Senior Manufacturing Engineer

DOANNIE PAGAN-OCASIO

CHEMICAL ENGINEER

P.O. Box 2313 Salinas P.R. 00751 • *************@*****.*** • 787-***-****/787-***-****

QUALIFICATIONS SUMMARY

Accomplished, proactive Chemical Engineer with more than eight years of experience to offer you in Pharmaceutical industries and Medical Device acting as Process Engineer, Quality Assurance Specialist and Project Leader. Demonstrated competencies such as: developed, introduced and launched successful new products, process and technology, Project Management, Process Improvements, Quality Assurance/Audit of process and procedures, Equipment and Process Validation, Layouts Design, Equipment Supervisor, Manufacturing processes and Manufacturing investigations. Recognized for strong adherence to Quality, result oriented, self-starter, ability to work well as team member and leader, problem solving and exceptional work ethic. Proven technical, interpersonal communication, and training skills. Core competencies and professional strengths include:

 Project Management

 Project Development

 Validation Protocols preparation and execution in accordance with Internal Policies, FDA, QSR and ISO requirements

 Software Installation and Operation Qualification

 Statistical Analysis using MiniTab and MedStat.

 Gained in-depth knowledge and experience of: Ultrasonic and Laser Welding/ UV / Dispensing Automated Systems / RF / Shrink Wrapping Machines

 Knowledgeable in solid dosage equipment such as: Blender, Mixers, Metal Detector, Fluid Bed Dryers, Coaters, and Tablet Presses

 Knowledgeable of packaging automated equipment such as Uhlmann, Lakso Filler, IMA Case Packer, IMA CONTA Filler, Metal Detector, Induction Sealer, Check Weightger, labeler and Unscrambler

 FMEA, FTA and Gage R&R

 Documentation Control

 Safety Compliance

 Adapted to Multicultural teams

 Personnel Oversight

 Process Improvements

 Quality Controls

 Project Scheduling

 Quality Technology Tools

 Nonconformance and investigations

 Quality Indicators Monitoring and Reporting.

 Troubleshooting, problem solving and rout cause identification skills

 FDA, TUV and Corporate Audit Experienced

 Cross Functional Collaboration

 Knowledge of: Lean Manufacturing / Lean Six Sigma Methodology / “Just in Time’” system / Clean Room Environment

 Corrective and Preventive actions experience. Member of CAPA board

 Labeling Control

 Experienced PMA and 510K FDA submission

 ESD Control Environment

CAREER HIGHLIGHTS

 Project leader for the transfer, installation and validation of the PARADIGM® Diabetes Insulin Infusion Pump manufacturing line as part of the Medtronic Neuro/Diabetes Business Start-up burden in Juncos PR. Responsible to manage project budget of 800K to cover equipment acquisition, line installation and manufacturing process validation. Being the first employee recruited to lead the transfer activities and responsible for the recruiter, hired, trained and supervised other resources such as engineers, manufacturing personnel and technicians. Project was successfully completed one month ahead of plan.

 Fully responsible to provide post-implementation monitoring and follow-up to the manufacturing line of PARADIGM® Diabetes Insulin Infusion Pump in Medtronic Operation Company to optimized the process.

 Increased the capacity of the PARADIGM® Insulin Infusion Pump manufacturing line by 51%.

 Responsible of successfully implementation of automated pull strength equipment to eliminate destructive analysis (Pull Test) saving more than 80K per year.

 Member of the core team responsible for the installation and validation of a high-tech and high-speed Packaging Bottle Line BA, located in Wyeth Pharmaceutical, which include a worldwide unique filler machine.

 Work under FDA Warning Letter environment collaborating with a third party consultant to conquer improvement strategy and eventually a warning letter status changed by the agency.

PROFESSIONAL EXPERIENCE

Senior Quality Assurance Specialist, Packaging PPU

August 2006 – Present Wyeth Pharmaceuticals Guayama, P.R.

Provide Quality Assurance support to operation, validation and testing of final packaging products (commercial and clinical) and assure compliance with FDA, GMP regulations, guidelines and company policies. Promoted cGMP compliance within the workplace by following site cGMP procedures. Among the major responsibilities and accomplishments are:

 Provide day-to-day support to resolve Quality issues, providing guidance and compliance support to operate in accordance to agency regulations in a packaging area of solid dosages, packaged in bottle, blister cards, cyclettes and SUD (Single Unit Dispenser).

 Review, approve and assure compliance of validation documentation as part of process improvements and monitoring initiatives, new product introduction, new technology implementation, periodic re-qualification and equipment up-grades. Active member of the packaging core team responsible for the successfully implementation of Pristiq® in the packaging bottle line B4, Pristiq® in blister packaging line U-8, Rapamune® China in blister packaging line U-8 and Effexor XR® in packaging line BA (High Speed packaging Line).

 Provided Quality Assurance support for the installation and validation of a high speed Bottle Packaging Line BA, which include a worldwide unique filler machine, assuring compliance with regulations and company policies. Served as a technical liaison between QA, Technical Services and Operations to achieve project goals, process needs and met user requirements.

 Responsible to review and approve more than 100 validation documents, including cleaning validation, Equipment Functional Operating requirements, Design Requirements, IQ/OQ/PQ and PV as part of the Bottle Line BA installation project.

 Review and approve Equipment Commissioning, Enhance Commissioning, De-commissioning, IQ, OQ protocol as well support validation exercise aligned with the Master Validation Plan.

 Verify, certify and approve line cleaning/clearance and equipment set-up prior to initiate packaging process of next lot.

 Review, approve and responsible for closure of Manufacturing Investigation Reports according to FDA guidelines. Developed and implemented methods to systematically evaluate manufacturing process and equipment problems analyze process data from equipment failures, perform trend analysis to improve process/product quality, and make recommendations to prevent recurrences.

 Evaluate and approve monitoring work-plan to track effectiveness of implemented CAPAs (Effectivity Checks).

 Evaluate product impact, establish containment plan as well as correctives action and provide lot disposition recommendation when investigation record is closed using Trackwise and SAP CAPA electronic systems.

 Develop sampling plans when special testing are required such as sample size to be tested, Acceptance Quality Level (AQL) and acceptance/rejection criteria,

 Review and approve SOP’s, Master Batch Records (MBR, Components Specifications, Bill of Material and GMP work-plan commitments associated with the manufacturing operations.

 Member of the Change Control Committee as Quality representative responsible to evaluate change proposed and determined requirements to implement change assuring compliance.

 Worked under FDA Warning Letter environment collaborating with a third party consultant (Lachman) to conquer improvement strategy and eventually a warning letter status change by the agency.

 During FDA Warning Letter environment, demonstrated leader implementing and maintaining improvement activities to meet quality standards aligned with applicable GMP regulations and guidance.

 Trains staff as necessary to ensure compliance with functional, GMP, and corporate training requirements.

 Acting as recruiter, trainer and mentor for junior QA personnel, such as QA Line Monitors and QA Record Reviewer.

 Active participant during FDA, DEA, TUV and many other regulatory agencies such as Mexico and China audits. Internal / Corporate Audits as well.

Senior Manufacturing Engineer

Sep 2004 – Jul 2006 Medtronic Operations Company Neuro/Diabetes Start-Up Juncos, P.R.

Project leader for the Transfer/Implementation of PARADIGM® Diabetes Insulin Infusion Pump manufacturing line as part of Neuro/Diabetes Business Startup burden. Relocated in a short tern assignment of eight months in Northridge, California becoming an expert on the technology being transferred which included Ultrasonic Welding, Circuit Boards, Radiofrequency Communication (RF) and automated bonding machines.

 Responsible of all required process equipment acquisition, equipment Installation/Operational qualification, layout design and manufacturing line infrastructure.

 Conducted critical process characterization, such as welding and bonding, qualification, validation and FMEA prior to initiate line installation and Manufacturing Process Validation.

 Configured and maintenance of manufacturing systems such as JDE, Factory Works and SAP to support manufacturing operations in accordance with GMP regulations and company policies.

 Identifies, resolved and removed systematic limitations to task completion. Critical judgment to handle barriers and, if required, elevates more significant issues to management in order to achieve project goals.

 Acting as project leader for Qualification/Validation activities for all new products transferred since start-up; more than four new products were successfully transferred in accordance to Quality System Regulations and FDA guidance and standards.

 Developed and monitored manufacturing procedures and implement process improvement for current procedures.

 Responsible of ECO (Engineering Change Order) generation and implementation in a timely manner and error free as part of process and product improvements, including PARADIGM® Diabetes Insulin Infusion Pump software upgrades.

 Increased product yields from 86% to 92%.

 Key contributor to pass successfully FDA agency, as well as Internal/Corporate Audits, as part of the Pre-Market Approval (PMA) submission of PARADIGM® Diabetes Insulin Infusion Pump 522/722 models.

 Day-to-Day support and trouble-shoot problems associated to manufacturing process, product and equipment malfunction.

 Responsible for Non conformance investigation, reporting and establishing the corresponding correctives and preventives actions as well as the monitoring of the post implementation activities to assure effectiveness.

 Responsible for the disposition (“Use As Is”, Scrap or Re-work) of the non-conformed product (PRB) and material (MRB).

Manufacturing Engineer

Oct 2000 – Sep 2004 Medtronic Operations Company Cardiac Rhythms Management Villalba, P.R.

Provide engineering support to manufacturing process of high volume product achieving product quality and cost goals in accordance to Quality System Regulations, FDA and ISO standards.

 Developed and monitored manufacturing procedures and implement process improvement for current procedures. Responsible of ECO (Engineering Change Order) generation and implementation in a timely manner and error free.

 Responsible for tooling and equipment design to easy device manufacturability.

 Plan and execute process and equipment Qualification/Validation (including software). As well as prepare Qual/Val plan and report by collecting, analyzing and summarizing data.

 Acting as project leader for Qualification/Validation activities for all new product and technology transfers to manufacturing lines under responsibilities. In addition, revise and implement proposals for new product specification or current specifications modification (design documents).

 Design and implement layout to assure maximum efficiency of workspace. Provide support to capacity improvement initiatives (Value Stream Mapping).

 Work and implement special projects to reduce Total Product Cycle Time, Quality major offenders and Fully Allocated Product Cost.

Water Consultant and Sales Representative

Jan 1999 at Oct 2000 Water Management Associate Bayamón, P.R.

 Acting as sale representative and consultant in the industrial water treatment system, working in accordance to GMP’s, USP requirement and federal and local environmental regulations.

 Sales industrial water treatment equipment and services, such as Reverse Osmosis, DI Water treatment, Softeners, UV Lamp, Water System Sanitization, among others.

Assistant in the Industrial Inspectors Area

Jan – Aug 1997 Preventive Industrial Medicine of South, Inc Mayagüez, P.R.

 Advisor in the Health and Occupational Security.

 Inspection of equipment and security system and offered recommendations to prevent accidents in the work area.

 Provided information about federal and local regulations, like OSHA, EPA.

TECHNICAL SKILLS

 Knowledge in cGMP, FDA Regulations. Focused in Quality, efficiency and productivity.

 Knowledge in 21 CFR Part 11

 Full Knowledge in computer literature (Hardware and Software). Platforms: Microsoft Windows® 2007, XP and Vista, and Microsoft SQL Server. Microsoft Office® (Word, Power Point, Excel, Outlook, Access, Project, Visio)

 Skilled in FactoryWork® as a user and administrator. FactoryWork® tracks all aspects of discrete manufacturing production providing defect tracking, product traceability, route and materials enforcement, and provide a complete and accurate product genealogy.

 Proficient in TrackWise® System, this is a fully configurable software tool that provides a robust, flexible, stable, and simple to use solution for tracking QA, QC, and Regulatory investigations.

 Proficient in SAP CAPA, SAP Change Control and SAP Material Management modules.

 Able to work in group or independently. Work Under Pressure

 Highly effective leadership, communication, motivational and inspirational skills.

 Ability to coordinate and organize schedule so that deadlines are met.

 Written and oral communication skills in English and Spanish.

EDUCATION, TRAINING AND PROFESSIONAL MEMBERSHIPS

M.S. Master of Business Administration-Technology Management Candidate

(Expected Graduation on Dec, 2009) - University of Phoenix, Guaynabo Campus

Certification in Biotechnology Science, Interamericana University, Guayama Campus

B.S. in Chemical Engineering, University of Puerto Rico – Mayagüez Campus

Academy of Certified Quality Auditor (CQA)

José Rodríguez-Pérez, Secretary ASQ CQM, CQA, CQE, CSSBB & CHA

Basic Concepts in Cleaning and Cleaning Validation

Destin LeBlanc from Steris

Lean Manufacturing, Primex 2004

Introduction to Design of Experiment and Its Procedures using Minitab

David R. Gonzales Barreto UPR RUM

Capital Investment Analysis

Lianabel Oliver Bigas, MBA, CPA, CMA

Member of American Society for Quality (ASQ)

REFERENCES

 Available upon request

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