation Practices.
• Strong written and verbal communication skills.
• Strong organizational and multitasking abilities in a fast-paced environment.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and database systems.

Qualifications

• Required: Bachelor's degree in engineering, science, or a related discipline.

Preferred Qualifications

• Experience qualifying cell-therapy equipment.

Benefits

• Competitive hourly rate: $45 - $50/hr.
• Medical, dental, and vision insurance.
• 401(k) retirement plan with employer contributions.
• Paid Time Off and company holidays.