Benjamin Duran Email & Phone Number

El Paso, Tx, Us

Draper, Utah, United States

Facilitator of a clear path to accomplish full insourcing of catheters:from early process development collaborating with R&D to the deliveryof a fully commercial production line with FDA and DEKRA submissionwith approval.

Draper, Utah, United States

Process development and depuration of critical manufacturingstations, DV execution and responsible of process validation and linestabilization for sustaining hand-off.

Program Manager for the Delivery Systems Network Portfolio andCritical Control Points effort to major production lines, implementingSPC for team selected via Kaizen, CTQ parameters.

Irvine, California, United States

For EDWARDS LIFESCIENCESSupplier Quality role for the generation of Capability Analysis and Part Qualification Traceability Matrix documentation for a different gamma of components. Analysis and generation of closurereports for part qualification process.

Guadalajara, Mexico Metropolitan Area

Protocol execution coordination, statistical analysis and report generation for pre-market tobacco application (PMTA) FDA submission at Guadalajara Mx site for Juul.

Irvine, California

- TMV Cell lead for a multi-site group (California and Israel) to develop/create/execute protocols and reports to bring up to standards a recently acquired product/company - Manage a drawing cell that process enhancements and modifications to product components - Responsible of meeting targets and deadlines in sync with project goals

Shannon, Ireland

- IQ & TFIQ lead for a consultant group fully focused on key objectives to be met in a locked schedule - Provide guidance and feedback for protocols and reports, to smooth and expedite the approval process- Strategic planning and resources allocation in order to meet objectives.

Irvine, California

- TMV Cell lead for a multi-site group (California and Israel) to develop/create/execute protocols and reports to bring up to standards a recently acquired product/company- Manage a drawing cell that process enhancements and modifications to product components- Responsible of meeting targets and deadlines in sync with project goals

Irvine, California

- Key member for the Real time aging testing group to identify the gaps from different families and subfamilies and address them. - Generate and execute Design Verification protocols and reports for different product families to achieve DEKRA recertification.- Perform analysis to generate bracketing strategies and simplify the testing portion of the protocols

Draper, Utah

- Responsible of update and align DFMEA and PFMEA for several product families. - Work with R&D engineers, Manufacturing engineers to clearly define the gaps that are required to be addressed and implement the required changes

Anasco, Pr | Irvine, Ca | Sto. Domingo, Dr

Installation Qualification Validation Lead for Puerto Rico site:- Responsible for the Lean implementation of the IQ Cell- In charge of planning, reporting and generation the weekly progress dashboard- Key member for the implementation and execution of remediation project TFIQ/IQ/TMV Cell Implementation for Irvine CA site- In charge of planning, reporting and implementation of the lean validation cells- Responsible of the weekly reporting and plan adherenceOQ/PQ Cell Implementation for Sto. Domingo, DR site- In charge of planning, reporting and implementation of the lean validation cells- Responsible of the weekly reporting and plan adherence

Draper, Utah

Responsible of managing the IQ/OQ team, a group of eight (8) engineers that was responsible to complete in a timely manner the creation, execution and report approval for all IQ/OQ protocols. Leverage with Operations team to access the equipment without impacting production schedule for the protocol executions. - Perform gap analysis to existing protocols to address gaps accordingly and provide accurate estimations - Strategize and create schedule for the different phases of the project- Provide updates on a daily basis to maintaining the team working according to schedule

El Paso, Texas Area

Responsible of leading validation efforts for manufacturing equipment, guiding engineering interns to manage the validation process and to use current Good Manufacturing Practices (cGMP), all projects were tracked by a Gantt chart with a periodic review of activities, keeping special importance on the critical path in each case. NPI Support Engineer, link between R&D and Manufacturing to launch a new product. During this timeframe I’ve been managing validations for packaging equipment and fill and seal equipment to manufacture glass vials. Also, developing and implementing new procedures to manufacture a new product; developing parameters, creating and executing analysis to manufacture samples for marketing to be tested in clinical trials.- Risk Assessment, Change Control & Quality Impact Assessment- Validation Plan (Gantt Chart) & Process Validation (IQ-OQ-PQ-PPQ)

Cd. Juarez, Mexico

Support Production Line- Full support to daily manufacturing requirements, equipment (ultrasonic welders, leak testers and packaging machines) and address quality issues - Responsible for manufacturing procedures, BOMs, Routes and documentation forms - Responsible for corrective/preventive actions required from Internal/External Audit or CAPAsStay in Business Projects- Projects Type: Design Change / Raw Material Qualification / Supplier Changes and CIPs. - Generate and Execute Process Validation Protocols (MVP, IQ, OQ, PQ)- Generate and Execute Product Qualification (Stability Testing, Ship Testing, etc.)- Engineering Runs (DOE, Edge of Failure, Gauge R&R Study)

Cd. Juarez, Mexico

Validation Strategies- Writing Medical Device - Validation Documents (Technical Assessments, Technical Reports, Validation Plans)- Project Timelines development for Transfer &Validation activities- Highly experienced on Equipment/Process TransfersValidation Documentation- Creation and approval of validation protocols and reports (SAT, FAT, IQ, CSV, OQ, PQ) and decision making key player during each validation stage- Project Leader for Validation Engineers, accountable to achieve project planning and deliver on-time results

Cd. Juarez, Mexico

Responsible for Validation Activities- Provide solutions with new designs, modifications and validation activities- Responsible for equipment installation and creation of maintenance plans- Provide Completion report for validation activities- Coordinate personnel, leverage equipment availability, handle raw materials, provide training and make sure that all protocols are successfully executed

Cd. Juarez, Mexico

Provide support to Manufacturing Process Medical Devices- Root cause analysis for non-conformances.- Packaging Support for Sterility Barrier (Multivac Form Fill and Seal Machines)- Electro-Mechanical problems solving- Corrective Action proposal and implementations- Lead Electromechanic technicians for effective and quick solutions