• Author & execute validation protocols and summary reports on computerized systems, production, utilities, and laboratory equipment.• Initiate & close Change Controls, Deviations, and CAPAs.• Execution of SIP validation (Steam-in-Place) using Kaye Validator & Biological Indicators.• Perform process capability analysis & compile data from batch records.• Execute performance qualification on eligible instruments to satisfy calibration requirements.• Resolved critical hardware and software configuration issues in laboratory equipment.• Perform Computerized System Risk Assessments and GAP Assessments, delivering a corrective action plan.• Configure applicable computerized systems to comply with the FDA's 21 CFR Part 11.• Created and executed a system backup/data integrity procedure for production and lab equipment.• Authored SOP for new equipment & trained applicable personnel.• Perform product filter integrity testing and create test recipes for new filters.• Collaborate with multiple departments to implement new systems, procedures, and verify data integrity.• Communicate with business partners & manufacturers for service contracts, and technical/development support.• All documentation/procedures are executed in compliance with FDA, NSF & cGMP

• Configured & tuned Silos system, resolving long-term issues.• Designed & built spare parts inventory room, a system to track parts in stock & organized existing inventory.• Designed & built an air filter inventory room, a system to track filters in stock & organized existing inventory.• Developed a database of manufacturer spare parts for all machines in production & manufacturing.• Developed a database of all air filters used in the machines & building.• Revised SOPs for Engineering & Process Equipment Maintenance departments.• Created training questionnaires & preventive maintenance forms for production & manufacturing machines.• Verified production equipment rooms, tags & their Standard Operating Procedure (SOP) documents.• Perform mold size change on Blow Fill Seal (BFS) machines for different products.• Configure UET cartoner mechanical parameters to be compatible with varying box sizes.• Collaborate with Training & Development, Document Control, Engineering & Manufacturing departments.• Created a preventive maintenance schedule for 2021 and 2022 including monthly quality reports.• Perform preventive maintenance activities & engineering work orders.• Communicate with manufacturers to obtain critical parts & machine consumables. • Obtain quotes & create purchase orders for Process Equipment Maintenance department.

• Assembly of industrial low voltage distribution boards.• Develop 3D designs using AutoCAD for the assembled boards, enclosures, and produce 2D schematics.• Verify shop drawings based on tender drawings.• Author installation and operation manuals.• Supervise & support our installation team at the client location.• Breakdown maintenance of equipment.• Manage parts inventory and restock.• Maintain safety, environmental protection, and first aid equipment.