-Performed Equipment Validation Maintenance Quality Systems Review and Re-qualification for GMP equipment to ensure a maintained validated state throughout validation life cycle-Wrote, planned, and executed validation protocols (IQ/OQ/PQ) for GMP equipment and systems such as autoclaves, SIP, clean utilities, isolators, and temperature controlled rooms and chambers-SME for autoclaves (Belimed & Getinge models) to ensure compliance with EN 285 guidance related to liquid and porous equipment load patterns-Coached and mentored team members on validation methodologies to ensure compliance with internal procedures and FDA, EU, ISO, ISPE, and cGMP guidelines-Collaborated with Engineering, Operations, and Quality disciplines to determine root cause for investigations and ensure on-time closeout for validation deliverables-Provided validation risk assessment and system acceptance for GMP equipment involved in tech transfers and change controls to ensure compliance with regulatory requirements-Support delivery for customer and regulatory audit requests, deviation, investigations, and CAPA actions to satisfy identified plant KPI’s -Perform activities using a QMS such as Document Management System (DMS), Laboratory Information Management System (LIMS), and TrackWise (Change Control, Deviation, CAPA)

-Performed Equipment Validation Maintenance Quality Systems Review and Re-qualification for GMP equipment to ensure a maintained validated state throughout validation life cycle-Wrote, planned, and executed validation protocols (IQ/OQ/PQ) for GMP equipment and systems such as autoclaves, SIP, clean utilities, isolators, and temperature controlled rooms and chambers-SME for autoclaves (Belimed & Getinge models) to ensure compliance with EN 285 guidance related to liquid and porous equipment load patterns-Coached and mentored team members on validation methodologies to ensure compliance with internal procedures and FDA, EU, ISO, ISPE, and cGMP guidelines-Collaborated with Engineering, Operations, and Quality disciplines to determine root cause for investigations and ensure on-time closeout for validation deliverables-Provided validation risk assessment and system acceptance for GMP equipment involved in tech transfers and change controls to ensure compliance with regulatory requirements-Support delivery for customer and regulatory audit requests, deviation, investigations, and CAPA actions to satisfy identified plant KPI’s -Perform activities using a QMS such as Document Management System (DMS), Laboratory Information Management System (LIMS), and TrackWise (Change Control, Deviation, CAPA)

-Management of CIP performance to support site TQM Pillar initiatives, inclusive of annual CIP audit plan as well as a water and cleaning solution usage reduction project to maintain efficient CIP time and ensure cleaning compliance to State of New Hampshire Pasteurized Milk Ordinance (PMO)-SME for Clean In Place (CIP) validation of process and packaging equipment in a cGMP environment-Food Safety Design functional review for commissioning new cGMP processing equipment-CIP troubleshooting and optimization using software data analysis (FactoryTalk View SCADA)-Maintained bulk chemical compliance for safe cleaning and sanitizing concentrations-Reviewed CIP and environmental monitoring data to determine impact to product holds-Coordinated with vendors for chemical delivery and cleaning maintenance services

-Lead support for maintaining chemical stations and associated chemical handling training-Lead support for CIP validation activities and non-routine cleaning events-Planned and executed internal sanitation audits to support deliverables from CAPA and Deviations -Write documentation and train personnel to maintain adherence to FSSC 22000 standards -Supported site HACCP with Preventative Maintenance and Sanitation Schedule compliance

-Pre-operational inspections of liquid fermented product final-fill machines to support cGMP practices-Daily product evaluation to ensure safety and quality of products at various stages of process, includes use of FTIR equipment (MilkoScan and LactoScope) and rapid selective microscopy -Support for lab equipment calibration and environmental monitoring schedules

-Use of ERP software (WinMan) for interdepartmental kit creation and delivery-Refurbish post-consumer goods, such as MacBooks, for enhanced operations -Electromechanical assembly of printed circuit boards and components-Shipping/Receiving-Review and create/edit Visual Aids and BOM per customer specification -Wave solder machine operation