Sterile Engineer

Job Purpose:

The incumbent supports the Unit Engineering and Operations Team on the Asset Reliability and Maintenance techniques and carries the overall accountability to improve the Equipment and Area availability by reducing downtime and ensuring unit remains compliant to regulatory, safety and Audit requirements.

• Asset Design & Integrity: Review and revise Asset design and operations methodology to enhance performance, Reliability and integrity of the Equipment and Facility.
• Equipment Qualification : Lead Qualification and Validation implementation by use of advanced appropriate tools and technologies with a First Time Right Approach.
• Technical Assistance : Lead team to conduct thorough technical investigations on critical failures of Assets and process and suggest proper corrective measures to ensure to build robust Assets and Processes.
• Compliance Review: Drive gap assessment on regulatory guidance , best Industry practices , OEM recommendations and 483s for Equipments, HVAC, Calibrations, Smoke studies, Validations, etc & timely closure on identified gaps through unit engineering team.
• Capability: Build Engineering Capability to improve quality & adequacy Equipment Health, HVAC, Qualification, Validation, Investigation, Technical Writing & Documentation.