Project Management

Resume of Jaime A. Rodriguez-Vega Page * of **

Jaime A. Rodríguez-Vega

Address: PMB 2128 PO Box 4956

Caguas, Puerto Rico 00726

Phone: 787-***-****

Email: j *********@*****.***

Education

BS – Computer Science, In teramerican University Puerto Rico

Certifications

Hewlett Packard MPEiX Certification, Lilly University SAP Certification, Lilly University Business Intelligence Certification, Lilly University Six Sigma Green Belt Certification, Lilly University OSCEE Certification, Lilly University Ergonomics Auditor Certification, Lilly University Project Management Professional (PMP), Project Management Institute Li lly University is Eli Lilly & Company In ternal Education Center for employee’s individual t raining program (ITP) PMP course completed, certification examination pending

Job History

Position Function Location Date

SAP I nformation

Consultant Technology Mentor, Puerto Rico Nov 2013 – present

• SAP Consultant – I PR (Astrazeneca, FDA regulated organization)

o SAP Validation remediation solution assessment for SAP Latin America (LATAM)

sites

Change management compliance GAP analysis

• 7,000 plus SAP changes analysis to identify GxP classification and

change compliance issues

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R isk assessment to identify & establish compliance remediation strategy

o Validation Plan & deliverables

Validation Plan

URS/FS

Testing (OQ, Regression, PQ)

Risk/Fault analysis for remediation action plan recommendation

TM

VR

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Position Function Location Date

Sr. Technical I nformation

Consultant Technology Pharma Bioserv, Puerto Rico September 2013 – Oct 2013

• CSV Consultant – Scienza Labs (FDA regulated organization)

o Laboratory Validation documentation design and/or review to maintain compliance

o Laboratory equipment Validation activities execution

• CSV Consultant – Merck LPO (FDA regulated organization)

o Compressed Air Room and H & K equipment (BOSCH GKF 2000, FETTE 3090i)

commissioning and qualification

Position Function Location

Date

Business Consultant I nformation Technology JC Automation, Humacao PR March

Sept 2013

• SAP Consultant ECC 6.0 – McNeil (FDA regulated organization, Consent Decree)

o Responsible for SAP Master Data maintenance as part of SAP ECC 6.0 release implementation

for a Pharmaceutical manufacturing site client. Role includes the data governance to be entered directly

i nto ECC SAP_PM and/or Collaborative Material Management Tool (cMat) which includes but not

l imited to the following elements: Functional Location /Equipment / Instrument basic data,

M aintenance Plant/Item/Group, Maintenance Strategies, ERSA material data basic, descriptions,

classes/characteristic, purchasing, material requirements planning (MRP) data, warehouse/storage

locations, bill of materials, vendor master data, purchase info record, outline agreement and source lists.

o Responsible for all related validation documentation and testing activities.

o Support business operations management to maximize management effectiveness while meeting

p roject implementation timeline and milestones.

• VmWare Validation Consultant – Abbvie ( FDA regulated organization)

o Responsible for validation activities for VMWare Virtualization Tool implementation.

VMWare configuration to meet client requirements

Validation documents design

Testing activities execution

• Validation Consultant – McNeil (Consent Decree)

o Responsible for validation & commissioning activities for USP Purified Water system.

Validation Plan

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IQ/OQ documents design & execution

Supporting documentation collection

Field Commissioning activities execution

• Vendor Audit Consultant – JC Automation

o Responsible for support JC Automation for Vendor Audit response activities from clients

( McNeil)

McNeil Vendor Audit Questionnaire evaluation for response recommendations

JC Automation operational procedures evaluation to identify improvement

opportunities (Software version control, Document Management, Security, DRP)

Sr. Business Analyst I nformation Technology Eli Lilly PR, Guayama Aug 2009 –

D ec 2010 (FDA Regulated organization)

• SAP implementation Lead – SAP ECC 6.0 & 7.0 Release Implementation Project

M anager

o Project activities – Microsoft Project (Project progress meetings, accountable for project schedule

datelines monitor/accountability) – 2 Releases implementation per year

o Integration with Global Teams for specific Site GLOBAL CORE design requirements

i mplementation

o Implementation Validation activities – Change Management (Trackwise), Validation Plan

o Collaboration with validation deliverables documents; design and execution: Validation Plan,

Requirements, Roles & Responsibilities, Design & Configuration Specs, Test Plan & scripts, Protocols,

SOP plan, Impact-assessment, Specific Site specifications, CSQ audit, Deployment, Training Plan, BCP

o Documentation maintenance using Regulus Document Management System

o Testing activities execution using Mercury Quality Center System

o Post-implementation issues solution – Stabilization meetings

o Project progress metrics

o Site manufacturing operations/Supply Chain IT Liaison for consultation & support

o Primary IT resource for projects related vendor negotiation and hardware/software purchases

o Local representative for Global SAP Center of Excellence (COE) support organization

• Business I ntelligence Project implementation Lead

o Project activities – Microsoft Project (Project progress meetings, accountable for project

schedule datelines monitor/meeting)

o Implementation Validation activities – Change Control, Validation Plan, deliverables, related

SOP’s

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o Analysis, integration and reconciliation of Business applications data into a common

replication database for reports design (Informatica, Business Objects)

o Reports Validation activities – Change Control, Requirements, Specific Site specifications,

Testing, CSQ audit, Deployment, BCP

o Development of computer software validation strategies CFR 21, part 11

o Site processes & data evaluation for process/labor improvement needs

o Site business areas meetings for improvement opportunities identification

o Primary I t resource for vendor negotiation and hardware purchases

o Business reports customization to meet site specific requirements for metrics/process-labor

i mprovement (Business Objects) – 1 Million dollar plus site savings since project implantation

on 2008 – Global M I &CS Productivity Award

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• SAP Data Steward & Application Analyst – SAP Master Data configuration Subject

M at ter Expert (SME)

o Material Extension to local plant – I tem Master Basic/MRP & Purchasing Data/Purchase

i nfo-records/Source List/Quality info-records/BOM/Recipe configuration/Warehouse

Strategies/IDOCS

o SAP modules primary support

MM (Views, Inventory control, stock activities, stock requirements, process order

maintenance, BOMs, Recipe’s, resources, production version, Inbound/outbound

deliveries, inventory audit trail/genealogy analysis(material document list), sales

orders)

P2P (Purchase Orders, Vendors, MRP)

WM (startegies, storage types, replenishments, transfer requests, t ransfer orders,

cyclecount, shipments, STO’s)

QM (Batch maintenance, inspection lot maintenance, Batch usage decision, Batch

results recording worksheet, Batch genealogy)

PM (PI-Sheet maintenance, batch workcenter maintenance)

o SAP/Trackwise/Regulus/ GLIMS/Maximo/Darwin applications interfaces

configuration/validation/Testing

o Batch record maintenance (Regulus)

o Lab systems integration (SAP/Darwin)

o Post-implemetation maintenance following site GxP/FDA CFR requirements

o GxP, GAMP, ISO regulations IT primary support

o SAP related validation documents & SOP’s Periodic Reviews

o OSCEE data auditor for annual site certification

• Health & Safety (H&S) I T representative

o Facilities Safety auditor

o Site areas Ergonomics auditor

o Site H &S Team representative

Business I ntegrator I nformation Technology Eli Lilly PR, Guayama Nov 2005 –

A ug 2009

Project management (SAP Releases implementation, Business Intelligence (Informatica, Business Objects)),

SAP Data Steward (Master Data) & application support (MM, WM, PP, PM, QM, APO), OSCEE business data

certification

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Business Consultant I nformation Technology Eli Lilly (I N, I ndianapolis) Apr 2002 –

Nov 2005

Project Management (SAP, Catalyst & Wireless Infrastructure (RF) implementation for PR sites)

• Business representative for implementation activities

o Business requirements gathering

o Liaison with SAP Global Teams for solution design and delivery

o Solution Testing (Integration, System, User level) – Informal, Formal, Stabilization using

Mercury Test Director Tool for automated testing – Indianapolis, Indiana

o Cutover Outage BCP activities

o Post-implementation stabilization support

o SAP WM/Catalyst integration (IDOCS)

o SAP application support (MM, WM, PP, PM, QM, APO)

I T CSV Advocate I nformation Technology Eli Lilly PR, Carolina May 2000 – Apr

2002

IT CSV (procedures maintenance), Warehouse management application support

I T Systems Adm I nformation Technology Eli Lilly PR, Carolina May 1997 – Apr

2000

Systems Administration (HP3000 MPEiX), Y2K IT Operations Team Lead

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ISS Systems Analyst I nformation Technology Eli Lilly PR, Carolina Apr 1995 –

M ay 1997

Warehouse & Manufacturing activities support

I SS Tech Programmer I nformation Technology Eli Lilly PR, Carolina Dec 1993 –

A pr 1995

ISS BCP procedures implementation

Systems Adm I nformation Technology Boots Pharmaceuticals Jan 1990 –

D ec 1993

Systems Administration (HP3000)

Systems Operations I nformation Technology Western Digital May 1987-

Dec 1990

Systems Operation (HP3000, DEC)

Skills & Strengths

Six Sigma & Project Management Methodologies (Microsoft Project) - Team Leading, validation

activities supervision, progress meetings, CAPA’s implementation within timeline

Business Intelligence Methodology (Informatica, Business Objects) – Report development, data

m igration

Business Systems Applications (SAP (ECC 5, 6, 7)), Catalyst WMS, Trackwise, Regulus, Delta V,

L IMS) – Release Management Leading, support

Change & Document Management Systems (Collaborative Material Management (cMat),

T rackwise, Documentum, Regulus, HP Quality Center (Testing))

Supply Chain Lifecycle (OSCEE, Inventory & Warehouse Management, Mfg Operations, Finance) –

i mplementation, support

Change Management & Validation Methodologies (CSV, CSQ, Policies and Standards) – IT projects

validation, application compliance state maintenance, periodic reviews

Health & Safety Methodologies (Safety inspections & Audits, Ergonomic Evaluations)

Wireless Infrastructure - LAN & RF Devices configuration & validation

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CSV & CSQ Methodologies - CFR 21, part 11, GMP, GAMP, SDLC, ISO

SAP Subject Matter Expert (IM, WM, QM, MO, OTC (SD), P2P, APO)

Virtualization Tools – VMWare

Languages:

Spanish, English (fluent)

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Awards, Recognitions & Memberships

1993 – Lilly Del Caribe IT BCP policies and procedures design and implementation

1993 -1995 – PRISEMA (Puerto Rico Information Systems Emergency Management Association): member

1997 – IT Project of the Year – Eli Lilly Systems Financial change to Foreign Company (Lilly del Caribe)

2000 – IT project of the Year – Y2K project implementation

2002 – 2005 – Global Business Implementation Project (GBIP) – SAP/Catalyst implementation in Puerto Rico

sites

2002 – 2003 – SAP Wireless Infrastructure & RF implementation in Puerto Rico sites

2007 – 2008 – Business Intelligence Project implementation in PR sites

2008 – Global MI &CS Productivity Award – Business In telligence implementation

References

Available upon request

Contact this candidate