Project Manager Engineer

ARMOND LOPEZ

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

Phone: 215-***-****

I am an Independent Contractor looking for a project within the pharmaceutical industry. As a professional that has 15 years experience within the Pharmaceutical industry, I have a variety of skills and can lead and/or assist as a Project Manager, Business Analyst, Project Coordinator, Validation Engineer, etc. I have worked with colleagues at all levels within the organization from the production worker to high level directors. I have strong people skills and have the ability to professionally interact with clients. I'm enthusiastic, self-motivated and dedicated to deliver high quality and meet project timelines.

2003-2012 Pfizer (formally Wyeth) Collegeville, PA

Manager

General responsibilities included:

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).

Managed projects that involved enhancement to global applications for improvements to the end users and business process. Projects involved specific timelines and budgets that were critical for the success of each project.

Lead weekly and monthly meetings with department leads for status updates on projects and reported incidences.

Proficient in MS Office Suite as well as the global applications supported.

EXPERIENCE:

2000–2003 KMI/PAREXEL Media, PA

Validation Consultant

Project responsibilities with Wyeth BioPharma, Andover, MA, Cardinal Health, Somerset, NJ and Aventis, Swiftwater, PA have included:

General responsibilities include the validation of computerized systems, manufacturing facilities, and process preparation and review of requirement specifications and qualification protocol. Also perform management of assigned projects, project scheduling, tracking, resource management, client interface and provide recommendations for corrective actions, as well as contacting perspective clients to develop new business opportunities.

Preparation and execution of qualification documents for manufacturing control systems 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.

Preparation and execution of 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.

Preparation and execution of qualification documentation for Change Control of Process Equipment.

1998–2000 Validation Technologies King of Prussia, PA

Senior Validation Engineer

Project responsibilities with SmithKline Beecham, Upper Marion, PA, Novartis Pharmaceuticals, Suffern, NY, Wyeth-Ayerst, Cherry Hill, NJ, and Merck Co, West Point, PA have included:

Performance of a Risk Assessment and Gap Analysis on legacy systems

Preparation of Computer Validation Protocols (IQ/OQ) based on the Risk Assessment and Gap Analysis for Lyophilizers, Autoclaves, Depyrogenation Tunnels, Vial Washers and Vial Fillers.

Preparation of guidelines and SOPs including: Guideline for Computer Validation of Automated Equipment/Systems, Backup and Recovery Procedure and Version Control Procedure.

Preparation and execution of 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.

Execution of Factory Acceptance Tests and vendor interface on the start-up of new process equipment.

Ladder Logic code review and simulation of input and output functions using RSLogix programming software.

Preparation of User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).

Preparation and execution of the Y2K Master Test Plan and Y2K Testing Guideline with a item inventory containing more than 4000 items.

Preparation of a Quality Assurance Plan and Configuration Management Plans associated with Formulation PLC/SCADA and Filling PLC/SCADA of a Tunnel/Barrier System.

Preparation and execution of a Validation Protocol (IQ/OQ) for the Nikka Densok Pinhole Ampoule Inspection Machine and the Preparation of 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, Stream Sterilizer and a Clean-in-Place (CIP) system.

1983-1997 Ford Electronics Lansdale, PA

Troubleshooter

Analyzed functional, incircuit, 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, guitar and speak some Spanish.

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