Technical Validation Project Management

Patricia Rodríguez Franceschini

**** ****** **., ***** *******, TX 75054

Cell Phone: 787-***-****

Email: ***********@*****.***

hƩps://www.linkedin.com/in/patricia k rodriguez 2b8b0394 OBJECTIVE: A challenging position of manager or related field, where I can contribute with my skills and acquire knowledge through my work experience for benefit of both company and myself. SUMMARY:

Eighteen (18) years working in the pharmaceutical, medical devices, biotechnology, and manufacturing industry.

Created and develop master (commissioning and validation) plans, User Requirements, Design Specs and Review, Vendor Audits, Commissioning, System Verification, Factory Acceptance Test (FAT), IQ/OQ/PQ protocols, Traceability Matrix, testing procedures, SOPs, change control assessments and final reports, NCR, CAPA’s, Customer Complaints, etc.

Good understanding of 21 CFR Part 11, Annex 11 and part 210, 211 and 820 Regulations cGMP, GEP, GAMP, CSVLC, EHS, HIPPA, etc.

Experience with pharmaceutical, biotechnology, medical devices and industrial manufacturing unit operations like solid dosage compounding, batching, granulation, compression, cleaning, assembly, packaging, etc.

Excellent team player. Team leader, Works well with management, engineering, QA, EHS and manufacturing personnel.

US Citizen. Bilingual - English / Spanish

Ready to relocate and travel as required.

RELEVANT SKILLS

Bilingual

AutoCAD

Visio-Technical

MS Office

MS Project

MS Access

Lotus Notes

Six Sigma Tools (Minitab)

Maximo/CMMS

SAP/R3

GxP

Part 210 & 211

Part 820 & 4

CSV, GAMP 5

GHFT Guidelines

21 CFR Part 11 ER/ES

USP, EP, & JP, ANVISA

EHS program and practices oriented

ISO 9000

Mapics

ISO 13485, IEC/EN 62304

ISO 14000/14001

Document management system (EDMQ)

CAPA and Customer Complaint System

(Pilgrim)

CAPA, Change Control and Document

Management (Trackwise)

DMAIC methodology

Computerized maintenance management

system (CMMS)

ACCOMPLISHMENTS

Manage and supervise the team for the successful and timely completed a lean manufacturing layout project that obtained $1.1M in savings the first year.

Managed on schedule the qualification activities for the introducing of the new commercial product AMG-145.

Effectively managed project start-up and validation activities of the new Purified Water System in BD Biotechnology.

Effectively managed and supervise the qualification team for the FAT activities, for the Kyoto De-Nester and Auto-Trayer Machine Systems in Kyoto Japan.

Effectively managed and supervise the qualification team for the FAT activities, for the Purified Water Generation System in Siemens Colorado Springs.

Design and Qualified on schedule the new CPR Encapper Machine cups improving the production rate and reduce the DPM’s due to falling caps.

Managed on schedule capital projects on the Engineering Department with a total cost of over $500K and Saving Cost Projects above

$100K.

PROFESSIONAL EXPERIENCE

Alcon Laboratories 03/2015 to present

Sr. Engineer I – Validation Lead

Review the Equipment Qualification and CSV Site Procedures to align them with corporate guidelines and procedures.

Managed all validations, review and approve protocols and VSR’s, execute IQ/OQ/PQ Protocols, CSV, MVP, Commissioning, TMV, GR&R guidelines for new process and equipment.

Technical support and qualification project lead coordinator.

R&D Equipment Designee Coordinator

Mentor/Lilly del Caribe PR05 Project (Assignment completed) 01/2015 to 03/2015 Commissioning & Qualification Lead Consultant

Review of the Construction Documentation and TOP Packages.

Managed Commissioning and Equipment Qualification (IQ/OQ/PQ) Protocols writing, execution, Preventive Maintenance Checklist, Drawings red-lines for the modification to the existing Purified Water System.

Project Management and team leader, technical support and project coordinator, Interview, Hiring Candidates, Manage resources. Patricia Rodríguez Franceschini

2971 Ladoga Dr., Grand Prairie, TX 75054

Cell Phone: 787-***-****

Email: ***********@*****.***

hƩps://www.linkedin.com/in/patricia k rodriguez 2b8b0394 Pharma Bio-Serve/Amgen Project (Assignment completed) 10/2013 to 11/2014 Principal Validation Scientist

Managed the Equipment Qualification (IOQ) Protocols Document generation, Preventive Maintenance Checklist, Drawings red-lines for the introduction of the new commercial product (AMG-145) in building AML-01.

Execution, verification and reviewed the protocol test results.

Packaging Lines Execution, verification and reviewed the protocol test results and support

Serialization Project Support, Generation of Commissioning Summary Reports and IOQ Summary Reports.

Responsible for the Eisai/Bosch Computer life Cycle Documents (CSV), Review URS, Generate Commissioning Plan and Validation Plan Documents, review System Design Specifications, FAT and SAT Protocols, Leveraged Tests, IOQ Reports, Validation Documents Summary Reports (CSR & VSR).

Involve and be part of the team for the PFMEA to define and identified the possible risks in the process and the product for the New Inspection Line.

Generate and review the CSV Procedures to align with corporate policies. Yonkers Industries/Merck LPO Project (Assignment completed) 09/2011 to 10/2013 Senior Commissioning and Qualification Specialist and Intern Commissioning Manager

Review the Construction Documentation (CCR’s) and TOP Packages.

Managed Commissioning and Equipment Qualification activities including the writing and execution of CSV and IQ/OQ Protocols. Create the Preventive Maintenance Checklist and Drawings red-lines.

Managed the Startup Process for all utilities, Purified Water, Potable Water, Compressed Air, Nitrogen System, Steam System, Chill Water System and writing and execute the verification protocols (V&V), and HVAC System for the New Manufacturing Facilities of Merck Pharmaceuticals in Las Piedras Site, writing and execution of the Commissioning, IQ, OQ and PQ (Purified water System Only) protocols.

Managed the Facilities (GMP Rooms) qualification activities including the Commissioning Protocol generation and execution.

Managed the Fire Protection System verification activities and writing and execute the verification protocols (V&V).

Project Management Assistant and team leader, technical support and project coordinator. Pall Life Sciences 04/2008 to 09/2011

Manufacturing Engineer Intermediate

Team leader for Kaizen Group/Lean Manufacturing Process improvement.

Responsible for Challenge Procedures versus Manufacturing Process (Pvs.P).

Project Management and team leader, contractor supervisor, technical support and project coordinator.

Supervisor and assigning work to the maintenance group and Managed and Responsible for Capital Budget of $2,000,000.

Managed Quality Engineer responsibilities, inspection, and criteria for acceptance for molding injection components and products.

Managed the risk assessment team to evaluate the possible risks in the Manufacturing floor in order to perform the lean manufacturing project.

Managed the Decommissioning equipment activities, remove equipment from CMMS, Finance Books, Obsoleted SOP’s and Drawing generated and executed a decommissioning document.

Responsible of the new Part Number Creation, bill of material, manufacturing instructions procedures, assign tooling, etc.

Generate, evaluate, investigate and find a resolution for customer complaints and internal manufacturing defects at Medical Devices and Pharmaceutical facilities. Open CAPA’s and modified SOP’s and PM’s.

Design tooling (poke-yoke, go-no go) to improve the inspection of the product during the manufacturing process.

Create a portable visual aid of the Cosmetic Inspection Procedure to increase the effectiveness in the inspection table area. QRC Group (Assignment completed) 05/2007 to 04/2008 Validation/Project Specialist

Managed Commissioning, Startup Process and Qualification Activities for the RODI (Process & Purified) Water Generation System, writing and execution of CSV IQ/OQ/PQ.

Manage and Responsible of the PLC Programming in RSLogix Program and Create the recommended spare parts list and maintenance procedures.

Project Management and team leader, technical support and project coordinator and System Troubleshooting and generate the Standard Operations procedures.

Qualification of the Viswill Automated Tablet Inspection Machine Project, execution of IQ/OQ and PQ per presentation, IQ/OQ and PQ Report, Troubleshooting and Standard Operations procedures.

Assists and support in the development of Process Validation Protocols, MSA Study and reports for laboratory equipment. Patricia Rodríguez Franceschini

2971 Ladoga Dr., Grand Prairie, TX 75054

Cell Phone: 787-***-****

Email: ***********@*****.***

hƩps://www.linkedin.com/in/patricia k rodriguez 2b8b0394

Automated Labeling System Project, Writing documentation as DS, Writing and execution of IQ/OQ and PQ, IQ/OQ and PQ Report, Troubleshooting and Standard Operations procedures. IPR Pharmaceuticals (AstraZeneca) 02/2002 to 05/2007 Computer Validation/Process Engineer Associate

Managed the Equipment and CSV (IQ & OQ) protocol verification and reviewed. Supervised contracted programmers.

Project team leader and validation activities coordinator for the CTF 1 Purified Water System Phase II and Phase III, writing, and execution of CSV IQ/OQ/PQ.

Support the Qualification of IMA Tablet Compression System and packaging equipment.

Responsible for the Protocol execution for the Packaging Equipment, Torque and Retorque equipment, Tablet Filler (Lasko) and Induction Sealer Machine and Responsible of the PLC Programming in RSLogix and builder screens in Panelview Builder 1000 Program.

Managed CTF1 and CTF2 Purified Water System (Multimedia, Softeners, RO, EDI, Ozone) startup and validation process include Phase I to Phase III writing and execution of CSV IQ/OQ/PQ. Including the Final summary reports.

Managed IBC Washers and Ultrasonic Bath system startup and complete equipment/system validation activities.

Managed the Qualification of the Kanebo Automated Tablet Inspection Machine Project, execution of IQ/OQ and PQ per presentation, IQ/OQ and PQ Report, Troubleshooting and Standard Operations procedures

Managed the utilities validation activities for HVAC, Process Water, Compressed Air, Purified Water, and Facilities.

Troubleshooting and generate the Standard Operations procedures.

Project Management and team leader, contractor supervisor, technical support, and coordinator.

Support the SAP Validation and Qualification activities, execute protocols and review tests. Paciv, Inc. (Assignment completed) 10/1999 to 02/2002 Validation/ TS Engineer/Facility/Project and Reliability Engineer

Managed the Equipment and Computerized System Validation activities and Create a Full Assessment and 21 CFR part 11 Electronic Records Gap Analysis.

Develop a Utility Purified and Potable Water Assessment for Power House and identified equipment needs validation.

Supervisor and Project Coordinator responsible for the EHS and Manufacturing Department Projects.

Reorganization of the Instrumentation and standard instruments/equipment area.

Manage the development of SOP’s and Preventive Maintenance procedures of packing area.

Responsible for the development of projects in compliance with cGMP, EHS policies.

Fire Protection Coordinator and Maintenance Facility Plant Leader Assistant

Assign, approval and closing work orders for maintenance process team.

Organize the Storeroom (Inventory Room), consolidate, removal of the obsolete parts and update the spare parts list per equipment. EDUCATION & CERTIFICATIONS:

High School and Draftsman Diploma, Vocational High School Ponce, PR (1993)

BS Mechanical Engineering, Polytechnic University of PR Hato Rey, PR (June 1999)

Basic and Intermediate Vibration Analysis Course (2000)

Validation Qualification Compliance Requirements (2002)

Allen Bradley PLC 5 and SLC 500, also include RSLogix program (2003)

Introduction to SCADA Systems and Substation Automation (2004)

Validation Workshop Series Trainer (2006)

Project Management applied to Technology and System Information (16 Hours) (2010)

Project Management (PMP) with Microsoft Project 2003 (2010)

Six Sigma Green Belt/Lean Manufacturing Training (2011)

Green Belt Six Sigma Certified (2011)

Basic Autodesk Constructware Training (2011)

Basic Project Information Management System (PIMS) Training (2012)

Design Control for Medical Devices Training (2015)

Project Management Fundamentals (2015)

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