Luis Davila Email and Phone Number

Led cross-functional Core Teams, managing project risk and stakeholder expectations for EU MDR submissions. Utilized MS Project, Smartsheet, Excel, and Prochain to drive process improvements and ensure timely delivery of new and existing products and services following PMI best practices and Agile concepts. Collaborated with PMO and Regulatory leadership to ensure compliance and process optimization.

Genetics: Developed strategic negotiations with current contract customers, addressing CX&E challenges. Collaborated closely with the Business Development Director, utilizing Smartsheets to track progress and provide weekly updates. Served as a liaison between customers and Ambry, ensuring seamless communication and driving business growth.

MEDICAL DEVICES: Spearheaded projects from initiation to delivery, ensuring timely, within-budget, and within-scope execution. Led and directed Quality Project execution plans, overseeing all aspects of projects and Corrective Actions and Preventive Actions (CAPAs). Coordinated and controlled project timelines, resource allocation, and progress monitoring, utilizing MS Project, Smartsheet, Excel, and SAP to drive efficiency and compliance. Collaborated hand-in-hand with Regulatory leadership to ensure seamless implementation of ISO 13485 and ISO 17025 international standards, maintaining compliance while meeting customer requirements. Continuously improved processes, ensuring alignment with industry standards and best practices.

▪ PHARMA: Provided strategic guidance for implementing contracts at MMD site, deploying advanced endpoint technology (Cylance, Cisco AMP) globally. Managed cross-matrixed teams, coordinating internal resources and vendors to deliver projects on-time, within scope, and within budget. Utilized MS Project, Smartsheet, Excel, and SAP to drive project execution, ensuring flawless planning and coordination. Collaborated with Regulatory leadership to ensure compliance and process optimization. Supported MES implementation, including URS, Design Review, and Risk Management, ensuring seamless integration with ERP Systems and PLCs.

▪BIOPHARM: Supported cross-functional teams in specifying, developing, and managing projects across administrative, technical, and scientific domains. Leveraged medical device compliance knowledge, design expertise, and technical guidance to lead and contribute to innovative medical device development. Identified and mitigated project risks, implemented workshare structures, and ensured clear communication with global teams to facilitate manufacturing procedure development, test planning, and troubleshooting.

▪MEDICAL DEVICES: Project Manager and Process Engineer, who spearheaded process design and implementation, driving efficiency, cost-effectiveness, and sustainability to boost profitability. I introduced new electromechanical and disposable medical devices, formulated project plans, and oversaw comprehensive training programs. My role also encompassed process simulations, constraint management, risk assessments, and process documentation. As an Operational Excellence Leader, I enhanced product quality and streamlined operations.

▪OTC: Integration Project Manager responsible for ensuring complete adherence to CGMP and Quality Compliance. Plans and directs activities related to the design and development of products and protective packaging containers. Improve Operational Efficiency with a 45% reduction in manufacturing by integrating an existing ERP System to New MES platform.

▪ MEDICAL DEVICES: Manage and execute projects related to new product introduction, product transfer, procurement, and process/product improvements for Single Use Technologies. This includes managing projects from concept to delivery, ensuring timely and within-budget completion. ▪ Prepare and maintain documentation, including project status reports, updates, audits, engineering reports, data summaries, project schedules, and quality certifications. Additionally, I monitor product development using SAP systems and global planning systems, and design products using Inventor software (3D CAD) for Single Use Technologies.

▪OSD: Validation Project Manager supervised validation project, update schedules, and maintain communication within the team through minutes, and 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 for supporting and correcting CSV, CIP, HVAC, and WFI protocols activities for product specification and validation process as well as implementing 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 site build/commissioning.

▪OSD: Transfer Project Manager accountable for planning and execution of manufacturing plant transitions, including transfer of pharmaceutical products, process, equipment, and validated controls. Verify execution control for projects.▪Coordinate project team meetings (Travel from Puerto Rico to Ascoli 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.

▪MEDICAL DEVICES: Manufacturing Engineer responsible for implementing and defining the user requirements (URS) for Machine 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.▪Development and maintenance of Design Transfer SOP’s to ensure device design comply and is approved, verified and validate before Production Process. Designed and assembled system with Becton Dickinson (BD) Baltimore USA, main component supply by Cognex Corporation.

▪PROJECT DEVELOPMENT MANAGER: manages, lead and organize company operations, marketing efforts, recruitment of talent, and oversee project execution of personnel at different client sites.▪Project Manager (Pfizer PR): Responsible for leading cross-functional team s in the development and implementation of new products or transfers and ERP platform s. 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 program s 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.▪Experienced Accounts Receivable Manager: Proficient in overseeing the entire accounts receivable process. Skilled at monitoring outstanding invoices, ensuring timely payments from customers or clients, and maintaining a healthy cash flow. My expertise includes accurate forecasting, and optimizing resource allocation.

▪PARENTERAL: Project Manager (GlaxoSmithKline): responsible for scheduling meetings of contractors and inspectors, supervising site and construction management, collecting requirements (with project charter), and defining the scope to generate the 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 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.▪Construction Project Manager (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 flushing, blowing, dry-out, box-up, Leak testing, construction liaison, purging, cold circulation, etc.), site build/ commissioning, and start-up assistance for a new building, equipment, and facilities.▪Wrote, Revise and Approved Product Design, Capital Expenditures, PO, SOPs, IOQ, PQ, FAT, CAPA, NCR, and POR. Develop and maintenance of Design Transfer SOPs to ensure device design is in accordance with the production plan, ISO 13485, and IEC6601.▪Manage Chemistry Manufacturing Controls (CMC) from drug product manufacturing technologies, initiation, and Management.

Engineering Designer, Created engineering design and installation drawings. Handled and resolved problems and developed design. Generated complex 3D models and drawings that meet quality and content requirements; developed design configurations. Developed layouts incorporating modified concepts in engineered installation drawings and sketches. Prepared layouts for complete apparatus characterized by critical electrical, mechanical, and piping clearances. Performed all design tasks in accordance with Quality Assurance Program requirements. Responsible for process improvements, support of the manufacturing floor, development of preventive maintenance schedules for manufacturing equipment, creation and maintenance of routings of products, quotes for new products, customer interface for customer satisfaction. Prepared manufacturing process plant layout, piping plan, isometric design, piping as built and cost estimates on plant site.Provided technical solutions for a wide range of difficult design problems. Developed Assembly models, component models, layouts, sketches and drawings. Investigated design factors such as tolerance stack up, damage tolerance, durability, and structural modeling. Validated conformity to design standards and specifications. Identified design errors and other deficiencies, and recommended changes.

▪Design Engineer (Patheon PR): Manage design, development, testing, process and validation of automation lines. Performed cost estimate preparation by utilizing Cost Work software as 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.▪Bristol-Myers Squibb (Devens, MA): Oversee all aspects of construction projects with full responsibility for completing and modify construction drawings on time while maintain quality and safety standards.▪Manage Chemistry Manufacturing Controls (CMC) from drug product manufacturing technologies, initiation and Management