Pharmaceutical Engineer

Armond Lopez

E-Mail: **********@*****.***

PHONE: 215-***-****

****-**** ****** ******** ********** (Contractor) Fort Washington, PA

Computer Systems Validation Quality Assurance Lead

. Working within the McNeil Regulatory Compliance Consent Decree

Remediation project responsible for ensuring that regional and global GxP

regulated computerized systems are in full compliance with regulatory

requirements, company policies and procedures. Provides computer

validation direction and oversight to project teams by giving guidance on

computer validation requirements and by reviewing validation deliverables

to ensure compliance with company policies, procedures and GxP regulatory

requirements including but not limited to 21 CFR Parts 820, 11 and Annex

13. HH

. Have worked on the following McNeil/J&J systems: Enterprise Document

Management (EDM), Laboratory Information Management System (LIMS),

Product Quality Management System (PQMS) McNeil's Complaint Management

System, SAP - J&J Consumer Healthcare's implementation of SAPs Enterprise

Resource Planning Central Component (ECC), ROP (Read Only Portal),

various Johnson & Johnson shared systems.

. Reviewed and/or Approved the following document types: User Requirement

Specifications, Functional Requirement Specifications, Detail Design

Specifications, Compliance Plans, Test Protocols, Test Scripts,

Traceability Matrix, Summary Reports, Risk Assessments, Change Controls,

Business Process Test Plans, Migration Plans, Test Event Reports (TERs),

etc.

2003-2012 Pfizer (formally Wyeth) Collegeville, PA

General roles and responsibilities included:

Global Application Support Manager

. Managed offshore and onshore application support resources that composed

of a team of approximately 18 resources who investigated and resolved

issues related to global applications used within the Pfizer Global

Manufacturing division.

. Delegated to the proper resources reported incidences of issues of global

applications and worked with the resource to troubleshoot and resolve the

reported issue(s).

. Lead weekly and monthly meetings with department leads for status updates

on issues and reported incidences.

Global Application Subject Matter Expert (SME)

. Managed projects under change control that involved application

enhancements and bug fixes to global applications for improvements to the

business process and end users.

. Initiated Change Controls and completed Impact Assessments to determine

the impact on the system and the required testing needed. Managed the

process through to Change Control closure.

. Projects involved specific timelines and budgets that were critical for

the success of each project.

. Involved with migrating legacy systems into current Pfizer systems as

part of the integration effort and then decommissioned the legacy

systems.

. Global applications included:

- RCCM (Regulatory Conformance Change Manager) - an enterprise content

management platform using Documentum as a workflow system to manage

Chemistry, Manufacturing and Controls (CMC) changes for Pfizer

commercial products throughout the product lifecycle (PLC).

- PDM (Product Dossier Manager) - a fully customized web-based

Enterprise Computer System (ECS) using .NET technology to manage

product dossier content and to ensure that the correct regulatory

information is registered whenever a product change occurs at a plant.

Validation Manager

. Managed offshore and onshore validation resources for validation testing

activities.

. Scheduled and coordinated testing activities meeting project timelines.

. Wrote, reviewed and/or approved Test Scripts, Executed Test Results,

Master Validation Plans, Summary Reports, Protocols, SOPs, etc.

. Generated Deviation Reports and implemented corrective actions and/or

resolutions to resolve test failures.

Business Analyst

. Participated in requirement gathering activities with Wyeth European

affiliates to determine workflow activities needed for Labeling Text

submission to the local Board of Health (BOH).

. Worked on Blue Print Summary documentation related to SAP / Documentum

system requirements.

. Global applications included:

- ELIS (Enterprise Labeling and Packaging Information Solution) - Used

a web portal to integrate two strategic enterprise applications EDMS

(Documentum) for documents and SAP for data. This solution was used to

implement a best practices and standardized processes approach to

labeling and packaging change control and consisted of changes to

Labeling Text, Core Data Sheets, Packaging Artwork, Drawings,

Packaging Material Inspection Standards, Packaging Component

Specifications, Packaging Shipper Labels, and Packaging Bills of

Material.

Computer Validation Lead

. Ensured all computer systems at the Wyeth West Chester manufacturing

facility were in compliance with Wyeth conformance standards and Global

IS polices.

. Generated local Standard Operating Procedures as per Wyeth conformance

standards.

. Reacted to FDA 483 observations and investigated into root cause and

determine and implemented corrective actions.

EXPERIENCE:

2000-2003 KMI/PAREXEL Media, PA

Validation Consultant

Project assignments with Wyeth BioPharma, Andover, MA, Cardinal Health,

Somerset, NJ and Aventis, Swiftwater, PA. General responsibilities

included:

. The validation of computerized systems, manufacturing facilities, and

process preparation and review of requirement specifications and

qualification protocols. Also performed management of assigned

projects, project scheduling, tracking, resource management, client

interface and provided recommendations for corrective actions, as well

as contacting perspective clients to develop new business

opportunities.

. Prepared and executed qualification documents (IQ/OQ) for

manufacturing control systems which composed of distributed unit-level

PLCs and locally mounted I/O networked with SCADA servers and client

workstations using iBatch for Batch Management. The specifications and

design of the control systems were developed using the ISA S88.01

batch standard.

. Prepared and executed Validation Protocols (IQ/OQ) for the Labwatch

Monitoring System, 7th Generation Encapsulation Machine, 400 Kilogram

Gelatin Melter, Premier Mill Multi-Shaft Mixer, Rohrer Blister Machine

R-750 and R-550, Girton Tank Washer, Ross RPM-4 Mixer, Usifroid SMH-45

and SMH-90 Freeze Dryers, Technophar Encapsulation Machine, Soft-Gel

Drying Tunnel, BOC Freeze Tunnel, Safeline Metal Detector, Biological

Freezer CM-2000, Revco Freezer, Sancoa Labeling Machine, Systech

Vision Inspection System and HVAC System.

1998-2000 Validation Technologies King of Prussia, PA

Senior Validation Engineer

Project assignments with SmithKline Beecham, Upper Marion, PA, Novartis

Pharmaceuticals, Suffern, NY, Wyeth-Ayerst, Cherry Hill, NJ, and Merck Co,

West Point, PA. General responsibilities included:

. Performed Risk Assessments and Gap Analysis on legacy systems

. Prepared Computer Validation Protocols (IQ/OQ) based on the Risk

Assessment and Gap Analysis for Lyophilizers, Autoclaves,

Depyrogenation Tunnels, Vial Washers and Vial Fillers.

. Prepared guidelines and SOPs including: Guideline for Computer

Validation of Automated Equipment/Systems, Backup and Recovery

Procedure and Version Control Procedure.

. Prepared and executed Validation Protocols (IQ/OQ) for the Accela Cota

Tablet Coater, Granulation Suite, Datatron Monitoring System, Bottle

Unscramblers, Checkweighers, Tablet Fillers, Desiccant Feeders,

Packaging Line Supervisory Control Systems, Bottle Labelers,

Shrinkwrapper/Heat Tunnels, Cartoners, Barcode Scanners, Vision

Systems, Automatic Blister Packaging Machines, Cottoners and Bottle

Cappers.

. Executed Factory Acceptance Tests on new process equipment for a start-

up of a new packaging line.

. Performed Ladder Logic code review and simulation of input and output

functions using RSLogix programming software.

. Prepared User Requirement Specifications (URS) and Functional

Requirement Specifications (FRS).

. Prepared and executed Y2K Master Test Plan and Y2K Testing Guideline

with a item inventory containing more than 4000 items.

. Prepared Quality Assurance Plan and Configuration Management Plan

associated with Formulation PLC/SCADA and Filling PLC/SCADA of a

Tunnel/Barrier System.

. Prepared and executed Validation Protocol (IQ/OQ) for the Nikka Densok

Pinhole Ampoule Inspection Machine and prepared a Developmental Study

to determine the equipment parameter settings.

1997 - 1998 Wyeth-Ayerst Laboratories Marietta, PA

Validation Specialist

. Prepared and/or executed Validation Protocols (IQ/OQ) for Processing

Tanks and Vessels, Automatic Egg Inoculators, Met One Continuous

Particle Counter, Steam Sterilizer and a Clean-in-Place (CIP) system.

1983-1997 Ford Electronics Lansdale, PA

Troubleshooter

. Analyzed functional, in-circuit, quality control and module

conditioning failures of electrical module products. Identified root

cause of module failures using electronic instrumentation.

EDUCATION:

Drexel University Philadelphia, PA B.S., Chemical

Engineering

INTERESTS:

. Member of the International Society for Pharmaceutical Engineering.

. Research business opportunities.

. Coach soccer, enjoy tennis, bike riding, and guitar.

. Have the ability to communicate in Spanish.

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