Franklin Padilla

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Experienced Pharmaceutical Industry Project Manager
Franklin Padilla's Location
United States, United States
Franklin Padilla's Contact Details

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About Franklin Padilla

MANAGEMENT PROFILE:Management Leader with accomplished successful history in sterile manufacturing operations, QA, validation, technical services, packaging engineering, capital projects, product transfer, third party manufacturing, project management and facilities divestiture. Outstanding record in clean rooms facilities construction, plant expansion, budget control, technology transfer, problem solving and process improvements programs which resulted in yields optimization, reducing plant accidents rate, process validation compliance and meeting production goals.NOTABLE CONTRIBUTIONS:♦ Designed and prepared the Pfizer Global Manufacturing Arecibo Site Decommissioning Plan. ♦ Developed with Schering Corporate Packaging Engineering a new vaginal applicator ($3MM) and Nasonex nasal spray presentation ($4MM). Two new product lines were designed, installed and started-up.♦ Conducted the project management of the Schering Plant Expansion for the manufacture of Albuterol inhalation solution product ($17MM). Two high speed aseptic filler/cappers (500 cpm) packaging lines were installed and process validated. ♦Technical Course Lecturer at TERRA FARMA, S.A. de C.V., Mexico City, Mexico: FEB 2008. Training Course Program: “Design and Remodeling of Pharmaceuticals Plants, How to Salvage Legacy Plants? How to be Successful with New Plants? Minimum Requirements to Consider”. CORE COMPETENCIES:♦ Sterile Operations ♦ Project Management ♦ Validation ♦ Change Control Management ♦ Leadership ♦ Packaging Engineering ♦ Process Support ♦ Third Party Manufacturing ♦ Plant Decommissioning ♦ Technology Transfer ♦ Product and Process Cost Reduction ♦ Yield and Quality Improvement ♦ Strong Analytical Problem Solving ♦ Facilities Divestiture

Franklin Padilla's Current Company Details

Experienced Pharmaceutical Industry Project Manager
Franklin Padilla Work Experience Details
  • Pfizer
    Divestiture D & D Project Engineering Lead
    Pfizer May 2012 - Oct 2013
    Pfizer Global Manufacturing, Carolina, Pr
    PFIZER GLOBAL MANUFACTURING, Carolina, PR: Sterile Operations Site for the manufacture of Penicillin Products (Zosyn) and Non-Penicillin Products (Tygacil) to supply company Domestic and International distribution pipe line. Pfizer approved the close-out of this site in 2012 and transfer the products manufacturing to its new facility in Catania, Italy. Site Divestiture Project was started in May 2012 for the process and systems decommissioning and divestiture (Site sell or demolish). Plant operations ceased in September 2012. Plant demolition work was completed in October 2013.DIVESTITURE PROJECT ENGINEERING LEAD (Share Tech Group Consultant), MAY 2012 – OCT 2013♦ Prepared and processed the RFP’s for the A/E Design Firm, Construction Management Contractor, Construction General Contractor and Demolition General Contractor for the Divestiture Project. ♦ Managed the successful preparation and approval of the Plant Demolition Design within budget and time. ♦ Supported Finance and Pfizer Corporate Engineering groups in the preparation and approval of the Divestiture Capital project appropriation. ♦ Project Supplement Contracts were negotiated with all four main Contractors, approved and project started on time.♦ Managed all project Contractors for the successful demolition of seven of ten buildings and a 100% project completion.
  • Pfizer
    Project Engineering Consultant
    Pfizer Jun 2009 - May 2012
    Pfizer Glbal Manufacturing, Barceloneta, Pr
    PFIZER GLOBAL MANUFACTURING, Barceloneta, PR: Bulk and Drug Products Manufacturing Site for the manufacture of API molecules and final products manufacturing to supply company Domestic and International distribution pipe line. Infrastructure and process improvements projects were approved for execution.PROJECT ENGINEERING CONSULTANT (FITS & ISS Corp.), JUNE 2009 – MAY 2012Coordinated with A/E firm, API Operations, Engineering, Project CM, EHS and Utilities the design, fabrication, installation, start-up and validation of the following infrastructure and process improvement projects:♦ Purified Water System (PWS) Runners and Loop extension to supply four API buildings. Project validation was completed in May 2012. ♦ Purified Water System (PWS) to supply the Drug Product building. PWS validation report was completed and release in March 2012.♦ Installation new API Varenicline Bulk Product Fitzpatrick Mill with product containment and Isolator system to handle OEB 4 products. Equipment was purchased, FAT and delivered in August 2011.♦ New API Exemestane Bulk Product Hosokawa Mill with product containment. Equipment was purchased and delivered in May 2011.♦ Technical supported the major clean-up; repair and start-up of API process contaminated Scrubber.♦ Managed the decommissioning of Pfizer API Organic Synthesis Chemical Plant: Cruce Davila, PR.
  • Pfizer
    Project Engineering Consultant
    Pfizer Sep 2006 - Mar 2009
    Pfizer Global Manufacturing, Arecibo, Pr
    PFIZER GLOBAL MANUFACTURING, Arecibo, PR: Bulk and Drug Products Manufacturing Site for the manufacture of API molecules and final products manufacturing to supply company Domestic and International distribution pipe line. Infrastructure and process improvements projects were commissioned for execution.PROJECT ENGINEERING CONSULTANT (ISS Corp.), SEP 2006 – MAR 2009Designed and developed the preparation and execution management of the Pfizer Global Manufacturing Arecibo Site Decommissioning Plan. ♦ Managed Site Decommissioning Plan execution, final report completion and change control approval of the decommissioning plans of the Pfizer Global Manufacturing Arecibo Site. ♦ Managed a fast track Site Plant Building Materials Inventory & Characterization Survey required for the demolition of Site facilities.
  • Eli Lilly And Company
    Validation Technical Support Consultant
    Eli Lilly And Company Feb 2004 - Aug 2006
    Lilly Del Caribe, Carolina, Pr
    LILLY DEL CARIBE, Carolina, PR: Biotechnology Products Manufacturing Site for the manufacture of API biotechnology molecules to supply company Domestic and International distribution pipe line. A new manufacturing Site was fabricated for this activity. VALIDATION TECHNICAL SUPPORT (Skanska and Fluor Daniel Caribbean), FEB 2004 – AUG 2006Lead validation technical support to the CIP & Utilities Document, Computer Systems and Cleaning Validation Execution & Purification Validation Teams on a timely manner. ♦ Investigated and prepared a technical special Incident Report of the Plant Steam System validation to overcome non-conformances issues, which resulted in compliance with validation due date.♦ Provided validation technical support to the CIP & Utilities Document, Computer Systems and Cleaning Validation Execution & Purification Validation Teams.♦ Investigated and prepared Discrepancies, Incidents and Test Problems Reports to address non-conformance issues. Reviewed forms 0/1/2/3, PCS, PQ and PV executed protocols.♦ Monitored field validations execution, P&ID walk-down, product contact components and solved technical issues on a timely manner.
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  • Wyeth
    Project Manager Consultant
    Wyeth Sep 2003 - Jan 2004
    Wyeth, Carolina, Pr
    WYETH, Carolina, PR: Sterile Operations Site for the manufacture of Penicillin Products (Zosyn) and Non-Penicillin Products (Tygacil) to supply company Domestic and International distribution pipe line. A new plant expansion was fabricated for the manufacture of Zosyn products.PLANT EXPANSION PROJECT MANAGER (ISS Corp), SEP 2003 – JAN 2004Managed the construction and validation of the Zosyn Expansion Project; Coordinated with Construction & Validation firms (Torcon & Pharma Plan-Flaval), Operations, QA and Technical Services the commissioning and validation activities of Plant Utilities (WFI, Pure Steam, Compressed Air, Nitrogen, HVAC). Construction and validation of Zosyn Expansion Project was completed on-time.
  • Schering
    Process Support Manager
    Schering Jan 1990 - May 2003
    Schering Plough Products, Llc, Manati, Pr
    SCHERING PLOUGH PRODUCTS, LLC, Manatí, PR: : Sterile and Non-sterile Operations Site for the manufacture of parenterals, ophthalmic ointments and dermatological ointments and creams to supply company Domestic and International distribution pipe line. PROCESS SUPPORT MANAGER, 1990 – MAY 2003Managed a group of professionals to support sterile pharmaceutical operations; leader of: project engineering, packaging engineering, vision systems and construction of new facilities for the manufacturing of sterile and non-sterile products.♦ Managed the implementation of remediation works of Company Consent Decree with The Quantic Group and Lachman Consultant Services, Inc. Contractors.♦ Worked with Corporate Engineering the design, construction and started-up of Plant Expansion Projects for the manufacture of sterile products, ointments and creams.♦ Transferred the Afrin and Duration Nasal Spray product lines from Kenilworth, NJ and Memphis, TN facilities, respectively.♦ Managed the design and construction of the Plant Expansion Project for the manufacture of Cooper Vision acquisitioned ophthalmic products.♦ Developed with Corporate Packaging Engineering a new vaginal applicator and Nasonex nasal spray presentation ($4MM).♦ Conducted the project management of the Plant Expansion for the manufacture of Albuterol inhalation solution product.
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  • Schering
    Process Support And Environmental Control Manager
    Schering Oct 1972 - Dec 1989
    Schering Plough, Manati, Pr
    SCHERING PLOUGH, Manatí, PR: The following position was also held in Schering (1972-1989):Process Support and Environmental Control Manager; Sterile Expansion Project Manufacturing Coordinator; Senior Process and Finishing Operations Manager, Technical Services Manager, Chemical Plant Manager and Chemical Plant Supervisor.
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Franklin Padilla Skills

Process Validation Validation Manufacturing Cleaning Validation Technology Transfer Change Control Commissioning 21 Cfr Part 11 Cgmp Capa Gmp Pharmaceuticals Sop Fda Process Improvement Quality Systems Problem Solving Process Engineering Continuous Improvement Change Management Troubleshooting Documentation Compliance Product Development Customer Relations Biotechnology Process Development Engineering Process Optimization Program Management Team Building Risk Assessment Business Process Improvement V&v Quality System Process Simulation Pharmaceutical Industry Software Documentation Quality Assurance Medical Devices Gamp Quality Auditing Computer System Validation Gxp Biopharmaceuticals Trackwise Regulatory Affairs Iso 13485 Root Cause Analysis

Franklin Padilla Education Details

Frequently Asked Questions about Franklin Padilla

What is Franklin Padilla's role at the current company?

Franklin Padilla's current role is Experienced Pharmaceutical Industry Project Manager.

What is Franklin Padilla's email address?

Franklin Padilla's email address is fr****@****qui.net

What schools did Franklin Padilla attend?

Franklin Padilla attended Polytechnic University, San Juan, Pr, University Of Puerto Rico-Mayaguez.

What skills is Franklin Padilla known for?

Franklin Padilla has skills like Process Validation, Validation, Manufacturing, Cleaning Validation, Technology Transfer, Change Control, Commissioning, 21 Cfr Part 11, Cgmp, Capa, Gmp, Pharmaceuticals.

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