Equipment Validation Engineer - Process Gas & Laboratory Systems
About The Position
SOKOL 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.
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.
- Ability to analyze, trend, and interpret test results and identify anomalies or adverse trends.
- 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.
- Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, computer-system validation requirements, and Good Documentation Practices.
- Advanced knowledge of pharmaceutical manufacturing, laboratory equipment, facilities, and utility systems.
- Ability to oversee vendors and external service providers performing qualification activities.
- 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.
Nice To Haves
- Bachelor’s degree in engineering, science, or a related discipline.
- Experience qualifying cell-therapy equipment.
Responsibilities
- 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.
- 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.
- Support related investigations, deviations, and CAPA activities.
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement plan with employer contributions
- Paid Time Off and company holidays
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
