Project Leadership in Life Sciences | Engineering and CQV Expert | Go-To Problem Solver!At Persperity, I leverage my extensive background in project delivery, CQV and engineering to help pharmaceutical, biotech, and medical device companies overcome challenges and scale their operations. My journey has seen me manage CQV for multi-million-dollar automated manufacturing capacity expansion projects that not only enhance client revenues but also contribute to improving health outcomes globally.• 20+ Years of Experience in CQV & Project Leadership in Life Sciences• Expert in Paperless Validation & Risk-based Approach to Project Delivery• Collaboration Advocate: Building strong teams across disciplines and cultures• Problem Solver: Solving complex problems, ensuring that projects are delivered on time and within budget

o Completed Kneat Academy Certifications for Master Trainer, Power User Level 2, Power User Level 1, Administrator and End User.o Conducting Power User Level 1 training courses.o Leading multiple Kneat implementation projects across U.S., Europe and Asia including facilitating Kneat Process Mapping sessions, attending daily sprint calls, and analyzing existing CQV paper-based documents and processes to determine how to implement for electronic use.o Leading teams remotely through daily meetings, template and process discussions, mini how-to sessions, and template reviews and approvals. o Implementing new Kneat workspaces including creating Disciplines, Templates, Section Group Templates, Approval Templates, and Object Templates.o Mentoring End User and Power User 1 certified users.

• Owner o Managed day-to-day operations of a consulting firm including client relationships, sales and marketing, and networking.• CQV Lead/Project Leado Led teams remotely through daily meetings, documentation reviews and approvals, design reviews, equipment, and code changes, change management, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) activities, and Performance Qualification (PQ) preparation activities.o Led CQV projects in paperless validation system (Kneat) including being on the pilot project to analyze templates, processes, and implementation.o Provided CQV and Project Management leadership on several concurrent medical device manufacturing equipment projects across multiple sites in North America and Europe.o Provided CQV guidance during the design, build and commissioning of a medical device automated manufacturing line with connected care.o Met schedule challenges by analyzing and re-evaluating processes, identifying resource gaps, and proposing alternatives, and assessing and quantifying risk to bring projects in on-time and within budget.o Mentored CQV Leads, Validation Engineers, Validation Specialists, Engineers, Project Managers, and Quality Representatives on CQV and project management processes.o Authored and editing Engineering and CQV deliverables including: CQV Plans, User Requirements, Design Specifications, Test Plans, Engineering Studies and Reports, Test Protocols, Test Cases/Scripts, Summary Reports, Change Requests, Traceability Matrix, and Master Document List.o Facilitated User Requirement and Design Review meetings with multi-disciplinary team.

o 20 years of providing Commissioning, Qualification and Validation (CQV) and Project Lead consulting services to the Pharmaceutical industry:o Over 16 years in Device Manufacturing Asset Delivery that included delivering new automated device assembly lines (indexing and continuous motion), semi-automated device assembly lines, packaging lines, and SCADA and Serialization systems. Also, included upgrades to existing Device Manufacturing equipment.o 3 years qualifying Freeze Dryers, CIPs, Bottling Line, Washers, Freezers, Auto-claves, and other laboratory equipment.o 1 year re-validating an existing IT laboratory system.o Well versed in ISPE’s Applied Risk Management for C&Q and was part of the team to implement lean validation (ASTM e2500) on Device Manufacturing Asset Delivery projects starting in 2014.