SOKOL GxP Services

Engineer

• 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.
• Support Airflow Visualization studies (AVS) and airflow pattern evaluations, including study planning, setup, execution, video documentation, analysis, and technical report preparation, as required by the project.
• 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.

Validation Engineer – Equipment Qualification

Field Engineer

• Perform certification and performance testing of Class I, II, and III biological safety cabinets.
• Certify laminar airflow workstations, clean benches, isolators, RABS, pass-through chambers, and other HEPA-filtered containment equipment.
• Conduct cleanroom certification testing in accordance with ISO 14644 requirements.
• Perform airborne particle counting, airflow measurements, differential pressure verification, temperature and humidity monitoring, recovery testing, and room-classification assessments.
• Certify chemical fume hoods, ducted laboratory hoods, perchloric acid hoods, balance enclosures, and containment ventilated enclosures.
• Execute HEPA filter integrity testing using aerosol photometers and challenge aerosol generators.
• Conduct airflow velocity profiling, volumetric airflow measurements, face velocity testing, containment evaluations, smoke visualization studies, and airflow-pattern assessments.
• Troubleshoot airflow, containment, mechanical, electrical, and control-related performance issues.
• Operate and maintain specialized certification and testing instruments.
• Verify equipment functionality and calibration status before field deployment.
• Maintain service tools, spare parts, consumables, calibration records, and testing-equipment inventories.
• Analyze certification results against applicable standards, manufacturer specifications, and customer requirements.
• Prepare detailed certification reports, field-service reports, repair documentation, calibration records, and technical recommendations.
• Document deficiencies, non-conformances, corrective actions, and completed repairs.
• Communicate findings, deficiencies, and recommendations clearly to customers.
• Represent SOKOL GxP Services professionally during on-site customer engagements.

Field Service Technician – Controlled Environment Certification

Product Marketing

• Support Manufacturing Engineering by formatting, editing, uploading, routing, and tracking controlled documents through the Veeva document-management system
• Ensure documents align with BMS templates and formatting standards
• Move documents efficiently through review and approval workflows and become effective on schedule
• Improve document clarity, grammar, readability, and consistency while maintaining required formatting and workflow controls

Validation Engineer – Equipment Qualification

Field Service Technician – Controlled Environment Certification

Electronic Document Control Specialist – GMP