manufacturing technician, Validations Engineer

EBENEZER RAMOS

*************@*****.*** • 510-***-**** • mailto:*************@*****.***

SUMMARY

I am a technical, hands-on validation engineer working with equipment, utilities, facilities, and special projects over the last 18+ years across the biotech and pharmaceutical industries. Over 10+ years working with Genentech and over 5+ years working with Bayer. Trained on GMP and cGMP.

EXPERIENCE

JLL, Junior Reliability Engineer

May 2025 - Apr 2026

● Asset verification (HVAC, refrigeration, electrical panel board, riser, laboratory equipment) ● Data gathering AVS Life Sciences - Genentech, Inc., SAP Master Data Specialist Jul 2023 - Feb 2025

● Review master data requests for accuracy and completeness ● Ensure alignment of master data with business requirements ● Provide Subject Matter expertise to D&C and PT projects to ensure alignment of drawings and drawing tags to drawing standards

● Run reports from SAP ● Identify data integrity gaps in Site Operations owned assets ● Execute data requests to remediate gaps in Site Operations owned assets

Genentech, Inc., Manufacturing Technician / Materials Management (Pre-weigh and Dispense) Aug 2021 - May 2023

● Performed Freezing and Thawing of Freeze/Thaw Tank ● Manual cleaning of filler parts and tank parts per approved SOP

● Operated and monitored Lyophilizers, Autoclaves, Ultrasonic washers, Fill machine, Vial Washer, Vial capper ● SAP ● Dispensing of production kit, daily weigh scale standardization ● Monthly inventory ● Weekly consumable restocking Tailored Management - Genentech, Inc., Manufacturing Technician Dec 2020 - Aug 2021

● Performed Tank CIP (Clean in Place) and SIP (Steam In Place) ● Manual cleaning of filler parts and tank parts per approved SOP ● Vial Washer and Vial Capper Operator ● Empty vial inspection Azzur Group - FibroGen, Senior Validation Engineer May 2020 - Sep 2020

● Performed IQ, OQ and PQ of Freezer and Refrigerator ● Authored and prepared the validation protocol and validation summary report

Hertz Corporation - Hertz, Rental Associates

Nov 2019 - Mar 2020

● Customer service, support ● Supervisory and management support Target Corporation - Target, Stocks Crew

Aug 2019 - Nov 2019

● Receiving and shipping, Inventory management and retail presentations C&A Consulting LLC - Allergan, Facilities and Engineering Support (Slope Verification Project) Apr 2019 - Jun 2019

● Installation Qualification (Slope verification) ● Utilities and manufacturing tank As-Built ● P&ID update per field verification C&A Consulting LLC - Genentech, Inc., Validations Engineer Apr 2015 - May 2019

● Out of Commissioning (OOC) for Manufacturing (Fill Finish) Area (Vial Washer, Bosch Depyrogenation Tunnel, Bosch Filler, Area Capper, Missing Stopper Detection System, Smeja Stopper Washer, Ultrasonic Washer, Leybold Lyophilizer, Girton Cart Washer). ● Equipment Base Spare part project – BOM acquisition, Field verification, ID parts not in BOM ● 5S project – Field verification and DATA acquisition of equipment and utilities Excelsus Scientific, Inc. - Grifol Diagnostic Solutions, Inc. (Formerly Novartis), Validations Engineer Oct 2013 - Mar 2015

● GMP cleaning validation of product-contacting parts used in manufacturing ● Preparation and operation of Temperature DATA Logger (Validator 2000) ● Performance Qualification of Autoclaves and Dry Heat Oven, Fermenter Steam-In Place (SIP) Stations

● Protocol revision and improvement

EBENEZER RAMOS - page 1 of 2

Technical Information Solutions LLC - Genentech, Inc., Validations Engineer Aug 2006 - Oct 2013

● GMP cleaning validation of product-contacting parts and equipment and New Product Introduction (NPI) ● Preparation and operation of Temperature DATA Logger (Validator 2000) ● Inspection of instrument calibration as part of instrument review

● Environmental Monitoring System Commissioning ● Operational verification for deionized water circulation ● Operational Qualification of Nitrogen Systems, Lyophilizers and Roto-Evaporators ● Performance Qualification of Lyophilizers, Autoclaves, Vial Washers, Depyrogenation Tunnels and Dry Heat Oven, Steris glassware and metal parts, Ultrasonic Washer, Portable Tank Clean-In-Place (CIP) and Steam-In Place (SIP) Stations, Non-condensable Gas (NCG) Technical Information Solutions LLC - Bayer Corporation, Facilities and Engineering Support Feb 2000 - Aug 2006

● Part of Facilities Reliability Team to ensure that spare parts are identified and available on site for facilities and manufacturing equipment. ● Updated Bill of Materials List to ensure that equipment has all critical spares identified. ● Performed system and equipment walk down to gather instrument and parts information and for revision of engineering drawings (As-built) ● Prepared system equipment, instrument and spare part spreadsheet for the Maintenance Department. ● Interfaced with production and plant engineering personnel for equipment and components information and verification for use in validation ● Assisted engineers in execution of validation protocols and engineering checkout procedures ● Contacted vendors and suppliers for quotations, purchases and technical specifications ● Revision of Preventive Maintenance SOPs ● Monthly monitoring of safety equipment

(Fire Extinguishers, Risers, Exit Lights and Emergency Lights) and leased assets (photocopy machines) EBENEZER RAMOS - page 2 of 2

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