Functional solution architect, MES/MOM strategy and implementations in Pharma, Biotech, Vaccines, Med Device industries. Global / multi-site implementations. Vendor selections, requirements definition, site readiness assessments, process improvements, scoping, phasing, best practices and standards. Master batch record design and implementation.Products: Werum PAS-X, Siemens OpEx Pharma, Rockwell Pharmasuite

• MBR FACTORY® Lead: Workstream lead on multiple projects to implement electronic batch records for new and existing biologics, vaccine, and pharmaceutical manufacturing operations. Responsible for conducting interactive design workshops with stakeholders across disciplines to translate user requirements into working batch records, based on industry best practices. Scope including Level 2 (automation) and Level 4 (ERP) integration.• MES Front-end Study Subject-matter expert (SME): Contributor or lead on multiple front-end study engagements to determine user requirements for MES/MOM implementations. Determination of project readiness, scope, phasing and implementation strategy, cost estimating, and return on investment. Some engagements involved software vendor selection.• Batch Record Review Lead: Lead consultant tasked with reviewing and optimizing existing paper batch records for a sterile injectables manufacturer. Responsible for conducting interactive workshops with key stakeholders to lean out and reconstruct paper-based batch records. Overall, the project reduced the selected pilot batch record by more than 30% and provided a model for site-wide implementation, with an eye toward future MES/MOM.• Lead SME: MES implementation design review for new biologics facility. Responsible for conducting interactive design review workshops and advising the project team, in-line with best practices.

• From January 2017, Senior MES Consultant in partnership with Enterprise System Partners (ESP) Global Corp (now an Accenture Industry X.0 company)• Consulting on multiple projects at Merck & Co. in a Business Analyst role, supporting MES/MOM implementations of Werum PAS-X at Clinical sites.• Multi-year consulting role for Pfizer on an implementation of SAP xMII. Involved in the full SDLC lifecycle, from business analysis/requirements through code, test, and support.

• System Architect for a multi-site MES rollout using the Simatic IT Manufacturing Execution System (MES) framework. Responsible for requirements definition, design, and testing, all utilizing UML methodology.• Conducted multiple needs analysis, site assessments, and solution consulting for major food & beverage, specialty chemical, and life sciences clients.• Supported sales and marketing activities; including major trade shows, conferences, sales calls, and engagement/project proposals.• Actively participated in MESA, serving on the Technical Committee and the Quality and Regulatory Compliance strategic initiative.• Technical Manager with 4 direct reports.

• System Architect, Technical lead, and/or developer on multiple projects involving POMS MES. This included POMS (PAL)development, report writing, utilities, and interfaces to external ERP/MRP and LIMS systems.• Two years of specific application experience in implementing a MES for Pharmaceutical clinical packaging.• Authored multiple validation documents, including User Requirement Specifications, Functional Requirement Specifications, Detail Design Specifications, Standard Operating Procedures, Installation Qualification, Operational Qualification, and Performance Qualification protocols and test scripts, Requirement Traceability Matrix, and Validation Summary Reports.• Supported sales and marketing activities; including major trade shows, conferences, sales calls, and engagement/project proposals.• Conducted independent vendor audits on behalf of pharmaceutical clients.• Certified TrackWise® consultant.

MES Systems Integrator: Consultants in manufacturing and E-business fulfillment.

Systems Integrator: Consultants primarily to the Pharmaceutical industry. PC&IT division dissolved in July, 2000 and absorbed by Interwave Technology, Inc.

Manufacturer of wet process equipment for the Semiconductor and Flat Panel Display industries. The company merged with Mattson Technologies in 2002.

Systems Integrator: Consultants to the Pharmaceutical, Steel, HVAC, and Chemical industries. The company merged and became TAVA Technologies, Inc. in 1996.

Systems Integrator: Consultants to the Pulp and Paper industry.