Joseph Miranda by gabyion

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									Joseph Miranda                                                              (C) 908-875-5262
                                                     jmiranda@validationcompliancegroup.com




OBJECTIVE:
A professional Validation Project Manager with eleven years of solid performance seeking positions for
pharmaceuticals/medical device companies.

WORK EXPERIENCE:

Mar 2003 - Present, Validation Compliance Group, Somers Point, NJ

      Oct 2004 – Present, Validation Engineer, Boston Scientific, San Jose, CA
               Performing Process Failure Mode Effect Analysis for the Extrusion processes.

      Jun 2004 – Aug 2004, Validation Engineer, Amgen Bio-Pharmaceutical, West Greenwich, RI
               Executed OQPs for the BioNext Project qualifying CIP Skids, Buffer/Media/Harvest
                 tanks & Bioreactors. Conducted in-depth Installation qualifications both visually and
                 accessing Enhanced Turn-Over Package (ETOP) binders for certificates, purchase
                 reqs, and cleaning & passivations for piping/instrument installation constructs.
                 Verified/Redlined versioned P&IDs against a visual-as-built status of
                 CCA/WFI/Steam lines for tanks & utility skids.
               Validated soft phases within DeltaV Manufacturing Execution System that monitored
                 CIP/SIP recipes for Media, Buffer, Perfusion systems. Executed functional tests,
                 control loops, & alarms reflective of project requirements & design document during
                 Operational qualifications. Retrieved Batch Event journals, within Batch Editor of
                 DeltaV, plotted Pi Historian graphs as output attachment submittals

      Apr 2004 – Jun 2004, Validation Engineer, Cryonix Repository/Relocation/Clinical Trial
       Support/Transportation/Security, Rockville, Md
              Validated 24-hour temperature monitoring system (data acquisition and control
                 system - DACS) with annual probe Calibrations to include freezers, walk-ins, and
                 ambient temperature storage.

      Aug 2003 – Apr 2004, Validation Project Manager, Pfizer Global Research & Development
       Corporation, Ct
              Managed validation renovation project schedule for the Liquid Dosage Manufacturing
              Designed and managed validation activity spreadsheet for the project’s equipment.
              Writing IQ, OQ, and PQ for Lyophilizer Equipment
              Writing Validation Master Plan, which served as a guide to the overall strategy for
                 qualification/validation directly, associated with the 2004 renovation project.

      Mar 2003 – Aug 2003, Validation Engineer, ITC Medical Device Corporation, NJ
              Project engineer managing protocol preparation and executions.
              Writing Performance Qualification for automated filling machine.
              Writing IQ, OQ and PQ for primary packaging line.
              Writing Validation Plans design qualification for new process equipment.
Joseph Miranda                                                               (C) 908-875-5262
                                                      jmiranda@validationcompliancegroup.com



Jul 1999 – Mar 2003, Integrated Project Services, Hillsborough, NJ

   Jul 1999 – Mar 2003, Compliance & Validation Department; Senior Project Engineer

      Mar 2003 – Mar 2003, Validation Engineer, Schering Plough (Summit, NJ)
              Writing Compressed Air IQ, OQ protocol & HVAC IQ & OQ protocols.

      Jan 2003 – Mar 2003, Validation Engineer, Clay-Park
               Executing the Compressed Air system, Boiler system, Chiller system and HVAC
                  system.

      Dec 2002 – Dec 2002, Validation Engineer, Andrx
              Troubleshoot and execute the Compressed Air system to include non-viable testing,
                 moisture analysis, particulate testing, and Oil/mist test.

      July 2002 – July 2002, Project Manager, BlisTech Corporation
               Writing and performing FAT, IOQ protocols for Packaging line to include,
                  Unscrambler, Capsule feeder, Cottoner, Capper, Induction Sealer, Retourquer, and
                  Labeler.

      June 2002 – Dec 2002, Project Lead, Cardinal Health
               Perform IOQ and PQ qualifications for the new utilities to include HVAC System,
                 Compressed Air, and Chiller system for the new expansion facility.

      Apr 2002 - June 2002, Project Lead, Sidmak Laboratories
              Perform IOQ and PQ qualifications for the new utilities to include HVAC System,
                 Compressed Air, and Chiller system for the new expansion facility.

      Mar 2002 – Apr 2002, Project Lead, Clay Park Laboratories
              Complete Installation and Operational Qualification for the 2 HVAC systems.

      Sep 2000 – Mar 2002, Project Lead, Hoffmann-La Roche
               Awarded Process re-qualification on all utilities (clean steam, water systems etc.) in
                 the facility $700,000
               Temperature Mapping proposal for all warehouses in both Nutley and Totowa
                 awarded
               Installation and Operational Qualification of HVAC system
               Gap analysis on existing critical utilities at both Nutley and Totowa facility

      Jul 2000 – Sep 2000, Project Lead, Taro Pharmaceuticals, Haifa Bay, Israel
               Establish a Validation Master Plan for the Haifa Bay, Israel facility
               Performed audit at the facility

      Jul 2000 – Sep 2000, Project Lead,. Becton Dickinson Transdermal Systems
Joseph Miranda                                                              (C) 908-875-5262
                                                     jmiranda@validationcompliancegroup.com



                 Performed an Installation and Operational Qualification for a Thermoforming
                  Packaging Machine, model # Prime PV9000.

      May 2000 – Jun 2000, Sr. Validation Engineer, Purdue Pharma L.P. Pharmaceutical
              Currently assisting the client on modifying a Fluid Bed Processor, utilizing a
                modification qualification protocol. Items that needed to be identified are as follows:

                     Recipe      specific alarm             Security Level Function verification
                      verification
                     Front end computer screens             Replacement calibration         of     flow
                      modification                            elements
                     Batch record retrieval and             Transmitter re-scaling
                      storage

      Dec 1999 – May 2000, Project Lead, Chemo Dynamics L.P.
              Managed and lead a team of 2 validation engineer in the completion of 2 reactor
                 enclosures, with the following ancillary equipment.

                     Vacuum Oven                            10 ton Chiller
                     Vacuum Pump                            Trane HVAC
                     Condenser

      Dec1999 – Mar 2000, Project Lead, Almedica Corporation.
              Successfully qualified a HVAC system for a Class 10,000
              Submitted proposal and was awarded job for $35,000.
              Submitted 2nd proposal and was awarded job for 14 Carrier HVAC and one BAS
                 system.

      Sep 1999 – Dec 1999, Project Lead, Berlex Laboratories
               Managed and lead a team of 1 validation engineer and 1 validation specialist in
                 completion of the Q.C. Laboratories
               Project was over $50,000 and completed on schedule.
               Installation and Operational qualification was performed on the following pieces of
                 equipment:

                     Glassware Dryer                          Fume Hoods (12 units)
                     Glassware Washer (2 units)               Compressed Air Distribution
                     Electrical Distribution                  Compressed Lab Gases

      Jul 1999 – Dec 1999, Project Lead, Purdue Pharma L.P. Pharmaceutical
               Managed and lead a team of 2 validation engineer and 3 validation specialist in
                  completion of the Granulation Suite.
               Project was over $100,000 and completed on schedule and under budget by 10%.
Joseph Miranda                                                              (C) 908-875-5262
                                                     jmiranda@validationcompliancegroup.com



                Installation and Operational qualification was performed on the following pieces of
                 equipment:

                    York, 300 ton chiller                   Two York, HVAC systems
                    Building          automation            Vac-u-max, vacuum transfer system
                     systems
                    Niro, Fluid Bed Dryer                   GMP system, melting tank
                    Collette,    High       sheer           GMP system, portable tanks
                     granulator
                    Quadro, Particle sizing mill

            Achievement:
            Integrated Project Services Eagle Award.2001
            Integrated Project Services Eagle Award 1999
Joseph Miranda                                                            (C) 908-875-5262
                                                   jmiranda@validationcompliancegroup.com




1998 – Jul 1999, Nycomed Amersham, South Plainfield, NJ

   Jul 1998 – Jul 1999, Quality Control; Validation Engineer
               Started up the validation department to include but not limited to documentation,
                  templates, and Change control.
               Writing & executing installation & operational qualification
                   Isolator Technology
                     Prospective Validation - Design Qualification
                     Implemented and Executed Installation/Operational & Performance qualification
                     Software validation for Rapid Assay station.
                     Performance qualification for Infusion Systems
                     Implemented Preventive maintenance procedures

                    Contrast Imaging pharmaceutical drug
                     Validation Test Script Execution and Analysis (Executive summary)
                     Concurrent validation - Transfer Technology
                     Wrote and Executed Factory Acceptance Test, Validation Master Plan and
                     converted validation documents as standard templates for the South Plainfield
                     facility.

                Documented, validated, and executed the following equipment/process:
                     Cardiogen [sr82/rb82] generator manufacture
                     Helium polarizer in the manufacture of hyperpolarized helium gas
                     Generator potency assay station
                     PQ of iodotope solution manufacture
                     Suitability for use for generator potency assay station
                     Maximo preventative maintenance computer system
                     I/OQ of the Maximo advantage version 3.04 software system
                     I/OQ of the genie-2000 version 1.2a basic spectroscopy system
                     Engineering study for the determination of a cleaning method for Iodotope I-
                      131
                     Engineering study: bubble testing of helium-3 gas
                     Cardiogen 82 (rubidium rb 82 generator) production line
                     Environmental chamber
                     Metrology 746 va trace analyzer #02118
                     La Calhene sterility test isolator
                     Iodotope®(Sodium Iodide I-131) capsules and solutions
                     Environmental chambers
                     La Calhene air lock isolator
                     La Calhene filling - gray area isolator
                     La Calhene cold prep isolator
                     Dexon laminar air flow booth
                     Dexon portable clean booth - (large)
Joseph Miranda                                                            (C) 908-875-5262
                                                   jmiranda@validationcompliancegroup.com



                       La Calhene boat disassembly station
                       Dexon portable clean booth - (small)
                       Rb-82 infusion pump
                       Semi automated filling system
                       Suitability for use for multichannel analyzer tests used in the testing and
                        release of rb82 generator
                       Scilog lab tec pump
                       Suitability for use for multichannel analyzer tests used in the testing and
                        release of Iodotope ® I-131 solutions and capsules
                       Semi-automated wax fill/capper system for Iodotope (131)
                       Lauda, clear-view circulator, model # ma6-b
                       Iodotope® capsules and solutions stability protocol
                       Iodotope capsule/solution manufacture

                 Achievement:
                 Nycomed Amersham PACE (Performance, Achievement, Continuos Excellence)
                 Award

1993 - 1998, CORDIS, Johnson & Johnson, Warren, NJ

   Oct 1997 – Jun 1998 Packaging Engineering; Senior Operations Associate
              Design and implement engineer test protocols
              Installation and operational qualification validation for CE mark and manufacturing
                 processes within the packaging department
              Prepare DAR’s (document approval request), PM’s (preventive maintenance
                 procedures), PS’s (process specification), OM’s (operation manual), and ES’s
                 (equipment specification)
              Validated and executed the following equipment: Leco Microhardness testing
                 machine, Samco Swing Beam cutting machine, Sencorp Sentinel Bar Sealer, Quick-
                 Check Symbology Scanner, Single/Dual station Alloyd Blister Pack Machine, Clean
                 Stream Particulate Removal Station, and Pulse flow Particulate Removal Station.
Joseph Miranda                                                           (C) 908-875-5262
                                                  jmiranda@validationcompliancegroup.com




                 Achievement:
                 Johnson & Johnson Achievement Award.

   Feb 1993 – Oct 1997 Manufacturing Engineering; Senior Operations Associate
              Worked with manufacturing engineering in validation requirements for the extrusion
                & catheter laboratories by writing and implementing the following:
              Technical Process Regulations
              Preventive Maintenance procedures
              Test Methods specifications
              Hazardous Energy Control procedures
              Equipment specification in accordance to cGMP/cGLP
              QSR for medical device
              Conducted retrospective, prospective & concurrent process validation (IQ, OQ, DOE,
                PQ, PDQ, CSIQ) complying with FDA guidelines.
              Performed Failure Modes & Effect Analysis, and Kepner Tregoe analysis on current
                processes within the company.
              Assisted in the achievement and maintenance of ISO 9001, and BSI certification.

                 Achievement:
                 Completion of the extrusion lab’s validation and Johnson & Johnson’s “On The Spot
                 Award”.

1988- 1993 United States Air Force, Air Force Intelligence Command

   Aug 1990 – Sep 1992 Information Management
                Royal Air Force Base Mildendenhall, United Kingdom

   Jun 89 - Aug 1991 Information Management
                 Hellenikon Air Base, Greece

ASSOCIATION:
      International Society for Pharmaceutical Engineering
      Registered member of the Society for Pharmaceutical and Medical Device Professionals
      Registered member of the American Society of Quality

AWARDS:
     Integrated Project Services Eagle Award 2001
     Integrated Project Services Eagle Award 1999
     Nycomed Amersham PACE (Performance, Achievement, Continuos Excellence) Award
     Johnson & Johnson Achievement Award.
     Johnson & Johnson on the Spot Award. (2 times)
     Air Force Achievement medal
     Outstanding unit medal with clusters
     Air Force Commendation medal
Joseph Miranda                                                            (C) 908-875-5262
                                                   jmiranda@validationcompliancegroup.com



         Desert Storm medal
         Overseas Long tour with cluster.

SKILLS:
         Process Validation training course by Kemper-Masterson, Inc.
         Failure Modes & Effects Analysis training
         Killion Advance Extrusion Tubing Workshop Certificate
         Statistical Process Control training at Cordis
         Kepner Tregoe analysis training
         Certified Instron Trainer
         Engineering Documentation Control training
         Quality System Regulations/Medical Devices Part 820 training.
         Project Management – Leadership course
         Top Secret SCI Clearance

								
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