Project Manager Scrum Master

Emmitt E. Griffie

* ******* *****

Palm Coast, FL 32164 USA

My broad experience includes many years’ experience as a Program Manager/Project Manager and several years of Legal Compliance/Government Affairs work, including GxPs and toxic substances. My continuing education and experience include completion of: Customer Service Training Programs, Continuous Quality Improvement Programs, ISPE Aseptic Facility Design & Construction, Computer Systems Validation (including Enterprise, Control Systems, and LIMS) Projects, and the UCSD Drug Discovery/Quality Management Systems Courses.

My experience includes successfully managing multi-million dollar project assignments to completion: both on schedule and within budget. Additionally, I have performed as a team player and individual technical contributor on some highly specialized engineering assignments. My written and oral communications skills have been highly complimented on several occasions, and I believe that good communications are the key to success in any position.

EMMITT E. GRIFFIE, PMP

9 Ranston Place; Palm Coast, FL 32164; Cell: 404-***-****; *********@*****.***

SUMMARY

Expertise in the management of engineering projects, validation, contract management, control systems, total quality management, deliverables, GAMP Guidelines, and FDA regulations’ (21 CFR Parts 11, 58, 210, 211, 820, etc.) & Guidance, and ISO 13485 compliance; Specialist in Waterfall and Agile PM Methodologies. Received PMP Certification in 2001; SCRUM Master Certification.

SOFTWARE: Windchill, ServiceNow, Sharepoint, Clarity, OpenWorkbench, MS Project, Pilgrim Smartsolv/ CAPA, MS Office, SAP Var. Modules (PM,MM,QM,PP,PS), Peregrine EDI S/W, Minitab, Master Control, Trackwise, AWS Cloud, Crystal Reports, MES Systems/Wonderware and OSI, SAS, PDM, Datastream 7i, DeltaV, Emerson AMS, Watson LIMS, HP/Mercury Quality Center Software, Livelink, QAD, Radley, HP ALM, Veeva Vault, SCADA

HARDWARE: IBM Systems, EDI Exchange, Foxboro Videospec, Microspec, Honeywell TDC 3000, Yokogawa Micro XL, Centum CS, Yokogawa XL-Net, Emerson Provox + DeltaV, Allen-Bradley PLCs, Andover Controls BMS.

EXPERIENCE

Consulting Assignments

JOHNSON & JOHNSON -- Remote [Palm Coast, FL] (02/23 – 02/24)

Project Manager

Johnson and Johnson Eyecare Div. (Jacksonville, FL)

J&J Manufactures Four-Billion Contact Lenses each year, via Six-Production Line/Departments

Assigned Task was to Manage Activities-to-Close Out Two Wide-Raging CAPAs, RE: 13 Non-Compliant System Implementations:

oCamstar, Description: MES Control System

oRMTS, Description: Raw Materials Tracking System

oEDHR, Description: Electronic Device History Record

oGFPS, Description: Global Finite Planning System

oCDTS, Description: Engineering Design Compiling

oCMMS, Description: Computerized Maintenance Management System

oVIBES, Description: Change Requests Management System

oGlobal 360, Description: Document Management System

oGage Insight, Description: Statistical Reporting Software

oSmarTeam, Description: Product Planning/Data Management Software

oLabware 7, Description: LIMS System, Ver. 7

oLabware 5, Description: LIMS System, Ver. 5

oeMID, Description: X-Ray Processing Software

Performed Retrospective Audits RE: GxP Systems’ Implement. and Validation Reviews; Valid./Testing Reviews of System Upgrades via TeamCenter QMS; CAPA Reviews; Project Management of SDLC SOP Upgrades via ServiceNow Program-Tracking SW.

Closed-Out the Subject CAPAs as mandated in 12 months (Report incl, Gap Assessments, Repair/Replace Recommendations.).

STAFFING LABS/COGNATE/CHARLES RIVER LABS – Memphis, TN (02/22 – 12/22)

Project Manager

CRL acquired all Cognate Lab. Facilities and hired several experienced Validation/Compliance Consultants in order to bring all relevant Compliance Documents up to CRL Standards. Performed Formal Validation/QA Reviews and Validation Testing Reviews of new L7 EMS/LIMS Implementation Documents, via MasterControl QMS. Oversaw Project Mgmt. of SDLC SOP Document Prep/Restatements.

FUJIFILM/IRVINE SCIENTIFIC – Remote [Palm Coast, FL] (12/20 – 12/21)

Project Manager

Fuji Film bought Irvine Scientific Labs. and they were looking to convert, standardize, and upgrade all compliance-related Documents. Performed Formal QA/Validation Reviews and Process Change Recommendations RE: Enterprise-wide SAP System Implementation & Validation Tasks, via MasterControl QMS and HP ALM Software. Oversaw and Documented SAP Test Script Reviews/Upgrades. Completed Plant CSV Documents and SOPs: Gap Assessments, Oversite, Quality Upgrades, and Validation.

GENENTECH, INC. – Remote [Palm Coast, FL] (06/20 – 12/20)

Project Management Specialist

Completed CSV SOPs Document Restatements and Quality Upgrades. Provided Pharmaceutical Manufacturing Processes/Control Systems Tutorials for Genentech Engineers. Completed Synchronization Check of Different Plant Location-Specific Validation Docs.

EMERGENT BIOSOLUTIONS, Inc. – Baltimore, MD (02/20 – 06/20)

Sr. Management/Validation Contractor

Completed 90-Day Rush Assignment of Computer System Validation activities and Data Integrity Assessments of Laboratory Instruments/Computer Systems to enable the Emergent QC to utilize them for Covid analyses. Performed TeamCenter Assess.

BRISTOL-MYERS SQUIBB, Inc. – Devens, MA (08/18 – 12/19)

Compliance Management Consultant

Performed Computer System Validation/Data Integrity Documentation assessments, remediation, & QA reviews/oversight for Analytical Laboratory Instruments, Systems, and Networks. Advised client on latest International Data Integrity Compliance/SOP Requirements. Utilized MasterControl CAPA Software and HP ALM Defect-tracking Software.

MIMEDX GROUP, Inc. – Marietta, GA (08/17 – 07/18)

CSV Manager/Validation Contractor

Performed Computer System Validation activities and QA reviews/oversight of Items/Documents related to MiMedx Group's ERP (QAD), Lab./Control-BY-Web, and Logistics (Radley) Computer Systems, SCADA Sys. Created, revised, and upgraded SOPs.

ALEXION – New Haven, CT (11/16 – 07/17)

Infrastructure Project Manager

This Client shut down their Bricks-and-Mortar Data Center, and moved All Applications to the Cloud; Key Transactions in Each Appl. had to be re-validated in the Cloud. Performed validation QA reviews and oversight of Items/Documents related to Alexion’s Systems Migration to the AWS Internet Cloud. Performed SAP and other Systems validation/ verification/validation strategy development, planning, resource-loading, and scheduling tasks. Oversaw and Reviewed the work products of 25 Accenture Validation Engineers.

MCCORMICK/IBM-WATSON – Hunt Valley, MD (02/16 – 10/16)

Project Manager IBM Watson POC Study

Performed management and oversight of Recipe & Research Big Data collection, compilation, masking, encryption, and submission to IBM for Watson Proof-of-Concept Study. Performed Study verification/validation strategy development, planning/scheduling tasks.

FRESENIUS MEDICAL CARE INC. – Waltham, MA (12/14 – 12/15)

CSV Team Manager, UDI Project

Performed management and oversight of validation activities required for compliance with the new FDA Unique Device Identifier (UDI) Regulations on a corporate-wide basis. Utilized Agile Methodology for S/W strategy devel., planning, resource-loading, tasks/devel.

Created and revised SOPs.

JOHNSON&JOHNSON/DEPUY/SYNTHES INC. (05/14 – 12/14)

Compliance Management Consultant

Performed manufacturing systems validation documentation remediation at a large titanium, stainless steel, and PEEK materials body-implant manufacturing facility. Doc. the UDI-required software changes needed to etching/labeling equipment/devices. Updated SOPs.

HILL-ROM HOLDINGS, INC. (05/13 – 05/14)

Sr. Consultant

Performed computer systems validation planning, documentation, layout and protocol generation/execution and Project Management for Research & Development Systems at a large manufacturing facility in Indiana. Created SOPs.

REGENERON PHARMACEUTICALS, INC. (01/13 – 04/13)

Sr. Consultant

Performed GAMP5-coordinated automated systems design, installation, execution, and validation Project Mgmt., Design Contractor oversight, and Validation Training of employees. Reviewed Installation and Plans/Upgrades to DeltaV and SCADA Systems.

JOHNSON & JOHNSON/McNEIL, INC. (12/11 – 11/12)

Sr. Consultant

Performed manufacturing/labeling/packaging line analysis/documentation; under Consent Decree performed process validation planning. Produced a labeling/packaging line validation upgrade project plan, execution, validation documents, and Report.

SHIRE HUMAN GENETIC THERAPIES (03/11 – 11/11)

Project Manager

Performed Project Management, Validation Planning Management, and WBS setup for implementation of the Watson LIMS system at Shire Human Genetic Therapies. Conducted validation training sessions for Shire Laboratory Subject Matter Experts (SMEs).

FLORIDA STATE GOVERNMENT (04/10 – 01/11)

Sr. Project Manager

Prepared FL Data Center Consolidation Charter & Project Management Plan: see [http://ssrc.myflorida.com/sts_project.html].

BOSTON SCIENTIFIC CORP. (04/08 – 12/09)

Sr. Validation Consultant/Project Manager

Worked on implementation and validation of a new Electronic Product Release Process, which included new QM Module Implement., Materials Management, Inspections, Supply Chain, and Inventory functions. QA reviewed all levels of validation life cycle documents (VP, RA, URS, FRS, SDS, TM) related to the manufacture of BSCI medical devices: catheters, balloons, and endoscopes, utilizing Windchill PDM Sys. Developed Valid. Master Plan for new line of endoscopic devices. Reviewed/updated corporate validation methodology SOPs. Prepared/QA reviewed all validation life cycle documents (VP, URS, FRS, SDS, TM) for Laboratory Instruments and CAPA/Complaints Handling Department. Performed SQA activities/tasks regarding SOPs, for SAP QM Module, SAP MM, and Datastream 7i Implementation, via Windchill PDM. Re-wrote the Datastream 7i Maintenance Management Project Plan and Test Plan.

EMERSON PROCESS MANAGEMENT CORPORATION (02/07 – 03/08)

Project Manager (FTE)

Performed MES/Manufacturing Control Systems project management, WBS design, quality reviews and assessments, and financial control for new DeltaV + SCADA control sys. in a new-construction Titanium Plant and an upgraded Dissolvable-Paper Mill Prods. project. Utilized Oracle, Clarity, and Open Workbench Suite for back-office budgeting, scheduling, profit projections, and reporting.

EDUCATION

·Pennsylvania State University -- B.S. Degree in Chemical Engineering

·Northeastern University -- M.S. Degree in, Engineering Management (Operations Research)

·University of Maryland -- M.S. Certification in Pharmaceutical Engineering

·Golden Gate University -- M.B.A. Credits in Project and Construction Management

·John Marshall Law School -- J.D. Credits in Business Law (Contracts, Legal Writing, U.C.C.)

ORGANIZATIONS

·American Institute of Chemical Engineers ·International Society for Pharmaceutical Engineering ·PMI, PMP

SUMMARY of SAP UTILIZATION

· Attended SAP Introductory Courses (BC010,CA010,MM010,FI010,PP005,SDS010) and Higher-Level Courses on HR Mod., PM Mod., MM Mod., SD Mod.

· Co-Managed Successful $12 million SAP Implementation Project at Yanbu Petrochemical Co.

· Wrote the SAP Project Implementation Plan for the Arabian Industrial Fibers Co.; Co-Managed Successful $6 million SAP Implementation Project at A.I.F.C.

· Completed LO050 – Mfg. Planning, LO250 – Config. and Organ in Mfg., and LO315 – Proc. Mgmt. Courses at SAP, AG.

Reviewed SAP HR Module customized implementation planning tools and checklists utilized by a large consulting co. Completed ASAP Package and Materials

Developed plan for order data migration for implementation into a large world-wide SAP-based fulfillment system at IBM

· Reviewed QM Module capabilities and configuration activities; completed QM Module Training Course.

Completed SAP Project validation SOPs, validation life-cycle documents, and Material Master Data compilation at APP.

· Reviewed SAP HR Module customized implementation planning tools utilized by a large USA consulting service organization.

· Reviewed and Completed ASAP Package and Materials via CBT Training Course/Completed PS Module Training Course.

· Completed a major set of MM and PM Validation Planning and Test Documents at Watson Pharmaceutical, ERP3 Project.

Managed oversight, updating, documentation, and training for SAP Maintenance & Enhancements at Genentech.

Performed SQA activities work relating to a new PM module worldwide maintenance application and QM module releases, at BSCI.

Developed the Validation Master Plan for validation of SAP’s new All-IN-One System at IMRIS in Canada.

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