- Over 20 years of hands on experience in pharmaceutical and medical devices in FDA regulated environment with expertise in the following:
- Floor support and day to day operations, creation of procedures, inspection plans, Non - conformance investigations, Corrective/Preventive Actions (CAPA), supplier qualifications, continuous improvement projects, cost savings and cost reductions projects, change management, statistical analysis, Gage R&R, trained in six sigma black belt, root cause analysis and DMAIC methodologies.
- Project Management, timeline and schedule of activities, coordination with multiple departments, supplier audits, ensure timeline is met. Perform testing or equipment and process validations as required for Quality or Manufacturing Engineering. Ensure continuous supply chain while transfers are moved into production. Creation and characterization of new manufacturing processes and inspections. Determination and review of manufacturing drawings, specifications and limits. Post Market Review Analysis for manufacturing and quality departments.
- Created Global Validations systems for Confidential & Confidential and Confidential including policies, procedures, protocols, reports templates, deviation forms, for process (IQ/OQ/PQ) and Test Method Validations. Wrote, reviewed and executed more than 100 validations for Equipment, Processes, Packaging, Cleaning, TMV, utilities and facilities during my career.
- Highly experienced in leading, establishing and executing plans for Regulatory and Quality Compliance remediation projects. Developed Compliance Master Plans for FDA observations in different companies. Participated as Process Validation expert and Engineering Manager in FDA Audits. Worked on resolution of Confidential and 483 warning letters. Created CAPA and Non-conformance systems to comply with FDA requirements and improved to reduce cost of quality. Defined product and patient risk in Risk Management standards according to ISO 14971. Created FMEA procedures and templates. Worked on Class 1, 2 and 3 devices. Completed engineering requirements sections for regulatory submissions.
- Experienced Manufacturing Engineering Manager in charge of 10 engineers and 4 technicians with global responsibilities, responsible for Sustaining Engineering, Day to Day floor support (non-conformances etc.), New Product Development projects, Equipment and process validation, continuous improvement and cost saving projects, Product and Process Transfers and Engineering CAPA’s. As a consultant managed 25 engineers, made sure all employees were completing project milestones on time, met with clients to ensure expectations were being met.
- Complaint investigation associated to manufacturing and quality systems. Reviewed Post Market surveillance reports and supported actions required to improve product performance.
- Working experience with machining processes, chemical processing equipment (anodizing, cleaning, polishing, surface finishing etc.), laser marking, molding, packaging and inspection equipment used for metal implants.
Excellent communication and leadership skills
Teamwork oriented, quick learner and self-starter.
Fully Bilingual (English and Spanish).
Oracle, 3Shape, Microsoft Office Word, Excel, Power Point, Project, Trackwise, MP2, Cal Pro, AutoCad, Minitab, Maximo, Windchill, cPDM.
Confidential, Palm Beach Gardens, FL
Senior Quality Engineer
- Responsible for Test Method Validation (TMV) remediation of current test methods and creation of a global validation system.
- Provided compliance assessment of current Test Method Validation (TMV) System, procedures and practices and contributed to the development of new architecture including creation of policy, procedures, templates, protocols, reports, for the Global Confidential organization (US, Europe, China).
- Developed training material and provided training for the roll out of new global Test Method Validation system, including statistical analysis (gage R&R) and requirements for sampling.
- Worked remotely with US and international (China and Europe) sites on a weekly basis to establish milestones, report on goals and accomplishments.
- Wrote protocols and reports and executed test method validations for electromechanical products (drills, motors, attachments etc.) and their existing test methods which included dimensional, visual inspections, in - process and functional tests used to release product.
- Created and standardized visual standards and procedures to perform the test methods.
- Analyzed drawings and design specifications to make sure that requirements were established, tested and met for required devices.
- Worked on process improvements by writing and updating manufacturing process and inspection procedures for assembly and repair of machined and electronic components.
- Worked on investigation and resolution of CAPA s related to the Test Method Validation remediation project.
Confidential, Palm Beach Gardens, FL
Global Concurrent Manufacturing Engineering Manager
- In charge of Manufacturing Engineering team responsible for product transfers and new product development and introduction (NPI) to operations in addition to sustaining engineering for the Palm Beach Gardens FL site.
- Successfully managed projects and team members to complete 20 NPI projects involving global responsibilities for Biomet Dental facilities in Palm Beach Gardens, Florida and Valencia, Spain.
- New product introduction projects included product transfers from suppliers, transfers from site to site, creation of new products (processes) and distributed by products. In addition to introduction of new equipment and technologies such as chemical cleaning processes, bead blasting for roughened surface metals and 3D printing for rapid prototyping.
- Created Manufacturing Plans detailing manufacturing engineering responsibilities and deliverables based on design requirements in order to complete successful and compliant new product introductions and transfers into production.
- Created product based PFMEA templates and procedure as part of the Risk Management team.
- Reviewed and approved documentation regarding new product development process such as design & development plans, design input/output traceability matrix, design specifications, drawings, risk assessments, hazard analysis, process flow charts and post market surveillance review.
- Wrote, reviewed and approved manufacturing and quality procedures related to machining, chemical processing, cleaning, laser marking, packaging, sterilization and QA inspections through change control process and performed periodic reviews.
- Provided constant local and global support in the problem solving, root cause analysis of CAPA’s and complaint investigations related to manufacturing operations and engineering for both the Palm Beach Gardens, FL and Valencia, Spain manufacturing facilities.
- Wrote, reviewed and approved CAPA’s and Non-Conformances as part of the CAPA Board and completed CAPA’s related to Equipment/Process Validation, improvements to the CAPA system, Design Controls, Risk Management, engineering improvements, design transfers into production.
- Monitored completion of CAPA’s for the engineering team.
- Implemented investigation tools in the CAPA procedures to improve the root cause analysis process such as 5-why, is-is not, and Ishikawa (fishbone) diagrams.
- Used Six Sigma, DMAIC, Kaizen, poke yoke, fishbone diagrams, 5 why and other root cause tools to identify solutions to issues identified through Non-conformances and CAPA’s on the manufacturing floor. Provided guidance to engineers as needed in problem solving activities.
- Performed Supplier Tech reviews and supplier quality reviews for new suppliers.
- Performed engineering studies to support cost savings projects by improving cycle time, improving tolerances, decreasing setup times, inspections and sample sizes.
- Created KPI’s for manufacturing operations (safety, on time delivery, cycle time) including quality operations (Non-Conformance, CAPA’s, rejects, reprocess etc.).
- Supported Value Stream Manufacturing Engineering on sustaining and improvement projects as well as provided pilot cell and engineering resources for completion of these activities.
- Supported and participated in the creation of a Compliance Master Plan (CMP) due to FDA 483 observations for the FDA Readiness, CAPA, Production and Process Controls, Design Controls, and Risk Management work streams.
- Completed gap analysis for compliance to ISO 13485, FDA Regulations Part 820 and GHTF for validation and process controls and aligned all sites.
- 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.
- Participated in the DHF remediation as part of the Design Controls team.
- Completed FDA responses and improvements needed for FDA observations (CAPA, Design controls and Process Validation) effectively and on time.
- Led efforts on remediation projects in Valencia for validation of cleaning processes and water system improvements. Made sure validations were compliant to quality standards and regulations.
- Completed successful BSI Audit in May 2014 as the process and equipment validation expert.
- Managed budget effectively and worked well with other multifunctional teams (marketing, supply chain, regulatory etc.).
Confidential, Palm Beach Gardens, FL
Product Transfer Manufacturing Engineer
- 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.
- 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.
- 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
- 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
- Senior Engineer and supervisor for over 35 employees for the consulting firm J. Alifonso & Associates ( Confidential ) on the Confidential site.
- In charge of interviews of new employees and new hire training for Confidential .
- 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.
- Led CAPA and Non-conformance investigations team, wrote investigation reports, implemented solutions and reviewed other team members non-conformances.
- 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.
Confidential, Manati, PR
CAPA and NC Remediation-Consulting Engineer
- Worked in the Confidential 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
- 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, Arecibo, PR
- Validation of the Nitrogen System: performed sampling and OQ execution.
Confidential, Manati, PR
- Developed and performed IQ for Sampling Station in Confidential warehouse.
Confidential, Barceloneta, PR
Metrology Remediation-Consulting Engineer
- 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.