Computer Machine
Resume:
SUMMARY OF QUALIFICATIONS
Over ** years of experience providing engineering and support services for the pharmaceutical industry in the areas of Validation and Technical Services. Experience has afforded exposure on validation, C&Q areas such as HVAC, Facility, Manufacturing and Packaging Equipment, CSV, Cleaning, Manufacturing and Packaging Processes. Applied the New Risk Management approach on the different stages of Validation and Engineering Management, including Troubleshooting, Start-Up, Commissioning, Equipment Re-Qualifications, C&Q activities, SOP’s and Batch Records generation and revision, and performance improvement projects, as applicable on the biotech and pharmaceutical industries. Responsible for Project Management, Protocols preparation, coordination of validation activities, field executions, provide technical project support, Deviations resolution, preparation of Summary Reports, Validation Master Plan and Validation Technical Report documents.
SELECTED EXPERIENCE
Warner Chilcott / Actavis / Allergan / TEVA (2011 - Actual)
Principal Packaging Technologist
Monitor and schedule Packaging Tech projects, providing management tools in order to guarantee a projects and activities on time.
Provide support, develop and execute stability protocol for WC3067-10F Risedronate Stability.
Provide support, develop and execute stability protocol for WC2055 Doxycline Registration Batches.
Support QA investigation team during several customer complaints.
Clinical Labeling Studies.
Product and equipment transfers
Implement New Blister Dress
Implement Serialization on Packaging lines
Packaging Technologist
Develop and execute IQ / OQ / PQ for Weiler Labeler Machine.
Execute PQ for the New Retorquer Machine.
Develop and execute IQ / OQ / PQ for Klockner Poucher Machine using new sealing side tooling.
Develop and execute IQ / OQ OCS Checkweigher for Femhrt Poucher.
Develop and execute IQ / OQ / PQ for CP-10 Automation of the Inspection/Accumulation Process
Execute WC3042 Soft gel stability lots
Transfer UPS-2 thermoformer machine products to CP-10 thermoformer machine.
Mentor Technical Group (2002 - 2011)
Validation Manager
BMS, Humacao, PR
Manage Building 37 Sampling Suites including Commissioning and Qualification.
Mylan, Caguas, PR
Manage High Potency Blister Packaging Line Project including HVAC and Facility Qualification (2 Blister Lines)
Manage High Potency Manufacturing Suite Project including HVAC and Facility Qualification.
EDUCATION
BS, Mechanical Engineering
UPR, Mayagüez
YEARS IN THE INDUSTRY: 15+
PROFESSIONAL AFFILIATIONS/MEMBERSHIPS
Member of the American Society of Mechanical Engineers
Member of the Mechanical Engineer Institute
SKILLS
Project Manager Certification
Excellent managerial skills
Bilingual (English and Spanish)
Teamwork oriented
Self-starter, responsible, well-organized, excellent interpersonal relations.
Excellent skills in computer software like Matlab, MathCAD, Windows, C++, MS Word, MS Power Point, MS Excel, AutoCAD, Adobe Acrobat, FLASH, MS Project, MS Visio
SELECTED EXPERIENCE (cont.)
IPR, Canovanas, PR
Develop and execute Computer System Validation for the Kanebo Tablet Inspection System.
Schering Plough, Las Piedras, PR
Develop and execute Computer System Validation for the Printing Labeling System.
McNeil, Las Piedras, PR
McNeil Packaging Lines initiative
oNew Blister Packaging Line 14 (6 equipments)
oBlister Packaging Line 11 (4 equipments)
oBottle Packaging Line 5 modifications for Rolaids (3 equipments)
Develop Master Validation Plan for Rolaids Manufacturing Area.
Develop and execute IQ / OQ for Eriez Product Transfer Conveyors (14 units).
Develop and execute IQ / OQ / PQ for Eriez Metal Detectors (15 units).
Develop Calibration Retirement Protocol.
Abbott, Carolina, PR
Develop and execute Computer System Validation for the Sales Force Automation Siebel 7.5., including network qualification.
ICN, Humacao, PR
Develop and execute IQ / OQ for the Vacuum System of OC Building.
Develop and execute IQ / OQ for the Waukesha Cherry-Burrell pump.
Develop and execute IQ / OQ / PQ for the Norden Cream Filling Machine.
AMGEN Manufacturing, Juncos, PR
Develop Master Validation Plan for the Dividella Syringe Line located at AML 1 - Fill and Finish.
Develop and execute Computer System Validation documentation for Syringe Line Divdella Cartoner Machine
Develop and execute FAT protocol for the Dividella Syringe Line Cartoner Machine, including discrepancies resolutions. Perfromed at Vendor Site Switzeland
Develop and execute Computer System Validation documentation for Syringe Line Groninger BD Flange Machine.
Develop and execute FAT protocol for the Dividella Syringe Line Groninger BD Flange Machine, including discrepancies resolutions. Perfromed at Vendor Site Germany
Develop and execute IQ / OQ / PQ for Syringe Line OCS Checkweigher.
Develop and execute IQ / OQ / PQ for Syringe Line PAGO Labeler.
Develop and execute IQ / OQ for Security Management System.
Develop and execute IQ / OQ / PQ for Syringe Line Groninger Label Placement.
Develop and execute IQ / OQ / PQ for Syringe Line Groninger Tray Unloader.
Develop and execute PQ for Enbrel Label Placement during label placement characterization at AML 1 Syringe Line.
Develop and execute Computer System Validation for the UMS System.
Develop and execute Addendums for Heat Tunnel.
Develop and execute Addendums for Sterilizer.
All this activities include project coordination and summary report.
SELECTED EXPERIENCE (cont.)
Pfizer, Caguas, PR
Develop and execute Geodon Product Transfer Commissioning and Qualification documents (PK Blenders (20 and 60 ft3, Drum Inverters, Roller Compacker, Cuadro Comil and Encapsulation Machine) including Facilities and Utilities.
Develop and execute Ulhmann Blister Packaging Line #5 Commissioning and Qualification documents (Blister machine, Cartoner, Case Parker and Palletizer) including Facilities and Utilities.
Develop and execute Computer System Validation for the Weiler Labeler at Bottle Lines 1, 2, 3 & 4.
oFactory Acceptance Test
oComputer System Validation Plan and Report
oRequirement Document for Computer Systems
oSystem Specification for Computer Systems
oTraceability Matrix for Computer Systems
oIQ / OQ / PQ
oSoftware Vendor Audit for Computer Systems
oPeriodic Review for Computer Systems
oBusiness Continuity Plan for Computer Systems
Develop and execute Computer System Validation for the Marchesini Cartoner.
Develop and execute Computer System Validation for the Kanebo Tablet Inspection System.
Develop and execute IQ / OQ / PQ for the Heat Induction System (Cap Sealer, Retorquer and Conveyor) for Bottle Lines 1, 2, 3 & 4.
Develop and execute IQ / OQ for Kramer Tablet Deduster (10 units).
Develop and execute IQ / OQ for Safeline Metal Detector (2 units).
Develop and execute IQ / OQ / PQ for RSS Hand Held Barcode and RSS Verifier (3 units).Develop and execute IQ / OQ / PQ for Pick and Place.
Develop and execute IQ / OQ / PQ for Lakso Empty Bottle Inspection System.
Develop Cleaning Validation Protocol for Fette Tablet Machine.
Develop Process Validation Protocol for Detrol LA 4mg.
Develop Cleaning Validation Protocol for Kanebo Tablet Inspection System.
Develop and execute Computer System Validation for the Viso Chrom Inspection System.
Develop and execute Computer System Validation for the Weiler Inline Labeler Machine.
SELECTED EXPERIENCE (cont.)
Ortho-McNeil, Manati, PR
Develop and execute Compress Air Qualification.
Janssen Ortho LLC, Gurabo, PR
Develop Operational and Maintenance Chiller SOP.
Wyeth, Carolina, PR
Develop Start-up SOP’s for WFI and RO water systems.
Develop Start-up SOP’s for HVAC System.
Cardinal Health, Humacao, PR
Develop and execute Pouches Line Project Qualification documentation (Pouches Machine, Cartoner Machine and vision system)
Develop and execute Cleaning Validation Protocol.
Execute Bottle Packaging Line IQ / OQ / PQ.
Develop and execute IQ / OQ / PQ for Klockner Blister Machine for four (4) tooling sizes.
Develop IQ / OQ for Carton Trayer Machine.
Develop and execute Computer System Validation for the Extruder System.
Develop and execute Computer System Validation for the Tote Pedestal Blender.
Cordis, San German, PR
Develop Commissioning and Summary Report of HVAC System for Phase II Building # 6.
Watson Laboratories Caribe, Humacao, PR
Develop and execute IQ / OQ / PQ for Accela Cota 60D Coating Machine.
Execute PQ for Loma Checkweigher.
Develop Final Report for Loma Checkweigher.
Develop and execute IQ/OQ for Domino Printer.
Develop Physical Security Operation Procedure for Ulhmann Blister Machine.
Develop Recipe Creation Procedure for Ulhmann Blister Machine.
Develop Final Reports for Ulhmann Blister Machine Validation.
Develop and execute IQ / OQ / PQ for 10 ft3 PK Blender Machine.
Develop and execute IQ / OQ / PQ for 5 ft3 PK Blender Machine.
Develop and execute IQ / OQ / PQ for Accela Cota Compu-Lab 36 Coating Machine.
Develop and execute IQ / OQ for Hidhland 15 ltr Insulated Portable Tank.
Develop and execute Computer System Validation for New Jersey Bronco 125 V Labeler Machine.
Watson Laboratories, Copiage New York
Execute IQ and OQ for Loma Metal Detector.
Watson Laboratories, Corona California
Develop and execute IQ / OQ for 2 qt PK Blender Machine.
Develop and execute IQ / OQ for Collete Mixer Granulator.
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SELECTED EXPERIENCE (cont.)
PharmaServ (2001 - 2002)
Computer Validation Specialist
Pharmacia, Barceloneta, PR
Provide support for the Computer Compliance Program at the Pharmacia Barceloneta site.
Performed system assessments to computerized system and prepared the following documents:
oFour Minimum Requirements Evaluation
oSystem Compliance Assessment (cover the Pharmacia’s 12 points of computer system validation program)
oSystem Assessment Exercise Gap Results
oSystem Assessment Report
o21 CFR Part 11 Gap Analysis Checklist
oApplication Gap Analysis Report for Electronic Signature/Records
o21 CFR Corrective Action Plan for Electronic Signature/Records
21 CFR Corrective Action Plan Executive Summary
Evaluated a approximately 200 systems from the following plant areas as part of the Computer Compliance Program assessments phase:
oChemical Plant
oQC Laboratory
oParenteral Operations
oHuman Resources
oEngineering
oInformation Technology
oMicrobiology
oQuality Assurance
Prepared the following Standard Operating Procedures (SOP’s) to support the site Computer Compliance Program:
oRequirement Document for Computer Systems
oSystem Specification for Computer Systems
oTraceability Matrix for Computer Systems
oSoftware Vendor Audit for Computer Systems
oPeriodic Review for Computer Systems
oBusiness Continuity Plan for Computer Systems
oValidation Plan for Computer Systems
Lead Pharmacy area in the correction phase for the Computer Compliance Program.
Prepared the following documents as part of the corrective actions to gaps identified during system assessments phase:
oInterim Strategy and Long Term Strategy Documents
oComputer Validation Plan
oRequirements Document
oSpecifications Document
oTraceability Matrix (Requirements to Specifications and Testing)
oBusiness Continuity Plan
oVendor Evaluation Report
oPeriodic Review Report
oTraining Plan
oComputer Validation Report
Performed Computer System Qualification Protocols and executed them as part of the remediation activities.
Caribbean Instruments Engineering (Summer 1997)
Validation Specialist
Analyze, tabulate and draw graphics for different parameters in the behavior of a compress machine through a year in Merck Company.
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