Matthew Damick Email & Phone Number

Noblesville, IN, US

Boulder, Colorado, United States

United States

• Quality Assurance partner for production and laboratory equipment, automation, facilities, utilities, and IT infrastructure implementation, validation, and change management
• Site Change Control program owner and Data Integrity lead
• Validation Program owner – program, policies, procedures, and template development and implementation. Validation training and quality oversight
• Validation project management

Longmont, Colorado, United States

• Quality Engineering partner for site/manufacturing automation and IT infrastructure and high-purity utilities (water and gases) implementation and change management
• QA Change Control SME and global continuous improvement team site QA rep
• Go-to QA SME for global automation projects
• QA oversight for change control, non-conformance investigations, CAPAs, effectiveness checks for automation and high-purity utilities
• Trainer for Change Control program and non-conformance investigation and QA approver roles

Boulder, Colorado

• Manager, Quality Engineering
• Lead Quality Engineering team providing oversight of Facilities Engineering & Automation, Manufacturing Sciences & Technology, Laboratory systems, and IT.
• Change Control program site lead – led multi-site team upgrading the change control process from paper to electronic records, including training and procedural development. Proposing & coordinating process improvements.
• Quality Engineering – Microbial upstream processing, automation, & IT QA Lead – reviewer / approver of local and enterprise IT, manufacturing systems, PC-controlled lab systems change controls and related deliverables.
• Led multi-site Change Control (CC) process mapping team to transition from paper-based records to electronic Change Control management
• Product team QA lead – Weekly client communication – including CC and deviation record notification / approvals. Review & approval of New Product Introduction & Product Re-introduction change control records, process.

Ft. Collins, CO

• QA IT Specialist
• Development & execution of computerized systems lifecycle & qualification program
• Oversight of computer & IT systems validation & change control
• System administrator (data, configuration, and user account management & troubleshooting) for Quality System EDMS. Developed and administered EDMS training & user guide.

Lakewood, CO

• Process Validation Lead / Engineer IV
• Owned, developed, and executed Process Validation program integrating risk-based approaches (pFMEA) including training validation, manufacturing, and R&D engineers
• Process validation SME for regulatory and internal quality audits
• Managed site Validation Master Plan and periodic validation maintenance / revalidation activities, including development of user requirements and requirement traceability matrices (RTMs)
• Development and execution of process and equipment requirements, validation plans, protocols, reports, trace matrices, and risk assessment & mitigation documentation

Longmont, Colorado

• Automation Validation Program Manager / Sr. Validation Engineer
• Owned and developed plant automation engineering program compliant with cGMPs, good engineering practices, GAMP5 and ASTM E2500 – including program improvement and related training
• Automation validation SME for regulatory and internal quality audits
• Change control validation assessor
• Creation, execution, and review / approval of automation and equipment commissioning, qualification, and validation documents
• Automation validation lead for small projects (~$25K) to large (multi-million-dollar budgets)Managing groups of up to 10 contractors

• IS Computer Validation Support (CVS) Team Manufacturing Professional
• Reviewed/approved computer validation for automated fill & finish equipment, process support systems, batch recipe management systems, utilities, CMMS, and information systems
• Computer validation and 21 CFR 11 compliance audits
• Site CSV program team member and team mentor and new-hire trainer

• Validation Specialist
• Authored and executed automation and equipment validation protocols for sanitary utilities, process support systems, bioreactors, and purification equipment
• Use of programmable data acquisition tools (e.g., Kaye Validators) and hand-held instruments

Development of SOPs and batch production records supporting a blood plasma processing facility start-upEquipment qualification for HVAC, chromatography, filtration, and buffer preparation systems

Manufacture, quality control, and process engineering for Magneto Rheological Fluids Operated under ISO/QS-9000 and utilized Design of Experiments & Statistical Process Control

Development and implementation of cGMP-compliant SOPs for a vaccine manufacturing facilityExecution of process and equipment validation

Training, manufacture, assembly, and quality assurance inspection of prescription eyewearCalibration, maintenance, and troubleshooting lens manufacturing machinery

Bs, Chemical Engineering

Activities and Societies: Volleyball, weightlifting, woodwind performance for symphony, jazz band, church praise band Sr. ChemE Project.

Hs Diploma, Science, Mathematics, Instrumental Music

Activities and Societies: Marching Band, Symphonic Band, Orchestra, Jazz Band, Academic Quiz Team

Education record