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 key responsibility of this role is supporting Process Air and CO₂ sampling activities. The engineer will coordinate and oversee the Gas Sampling Service Provider during sampling events, provide on-site technical support, review analytical results, identify anomalies or adverse trends, and support deviation investigations, as required.

Additional responsibilities include:

• Prepare, execute, and maintain commissioning, qualification, and validation (CQV) lifecycle deliverables for manufacturing equipment, critical utilities, and laboratory instruments, including test plans, protocols, traceability matrices, test scripts, and summary reports.
• Plan, coordinate, and execute qualification protocols in accordance with approved procedures and project schedules.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and other cross-functional teams to plan and execute validation activities.
• Coordinate process gas sampling activities and oversee vendors performing qualification and process gas testing. Provide on-site technical support during sampling, and review analytical results.
• Compile, review, and analyze qualification data to verify that equipment and systems meet approved acceptance criteria and are fit for intended use.
• Identify, investigate, document, and resolve qualification deviations, discrepancies, nonconformances, and failed test results in accordance with GMP requirements.
• Ensure all CQV documentation is accurate, complete, traceable, and compliant with GMP standards, applicable regulatory requirements, ALCOA+ and site procedures.
• Support equipment startup, troubleshooting, and post-qualification activities as needed to facilitate successful project execution.

Requirements

Required Qualifications

• 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 qualifying manufacturing equipment, critical utilities, or laboratory instruments in pharmaceutical, biotechnology, biopharmaceutical, cell and gene therapy, or other GMP-regulated environments.
• Demonstrated experience authoring and executing commissioning, qualification, and validation lifecycle documentation, including protocols, test scripts, traceability matrices, and summary reports.
• Experience investigating, documenting, and resolving qualification deviations, discrepancies, out-of-tolerance conditions, and failed acceptance criteria.
• Working knowledge of current GMP regulations, CQV principles, Good Documentation Practices (GDocP), ALCOA+ data integrity principles, and applicable industry guidance.
• Ability to interpret equipment specifications, P&IDs, engineering drawings, operating procedures, and qualification documentation.
• Strong technical writing, analytical, troubleshooting, organizational, and communication skills with attention to detail.
• Proven ability to work effectively in cross-functional teams, collaborating with Engineering, Manufacturing, Quality Assurance, Validation, and project stakeholders.
• Willingness and ability to work in GMP manufacturing areas, including classified cleanrooms requiring aseptic gowning.

Preferred Qualifications

• Bachelor’s degree in engineering, science, or a related discipline.
• Hands-on experience with Process Air and CO₂ sampling in a regulated manufacturing environment.
• 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