Sr. Validation Engineer @ - Support FDA regulatory efforts including Prior Approval Supplement (PAS) submission, Pre-Approval Inspection (PAI) front-room Audit interviews, & regulatory responses - Develop cGMP engineering programs such as System Impact / Component Criticality Assessment program, Calibration & Tolerance Determination program, Filter Integrity Test program, & Engineering Drawing program - Generate & execute Validation Master Plans & IQ, OQ, PQ, & PV protocols for sterile drug product manufacturers, including: clean utilities such as WFI, clean steam, & purified air systems; clean room architecture, HVAC, & environmental monitoring system; & production equipment such as depyrogenation oven, vial rinser, formulation vessel, filling line, & terminal sterilization autoclave. - Execute root cause analysis & remediation efforts for failed OQ & PQ tests for depyrogenation oven & autoclave for sterile drug product manufacturer - Lead cross-functional team to assess sterile manufacturing facility & utilities against FDA, EC, USP, ISO, & ISPE regulations/standards; generate gap analysis, risk assessment, site concepts, & remediation plan; & execute plan including repurposing of spaces & installation of security & HVAC systems - Manage routine cGMP activities such as CAPA, Deviations, Change Controls, & Internal Audit support From 2013 to Present (2 years) Greater Boston AreaProject Engineer II @ - Project lead & point-person for key clients in the Indianapolis & Chicago areas - Write & execute DQ, IQ, OQ, & PQ protocols for semi-automated assembly line for pharmaceutical CMO - Write & execute IQ, OQ, PQ, & Integration Testing protocols for automation packaging equipment for pharmaceutical distributor, including conveyor, dispensing, bottling, bagging, & picking systems - Lead team to debug & optimize inefficient conveyor systems for pharmaceutical distributor - Develop & execute custom line-capacity modeling program for pharmaceutical manufacturer - Manage comprehensive equipment PM & SOP remediation effort for pharmaceutical manufacturer - Manage development campaign to optimize critical hold times for pharmaceutical manufacturer - HVAC retrofit design for pharmaceutical formulations suite From 2010 to 2012 (2 years) Fishers, INMechanical Engineer @ - Manage execution of capital & expense projects, including: HVAC, pump, & vacuum system replacements; & relocation/installation of laboratory equipment such as fume hoods, bio-safety cabinets, ventilated balance enclosures, & mass spectrometers - Manage annual expense budget to achieve corporate objectives & satisfy internal client facility needs - Develop & manage compliant pressure vessel safety program for hundreds of site vessels & safety devices - Interpretation of ASHRAE, ANSI, ACGIH, IMC, NFPA, OSHA, EPA, & state/local regulations & standards relative to facility initiatives - Execute heat load evaluations & sizing of HVAC systems - Lead energy sustainability forum & execute HVAC energy reduction initiatives - Write operating procedures for HVAC systems, boilers, chillers, cooling towers, & water treatment systems From 2008 to 2010 (2 years) Greenfield, INMechanical Engineer @ - Manage execution of capital & expense projects, including: facility renovations, demolitions, & abatement - Manage annual expense budget to achieve corporate objectives & satisfy internal client facility needs - Manage investigational, remediation, & commissioning efforts for industrial ventilation equipment including fume hoods, bio-safety cabinets, & custom local exhaust ventilation devices - Interpretation of ASHRAE, ANSI, ACGIH, IMC, NFPA, OSHA, EPA, & state/local regulations & standards relative to facility initiatives - Execute heat load evaluations & sizing of HVAC systems - Lead energy sustainability forum & execute HVAC energy reduction initiatives From 2007 to 2008 (1 year) Greenfield, INEngineering Intern @ From May 2006 to August 2006 (4 months) Engineering Intern @ From May 2005 to August 2005 (4 months) Engineering Intern @ From May 2004 to August 2004 (4 months)

B.S., Mechanical Engineering @ Michigan State University From 2002 to 2007 Matthew Hartman is skilled in: Project Engineering, Mechanical Engineering, Validation, Qualification Testing, Commissioning, cGMP, Quality by Design, Clean Room Design, Environmental Monitoring, HVAC, Sterilization, Depyrogenation, Vial Rinsing, Packaging and Labeling, Warehousing, Conveyor Systems, Pressure Vessels, Change Control, Deviations, Root Cause Analysis, CAPA, Calibration, ISO, ISPE, USP, PDA, International..., ASHRAE, NFPA