Glenn Monroe Email & Phone Number

Elkton, Virginia, United States

Owner of CQV Project Management Activities, encompassing the following: Resource Allocation, Scheduling, Cost Control and Communications and CQV Deliverables completion. • Managed the critical CQV deliverables for the Centralized Standby Power 3 Phase Project ($66.5MM) to enable the integration of a new LV/MV electrical sitewide system. • Commissioned the Dual Power Feed for the Site Wide Data Center Project ($30MM) to increase robustness and reliability to the power network, ensuring continuous operation of the facilities during a power outage. • CQV Project Manager and owner of the Stormwater Projects ($100MM) by executing the operational testing of the systems Tanks and supporting instrumentation. Main activities encompassed the following: Main Emergency Shutdown Switch Interlocks, Level Indicators, and High/Low Motor Amperage Operational Tests. • Lead the CQV Engineers to execute the commissioning of 3 Fermenters and Bio-Life Safety Cabinet as part of a Laboratory Facility Upgrade Project ($3MM). • Commissioned various Lift Stations ($1MM). Work encompassed the evaluation of installation methods, operational testing and equipment release to the customer. • Supervisor and Quality Reviewer for CQV teams that developed and executed equipment verifications, IOC testing and P&IDs Walkdowns. • Upper Management/Client Facing project health lead presenter, inclusive of Financial, Schedule and visual condition walkdowns status reports.

Elkton, Virginia, United States

Owner of CQV Project Management Activities, encompassing the following: Resource Allocation, Scheduling, Cost Control and Communications and CQV Deliverables completion. • Managed the critical CQV deliverables for the Centralized Standby Power 3 Phase Project ($66.5MM) to enable the integration of a new LV/MV electrical sitewide system. • Commissioned the Dual Power Feed for the Site Wide Data Center Project ($30MM) to increase robustness and reliability to the power network, ensuring continuous operation of the facilities during a power outage. • CQV Project Manager and owner of the Stormwater Projects ($100MM) by executing the operational testing of the systems Tanks and supporting instrumentation. Main activities encompassed the following: Main Emergency Shutdown Switch Interlocks, Level Indicators, and High/Low Motor Amperage Operational Tests. • Lead the CQV Engineers to execute the commissioning of 3 Fermenters and Bio-Life Safety Cabinet as part of a Laboratory Facility Upgrade Project ($3MM). • Commissioned various Lift Stations ($1MM). Work encompassed the evaluation of installation methods, operational testing and equipment release to the customer. • Supervisor and Quality Reviewer for CQV teams that developed and executed equipment verifications, IOC testing and P&IDs Walkdowns. • Upper Management/Client Facing project health lead presenter, inclusive of Financial, Schedule and visual condition walkdowns status reports.

Lynchburg, Virginia, United States

Executed the Revalidation & Engineering Studies supporting the remediation of the FDA-483 Investigation Findings. • Closed Enema Validation conflicts causing particle sample and undocumented issues. • Authored qualification for the Glycerin process and refurbished Suppository Wheel. • Led the CAPAs investigation and solution implementation addressing operational deficiencies found for the “Summer’s Eve” product line, resulting in the CAPA closeout, reduction of operational inefficiencies (approx. $1MM) and continuous compliant manufacturing.

Lynchburg, Virginia, United States

Executed the Revalidation & Engineering Studies supporting the remediation of the FDA-483 Investigation Findings. • Closed Enema Validation conflicts causing particle sample and undocumented issues. • Authored qualification for the Glycerin process and refurbished Suppository Wheel. • Led the CAPAs investigation and solution implementation addressing operational deficiencies found for the “Summer’s Eve” product line, resulting in the CAPA closeout, reduction of operational inefficiencies (approx. $1MM) and continuous compliant manufacturing.

Norwood, Massachusetts, United States

Completed Validation Master Plan (VMP) to enable GMP/GXP facilities to manufacture the Covid Vaccine (mRNA-1273) • Author, executor, and coordinator for CQV activities directly/indirectly impacting mRNA-1273 vaccine manufacturing. • Wrote, modified, or utilized User Requirement Specifications (URS), Design Qualification (DQ), Sensor Risk Assessment (SRA), Computer System Impact Assessment (CSI), and System Configuration and Design Specifications (CDS). • Subject Matter Expert (SME) and lead consultant supporting the resolution of Parker mRNA Bag Filler operational issues/investigation findings. • Installed and validated additional shut-off valves to the Hot WFI Distribution System for system capacity expansion. • Redeveloped Zebra Printer Validations from a risk-based evaluation that successfully corrected Calibration and Preventive Maintenance processes.

Norwood, Massachusetts, United States

Completed Validation Master Plan (VMP) to enable GMP/GXP facilities to manufacture the Covid Vaccine (mRNA-1273) • Author, executor, and coordinator for CQV activities directly/indirectly impacting mRNA-1273 vaccine manufacturing. • Wrote, modified, or utilized User Requirement Specifications (URS), Design Qualification (DQ), Sensor Risk Assessment (SRA), Computer System Impact Assessment (CSI), and System Configuration and Design Specifications (CDS). • Subject Matter Expert (SME) and lead consultant supporting the resolution of Parker mRNA Bag Filler operational issues/investigation findings. • Installed and validated additional shut-off valves to the Hot WFI Distribution System for system capacity expansion. • Redeveloped Zebra Printer Validations from a risk-based evaluation that successfully corrected Calibration and Preventive Maintenance processes.

Greenville, South Carolina Area

Completed software, chemical, microbial, and utility validations for facility relocation and new product development.• Designed and deployed retrospective validation for site’s Enterprise Resource Planning (ERP) System to achieve ISO 9000 compliance, based on the FDA-483 major findings. • Designed and deployed utility validations supporting New Site Manufacturing Facilities. • Validated installation of onsite boiler system, trained personnel, and eliminated costs of outsourced DI water leading to $500K in cost savings. • Developed Monitor and Control methods for 99% IPA System to incorporate raw materials to the mixing processes.

Norfolk, Nebraska

Delivery of mechanical design and preventive maintenance validation for multiple departmental projects. • Validated Program Logic Controller (PLC), Blood Collection Washer, Corvac Vision System, and Sensor resulting in $30K savings. • Led the Design and Purchasing phases of a $250K safety project for the Syringe Transportation System resulting in $400K savings (Air-Glide Transportation System Replacement).• Designed the Scrap Barrel System capturing 80% of waste from the Syringe processes. • Resolved the errors of the BC Forming & Glazing Station resulting in saving 4-days of production time. • Analyzes Blood Collections process lines capabilities generating the expansion growth of 125% and lowered the risk documented under pFMEA.• Designed the Waste Capturing System and captured $150K of preventable Syringe's regrind in the Syringe Department.• Performed assembly instructions, test instructions, project validations, process changes, experimental requests, time studies, and vendor's specifications.• Took part in safety initiative (STOP work, Lock out/Tag out, Hands-Off, Green & Safety Committee, First Aid Training, Fire Extinguisher Training and Commitment to Zero Injuries).• Analyzed Cleaning Validation CIP for DI Water, Glass Soap and Chlorine Solution.• Researched glass tube recycling methods by fabrication using glass forge.

North New Jersey Area

• Installed various systems including Exterior Site Drainage Systems and Interior Hydrostatic Pressure Relief Systems in order to prevent water damage of the basement.• Repaired foundations which included Structural Repair for Foundations and Interior Foundation Crack Repair.• Assisted the owner of the company with consolidating waste and inventory of construction materials saving over $5,000-$10,000. • Oversaw steps of production and operation of installments of drainage system that are updated and sustainable for customers.• Worked with mechanical machinery, tools, and devices including excavators, cement mixers, conveyor belt, sump pumps (Zoeller Pumps, M53), drills, power-hammers, compressors,and wrenches.

East Hanover, New Jersey

• Created 2-D/3-D models and designed estimations/quotes to win customer's contracts.• Optimized the best designed layouts of metal stamping and injection molding.• Evaluated the clarification of dye\mold design, fabrication, and automated assemblies.• Researched the quality standards in ISO 9001 and ISO 13485.

Warsaw, Indiana Area

• Instituted training exercises for patrons to utilize Lean Six Sigma tools.• Trialed Process Validation Training methods for structured problem solving and process improvement. • Enriched knowledge in the 7 Management Tools/7 Quality Control Tools with exposure to ISO 9001, ISO 13485, CFR Title 21 Sub-chapter H (Medical Devices), and GD&T (ISO 10303).