Validation Engineer

• Prepare and execute commissioning (URS, FAT, SAT) and qualification/validation (IQ, OQ, PQ) protocols/documents per required quality standards.

• Read, understand, verify and develop P&ID, engineering layout, engineering drawings and engineering documents.

• Prepare and execute packaging engineering studies, develop line trials and assist in enhancing packaging process efficiencies.

• Prepare, review and record keeping of packaging set-up sheets containing critical machine specifications.

• Prepare and execute qualification and temperature mapping studies for warehouse storage area and special temperature and/or RH controlled areas.

• Maintain the annual calibration program for critical process instruments (temperature controllers, pressure gauges, data loggers, etc.) to ensure they are calibrated in timely manner.

• Maintain the annual program and record keeping of documentation for compressed air testing, clean room certifications, HEPA filter testing.

• Prepare clear SOPs and assist in providing personnel training for set-up, operation and maintenance of manufacturing and packaging equipment, utility systems and qualifications.

• Assist in assessment for gap analysis, carrying out investigations for process deviations and corrective actions as needed and change controls for modifications and process enhancements to improve efficiency and quality.

• Organize and maintain documents for equipment including manuals, drawings and calibrations.

• Coordinate with other departments, as needed for engineering and validation projects

• Other responsibilities as assigned by Senior Management.