Luis_Davila_Resume

Luis Antonio DavilaProject Manager / Manufacturing Professional Arlington TX 76006 [email protected] (787) 605-8643

● DEVICE DESIGN ● OPERATIONS ● PRODUCT ENGINEERING ● QUALITY ● COMMISSIONING

Professional Profile

An enthusiastic Pharmaceutical, Medical Devices, Manufacturing and Regulated Industry professional, committed to help and improve Operations, Compliance and Project Management environment at business, engineering, and technology corporations. I am eager about helping my clients move mountains in their process improvement search, transfer technologies and implementation of new projects. Detail-oriented professional with an extensive background in process, product engineering and management, complemented by many years of hands-on experience in fast-paced settings and challenging environments. Organizes and leads matrixes project team as per required by stakeholders, managed project budgets from $2M to $25M. Responsible for the continued development and implementation of the process functions for various companies in New York, Baltimore, Michigan, Ascoli (Italy) and Ilfracombe (England) responsibilities include but are not limited to the development, engineering and administration of all feasibility, methodologies, pilot plant testing and manufacture procedures related to the development of new products.

ISO 13485, IEC 60601, and 21CFR 211, 820,821 Technology Transfer Management, Capex and Opex Budget Management, Project Charter, Project

Plan, Plan Risk Management, Project Resources Management, Design of Experiments, CAPA, Project Management / Agile (Scrum), Engineering Assessment, CSV, Utilities and Equipment Validation, Extractables and Leachables MOC, ERP, SAP, MS Excel, MS World, MS Project,

BOM, Minitab and AutoCAD Inventor 3D

Equipment/System ExpertiseBag Sealer Automated Dispensing Systems

Vision Inspection Cell Reverse Osmosis SystemFluid Bed Granulator Tablet Coater

Fluid Bed Dryer High Speed Tablet PressesTubing Cutter Tube Sealer

Oetiker Clamp Pincer Solvent DispenserThermo Plastic Extruder Texture Analyzer

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Professional Experience

SWISS AMERICAN CDMO, ONBORADING PROJECT MANAGER, October 2015 – PRESENT OTC: Develops, program and confirm strategic negotiations with current contract customer accounts by

researching and resolving customer challenges, review day-to-day operations relating to customer demand providing required internal information as a liaison between contract manufacturing customer and operations, working in tandem with Quality Engineer Manager. Responsible and accountable to complete the contract customer’s product commercialization process.

Played rack product development from research to implementation of finished goods. Maintain current information in manufacturing system. Provide weekly updates to commercialization team for all active projects. Develops the product strategy and roadmap for the customer. Interface with operations and supply chain to ensure product shipment meets the SAP SOTIF standard.

PALL LIFE SCIENCES, SR. PRODUCT ENGINEER / PM, October 2013 – July 2015 Medical Devices: Management and execution of manufacturing, engineering and validation projects

related to new product introduction, inter-company product transfer and procurement as well as process and product improvements on existing product lines for Single Use Technologies.

Played key role in $20M project slated to improve operational efficiency, with 45% reduction in manufacturing lead times and expected $5M annual savings. Organize and lead teams to accomplish desired results in terms of design feasibility for plastics (resins) medical products and manufacturing lead time response.

Prepare and maintain documentation by doing periodic project status reports, project updates, audits, engineering reports, data summaries, project schedules and quality certifications as well as extractables and leachables MOC. Monitoring product development by means of using SAP systems and global planning systems, evaluations and design of products with Inventor software (3D CAD) for Single Use Technologies.

Wrote, Revise and Approved Product Design, Capital Expenditures, PO, SOPs, IOQ, PQ, FAT, CAPA, NCR and POR. Develop and maintenance of Design Transfer SOP’s to ensure device design is in accordance with production plan, ISO 13485 and IEC6601.

Project Manager and key point of contact for assigned programs related to Global Quality initiatives. Develop scorecards for program implementation status; define and report metrics on program progress, implementation and effectiveness; responsible for management reporting for the implementation of unique device identifier (UDI).

Develops injection-molding machines SOP, IQ, OQ, PQ, and MSA to cast products from thermoplastic materials. Sets machine controls, regulating molding temperature, volume of plastic, molding pressure & time, according to knowledge of plastics molding procedures

PROCTOR & GAMBLE, (VALIDATION & ENGINEERING GROUP), MANUFACTURING ENGINEER, April 2013 – October 2013 API: Manufacturing Engineer supporting projects execution for multiple Cleaning and Utilities

validation activities, IQ, OQ, PQ, FAT, MSA, Interims Reports, CAPA, Completion Reports, and provided project status reports for communication with site management.

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NOVARTIS, (VALIDATION & ENGINEERING GROUP), PROJECT MANAGER, October 2012 – April 2013 OSD: Validation Project Manager supervised validation project, update schedules, and maintain

communication within the team through minutes, timelines. Authored and audited equipment, test methods and Part 11 compliance documentation and processes.

Coordinated and managed cross-functional teams and validation project activities to meet project milestones and provide deliverables within budget and on schedule.

Responsible of support and correct CSV, CIP, HVAC, and WFI protocols activities for product specification and validation process as well as implement new computerized systems to meet system quality. Collaborate with Q.A in writing and executing master formulas in support of batch improvement.

Prepared and executed validation documentation including: commissioning and qualification protocols for facility, utility and equipment systems; validation protocols for cleaning and shipping validation; protocol deviations; risk assessments and reports.

PFIZER, (ALPHARMA SOLUTIONS), TRANSFER PROJECT MANAGER, April 2012 – October 2012 OSD: Transfer Project Manager Proficient in planning and execution of manufacturing plan transitions,

including transfer of pharmaceutical products, process, equipment, and validated controls. Managed, budget and execution control for projects.

Coordinate project team meetings (Travel from Puerto Rico to Ascoli Piceno Italy and Kalamazoo Michigan for scheduling, agenda preparation, material preparation, facility inspection, etc.).

Adopt LEAN and Value Stream principles to evaluate current processes and practices to design stream lined alternatives. Provided project status reports for communication with site management.

BECTON & DICKINSON, (ALPHARMA SOLUTIONS), MANUFACTURING ENGINEER / PROJECT MANAGER, January 2012 – April 2012 Medical Devices: Manufacturing Engineer responsible for implementing and defining the user

requirements (URS) for Vision System (Sensor Inspection Cell). Manage project deliverables and milestones, including personnel and resource allocation travel from

Puerto Rico to Baltimore USA. Manage by means of Agile methodologies project scope, software development, and timelines.

Responsibilities include but are not limited to protocols generation and execution of Engineering Assessment, Installation Qualification, Measurement System Analysis (MSA), Operational Qualification, and Performance Qualification.

Development and maintenance of Design Transfer SOP’s to ensure device design comply and is approved, verified and validate before Production Process. Evaluated, specified and recommended new equipment, data collection and process automation for the site. Designed and assembled system with Becton Dickinson (BD) Baltimore USA, main component supply by Cognex Corporation.

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APG CORP, PROJECT DEVELOPMENT MANAGER, January 2004 – January 2012 Project Development Manager manages, lead and organize company operations, marketing efforts,

recruitment of talent, and oversee project execution of personnel at different client sites. Manufacturing Engineer (Becton & Dickinson PR): Responsible for designing and developing new

products and products to enhance existing product line in conjunction with Product Marketing. Performs various activities, including selection of materials, form, fit and function, design failure mode effect analysis, and design reliability testing. Conduct capability analysis (cPK studies) and pFMEAs. Supervised Process Validation activities for Medical Device Compliance and Packaging and Utilities validation activities, IQ, OQ, PQ, FAT, MSA, and Interims Reports. Work and execute Engineering Assessment for CNC machine tooling room, and wrote the CNC machine SOP.

Project Manager (Pfizer PR): Responsible for leading cross-functional teams in the development and implementation of new products or transfers and ERP platforms. Execute and write-up process of Computer System Validation. Project manager, by means of Agile methodology for development of small software applications to integrate ERP system with manufacturing floor, as per assigned programs related to Global Quality initiatives.

Packaging Engineer (Bristol-Myers Squibb PR): Responsible for direct activities concerned with the design, prototyping, testing and delivery of containers for partial processed raw material. Includes design reviews, 1st article inspections, laboratory (vibration, impact, compression, etc.) testing, and troubleshooting. Authored and executed package test method validation protocols and package test method transfer protocols.

Construction Project Manager (Bristol Myers Squibb PR - Millipore USA): Development of Capex Budget and cost performance baseline for project funding requirements. Initiation, Planning, Execution, Monitoring And Controlling, and Closing. Value key player to establish Project Cost Management methodologies for scope baseline, project schedule and human resources plan to determine cost performance baseline and project funding requirements. Commissioning Project Manager for Millipore expansion of its Drug Discovery and Development facility in St. Charles, Missouri. Responsible for onsite engineering and pre-commissioning of production pipelines (as like flushing, blowing, dry-out, box-up, Leak testing, construction liaison, Inerting, purging, cold circulation etc.. ), commissioning and start-up assistance for new building, equipment’s and facilities.

ISS CORP, PROJECT MANAGER, January 2001 – January 2004 PARENTERAL: Project Manager (GlaxoSmithKline): responsible for scheduling meetings of

contractors and inspectors, supervising site and construction management, collect requirements (with project charter), define scope to generate project scope statement. Perform quality assurance by using project plan and quality metrics, thus generating plan updates

Validation Technician (Merck PR): Technical writing and execution of protocols (IQ,OQ,PQ,FAT,DQ) for Utilities Systems such as Nitrogen, Soft Water, Heat Transfer Package and Compressed Air. Recommended equipment, material, and packaging design modifications to resolve packaging issues, leading to an increase in efficiency and decrease in turnover.

Manufacturing Engineer (Merck PR): Monitoring of QA activities for all process critical components/interfaces. Demonstrated expertise in manufacturing and production quality processes, serving as consulting representative on company’s Lean/Six-Sigma initiatives. Performed GAP analysis on validation packages for automated clinical chemistry and immunoassay analyzers.

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LOCKWOOD GREENE, PROJECT MANAGER, January 1997 – January 2001 Construction Manager (BMS USA): Oversee all aspects of projects with full responsibility for

completing construction on time while maintain quality and safety standards at BMS. Supervisory responsibility in most areas, including field engineering, project control, administration of contracts and subcontracts, field superintendence, safety, labor relations develops a deliverables schedule to provide a road map for the construction team, reviews the contractual conditions of performance. In charge of the project budget for materials and manpower & maintaining accurate billing records

Design Engineer (Patheon PR): Manage design, development, testing, procurement and validation of automation packaging. Includes steel shipping racks, custom and standard returnable containers, and expendable containers, for both domestic and international applications. Performed cost estimate preparation by utilizing Cost Work software and main working tool. Generated complex 3D models and drawings that meet quality and content requirements of manufacturing floor; developed design configurations for CNC machine project tooling room.

EDUCATION Master Degree Project Management, Keller Graduate School Of Management BS Technical Management, DeVry University BS Mechanical Engineering, Polytechnic University Of Puerto Rico

TRAINING Advanced Program Management Finance: Managerial Analysis Master Planning and Operational Strategy Material Requirements Planning and Capacity Applied Managerial Statistics CSV Life Cycle Documentation CSV IQ, OQ Typical Test Project Risk Management Facilities & Utilities Qualification Project Quality Management Project Management / Agile (Scrum)

CERTIFICATIONS General Industry Safety & Health U.S.- Department of Labor OSHA Num. 700-138111

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