SUMMARY

• Over 20 years of experience in pharmaceutical and medical devices in FDA regulated industries.
• Global organization experience in Quality and Manufacturing Engineering, responsible for continuous supply chain, product transfers, compliance, new product introductions (NPI), and Sustaining Engineering.
• Experienced in creating and remediating Equipment Qualification, Process Validation and Test Method Validation systems, forms and procedures.
• Trained in Six Sigma Black Belt methodology, with experience managing and executing projects in process excellence, lean manufacturing, cost reduction and process improvement.
• Highly experienced in leading Regulatory and Quality Compliance remediation projects: FDA Audits, Consent Decree, 483 warning letters, CAPA, Risk Management, Process Validation and Design Controls.
• Able to work under - pressure, positive attitude, fast learner, leader by example, team work oriented.

PROFESSIONAL EXPERIENCE

Confidential, Palm Beach Gardens, FL

Validation Quality Engineer

Responsibilities:

• Remediation of manufacturing, repairs and inspection procedures for Anspach and Synthes products (electric and pneumatic consoles, motors, attachments and foot pedals).
• Assessed current Equipment Qualification, Process Validation, Test Method Validation (TMV) System, procedures and practices and contributed to the development of new architecture, for the Global Organization (US, Europe and Asia) that included creation of new policy, procedures, protocol/report templates, test methods and remediation/validation activities and improvement of current test methods including, dimensional, visual inspections, in-process and functional test methods used to release product.
• Developed and provided training for the roll out of new global Process Validation and test method validation system.
• Created remediation strategy for various sites including US, Asia and Europe.

Confidential, Palm Beach Gardens, FL

Global Concurrent Manufacturing Engineering Manager

Responsibilities:

• In charge of Manufacturing Engineering team responsible for product transfers and new product development and introduction (NPI) to operations.
• Worked with Marketing department, project and product managers to make sure that deliverables where set appropriately and in a timely manner.
• Successfully completed 20 NPI projects involving global responsibilities for Biomet Dental facilities in Palm Beach Gardens, Florida and Valencia, Spain.
• Provided constant global support in the problem solving, root cause analysis and Product and Process Validations for both the Palm Beach Gardens and Valencia manufacturing facilities.
• Completed transfer into production of the new surface technology line of T3 roughened surface implants on time and provided full support to ensure proper launch to market.
• Supported Value Stream Manufacturing Engineering on sustaining and improvement projects as well as provided pilot cell and engineering resources for completion of these activities.
• Personally supported Compliance Master Plan (CMP) activities for the FDA Readiness, CAPA, Production and Process Controls, Design Controls, and Risk Management work streams.
• Created product based PFMEA templates and procedure as part of the Risk Management team.
• Participated in the DHF remediation as part of the Design Controls team.
• Completed FDA responses and improvements needed for FDA observations effectively and on time.
• Led efforts on remediation projects in Valencia for cleaning processes and water system improvements.
• Supported Product Transfers as cost improvement projects (Buy vs. Make).
• Completed successful BSI Audit in May 2014 as the process and equipment validation expert.
• Performed improvements to the Manufacturing Plans in order to complete successful transfers into production.
• Revamped and created new procedures for Global Process Validation System in order to comply with FDA regulations. Created all new IQ/OQ/PQ protocol and report templates, process monitoring procedures, Deviation forms and Engineering study templates for the documentation and characterization of process improvements and process changes.
• Managed budget effectively and worked well with other multifunctional teams and peers.

Confidential, Palm Beach Gardens, FL

Product Transfer Manufacturing Engineer

Responsibilities:

• Project leader for the transfer of products and CNC machines from China to Palm Beach Gardens Confidential site.
• Generated all documentation regarding transfers quality plans, change requests, routers, BOM’s, control plans project plans, validations, machining jobs, OPP’s and purchase orders.
• Managed budget effectively and worked well with a multifunctional team that includes value stream, purchasing, accounting, regulatory, quality, supply chain and planning.
• In charge of importing machines effectively following current US custom requirements and Biomet corporate regulations.
• Lead biweekly meetings with Biomet Warsaw, Asia Operations, JBiomet, Biomet Spain, Confidential and LX Precision in order to communicate project status, completed goals and business impact for each site.
• Also performing transfer of components from current supplier JBiomet to LX Precision.
• Participated in Kaizen activities for the standardization of our design process and customer order form improvement. Revamped current procedure for “Design of Abutments” by standardizing design and providing visual inputs for the operator to follow.
• Acquired valuable knowledge of the business and its products.
• Participated in all Global Manufacturing Engineering Team meetings and taking on the responsibility of giving continuity to all projects assigned to our team by assisting team members in their daily scope of work and allocating resources as needed.

Confidential, Dorado, PR

Senior R&D Project & Design Engineer

Responsibilities:

• Senior R&D Design Engineer for the Continuation Engineering Team providing support to all product design changes, change requests and design assurance for all BSC plants and products.
• Completed FMEA’s and design documents for the new lead molded components.
• Created an accessories kitting area for all our products as part of our tray packaging process in order to improve lead time and reduce headcount.
• In charge of the implementation of the change of DXP to DXA Eluting Drug tips and submission to FDA and all geographies.
• Managed capital projects design and manufacturing team for the redesign of new molded silicone components and Irox coated electrodes as part of the bonding process improvements made to the Heart Failure lead models.
• Project Engineering Lead for the Material Replacement Team projects dedicated to Business Continuity by re-sourcing of existing components, raw materials and suppliers in order to ensure continuous manufacturing of Cardiac Rhythm Management (CRM) products in compliance with company standards, ISO, GMP and FDA guidelines.
• Completed all Material Replacement projects on time, by managing project timelines and resources (technicians, operators, engineers and suppliers) through a tight schedule with weekly team meetings and efficient project management. Provided supervision and guidance to new team members.
• Coordinated and performed all regulatory documentation, assessments and FMEA updates for pre-market application for submission of new components and designs to FDA.
• Performed process development/characterization, statistical analysis, tolerance analysis, process validations (OQ, PQ) and capability studies of new components, for several projects such as ETFE coated wires, Medical Adhesives, Polyurethane tubing and primer replacement.
• Implemented and validated pull testing equipment & software and validated new test method for process monitoring test in order to reduce current pull test method variability. Completely eliminated scrap due to the test method variability incurring in annual savings for the company that totaled more than $200K in retesting of samples.
• Designed and implemented new fixtures, including SS molds for silicone components, on the manufacturing line to optimize lead time and facilitate operators build process.
• Responsible for the implementation of cost reduction projects throughout manufacturing lines, including the paperless manufacturing implementation with annual savings of up to $80K.
• Part of the validation team created to perform equipment and process validations (IQ, SQ, PQ, OQ) of re-layout activities for the Tachycardia manufacturing lines.
• Led problem solving exercises for other engineers, from idea conception to implementation using six sigma and lean manufacturing initiatives.
• Created Team Building activities for the team to help promote leadership and group dynamics for our employees.

Confidential, San German, PR

Manufacturing & Strategic Projects-Consulting Engineer

Responsibilities:

• Senior Engineer and supervisor for over 35 employees for the consulting firm J. Alifonso & Associates (JAA) on the Cordis site.
• In charge of interviews of new employees and new hire training for JAA.
• Part of the Strategic Projects Team performing research and development (R&D) in new product areas including drug elution and optimization of current stent manufacturing process.
• Participated in Design of Experiments (DOE) and engineering studies concerning drug elution in stent coating process using six sigma analyses.
• Provided engineering support for several product-manufacturing lines with responsibilities such as, but not limited to equipment qualification, equipment troubleshooting, performance evaluation, engineering studies and process improvement projects.
• Provided engineering support in the coordination of activities concerning new manufacturing area qualification with contractors and validation personnel and also reviewed equipment and process protocols execution.
• Provided assistance to validation processes and protocol development, plan, strategies and schedules.
• Generate, review, approve and maintain product and process documentations following the cGMP’s such as manufacturing investigations, process to hold, and maintenance requests.
• Participated in the resolution of the 483 warning letter as part of the non-conformance investigation team, responsible to identify, assess, investigate, contain, document, and implement adequate corrective/preventive actions related to non-conformances using different methodologies including Root Cause Analysis.
• Develop risk assessments and health hazard evaluations with Regulatory Compliance for unusual events impacting product discovered through material review records, to evaluate health and safety risks to patients. Worked directly with Confidential & Confidential ’s Medical Director Dr. Thomas B. Morrissey (Cardiothoracic surgeon) and in some cases additional support from Dr. Bruce Bochner the Director of the Allergy and Clinical Immunology, Johns Hopkins Asthma and Allergy Center.
• Worked in the Consent Decree resolution initiative for Chemical Plant process Investigations, Corrective and Preventive Action (CAPA), equipment and manufacturing process remediation.
• Trained in Kepner-Tregoe problem solving and Root Cause Analysis investigation method.
• In charge of investigations of the Bioconversion, Steroids and Nethilmicin plants as part of Chemical Operations compliance team.
• Performed Change Request Plans (CRP), Equipment Change Requests (ECR), Engineering and Process assessments for manufacturing, laboratory, chemical plant and utilities departments.
• Trained personnel in new procedures as part of the CAPA activities.

Confidential, Las Piedras, PR

Preventive Maintenance System Implementation-Consulting Engineer

Responsibilities:

• Developed and performed Preventive Maintenance (PM) procedures for the utilities area for over 400 equipment which included Air Handling Units, Dust collectors, Pumps, Fan/Blowers, Scrubbers, Dehumidifiers, Air Compressors, Chillers, Cooling Towers and Boilers.
• Added these PM procedures to their MP2 maintenance program and trained maintenance personnel in the performance of such PM’s.
• Created spare parts list for each equipment involved in PM revisions.

Confidential, Barceloneta, PR

Metrology Remediation-Consulting Engineer

Responsibilities:

• Instrumentation tolerance audit for over 4, 000 instruments.
• Developed Engineering Equipment Master File containing catalogs, drawings, Preventive Maintenance procedures, Spare Parts lists & specifications of Plant equipment.
• Developed and performed IQ, OQ protocols for the validation of USP system, Metal Detectors, HVAC’s, Facilities and Sampling Station.
• Performed Commissioning activities for Cooling Tower and Storage Tanks in Solvent Recovery Area.
• Performed Nitrogen Filters, Valve and Actuator assessments for chemical plant optimization plan.
• Preventive Maintenance development of pumps, Air handling Units, and Air Dryers.
• Performed Storage Area equipment inventory.
• Resident Engineer: Assisted as temporary supervisor of the chemical plant in the creation of preventive maintenance, spare parts lists, validation and commissioning of new equipment.
• Performed spare parts audit and assessment for critical chemical plant equipment which included Reactor Tanks, Vacuum Pumps, Tumble Dryers, Pin Mill and Centrifugal Pumps.
• In charge of stock room optimization and reorganization where 24-7 service was established. All critical equipment spare parts were revised and new minimum and maximum quantities were made available as was the creation of weekly reports that monitored spare part activity and financial investment.
• In charge of the maintenance and engineering departments shut down activities for the new parecoxib project.