Area Client Manager

• Aug 2020 - Present

Principal Process Engineer/ Project Manager

• Apr 2013 - Aug 2022

Matt Warhover is a regulated manufacturing specialist with over 20 consecutive years of experience in project management, engineering, manufacturing, operations, C&Q/ verification, and quality.Mr. Warhover has extensive CQV, Process Engineering, Manufacturing/Operations, and Quality Assurance specific experience with Aseptic Processing, Parenteral, Biotechnology, Radiopharmaceutical, and Personal Care manufacturing facilities. He has demonstrated effective technical knowledge and team leadership skills that allow him to prioritize and coordinate multiple simultaneous projects while providing mentorship to colleagues under his direct report and collaborating within a cross-functional team environment.CAREER HIGHLIGHTS • Seven (7) years spent on ISPE Great Lakes Chapter Board of Directors – Board Vice President (1 year), Board President (2 years). • Four (4) years as a Senior Executive Business Consultant for a Combination Device product manufacturing facility. • Six months as Validation Workstream Lead for two international aseptic fill/ finish facilities, providing re-qualification, remediation, and FDA Inspection Readiness support. • 1.5 years as Filling Manufacturing Science and Technology (MSAT) Engineer responsible for providing engineering support of two Automated Aseptic Filling Lines under Barrier Isolation (Liquid Fill/ Lyophilization). • One month as Senior Consultant for Aseptic Processing/ Qualification providing support for a start-up biotech company in Phase II clinical trials. • 1.5 years as Lead Process Engineer/ SME for the Formulation area of a large (>100 SKUs) API Manufacturing Facility. Show less

Senior Project Manager/ Senior Process Engineer

• Apr 2004 - Apr 2013

• Provide Senior Project Management leadership for this global company delivering small to large ($200M+ facilities) / complex projects; including design, build, startup, commissioning and completion of validation through product launch• Act as Project Transition Leader stepping in to resolve project issues to completion or provide / implement strategy until client is ready to step back in for successful resolution• Develop and maintain vendor relationships for cost management and timely delivery of functional systems / equipment• Lead as Process Engineer technical expertise for the design, build, commissioning, validation, and engineering study phases of manufacturing facilities• Provide training to senior client site personnel so that they could successfully assume responsibilities after each transition• Act as Cross-functional Lead collaborating with Process and Validation Engineers, R&D Scientists, Automation Engineers, OEM Equipment Engineers and other contract service personnel as needed to troubleshoot issues and obtain stakeholder acceptance• Provide Subject Matter Expert (SME) level technical oversight for formulation area and liquid filling systems and equipment • Facilitate a multi-discipline Product Quality Risk Assessment (PQRA) at each of the process manufacturing steps to determine true product / process user requirements• Provide mentoring support in the areas of project management, reporting, regulatory and technical expectations to bring colleagues new to the client company up to speed on expectations and execution strategy• Conduct technical investigations for Quality Assurance, performing root cause analysis using Six Sigma DMAIC principles• Perform regulatory impact reviews for upcoming process and batch record changes Show less

Nuclear Machinist Mate - Submarines

• Apr 1998 - Apr 2004

• Engineroom Supervisor qualified nuclear mechanic, submarines • Quality Assurance Supervisor • Maintenance/ Calibration Coordinator • Engineroom Supervisor qualified nuclear mechanic, submarines • Quality Assurance Supervisor • Maintenance/ Calibration Coordinator