Nelson Ithier Email & Phone Number

Puerto Rico

Assigned to Baxter Healthcare Aibonito as Validation Consultant. Performed Design Qualification (DQ), Installation Qualification (IQ) and Software Validation (SV) of a FANUC Roboshot a-S300iA Automatic Injection Molding machine. Performed Operational Qualification (OQ) and Performance Qualification (PQ) of a CTS Blackbelt Pro Restrained Pressure Decay test machine for business continuation. Performed joint assessment with Molding Product Design SME resulting in an economic impact of $7.3K through scrap prevention.

Juncos, Puerto Rico

: Assigned to Amgen Manufacturing Limited at Juncos, PR as a Process Development Scientist. Provided process development commercial support to syringe inspection lines 546 and 4120. Conducted feasibility studies in inspection lines 546 and 4120 to improve automatic inspection machine setup. Collaborated in the testing and implementation of optimized vision files for stations C4, C5, C05 and C8 on product recipes for Repatha, Enbrel, Amgevita, Aimovig, and Dmab HC. Conducted manual visual inspection method confirmation for COMAB (AMG-309) 20r vials. Performed Site Acceptance Test (SAT) of portable manual inspection booths for inspection of AMG-309 and ABP 938 product.

Humacao, Puerto Rico

Assigned to Becton Dickinson Interventional at Humacao, PR as a Supplier Quality Engineer for new product launch project. Responsible for verification and approval of supplier process qualification documents for new components. Responsible for assuring that supplier qualification documentation complies with Becton Dickinson Puerto Rico Quality System requirements and regulatory requirements. Responsible for issuing Supplier Quality Alerts and conducting Material Review Report investigations for non-conforming manufacturing components.

Arroyo, Puerto Rico

Ensure compliance with regulatory related requirements for supplier components. Provide support to Quality internal audit activities. Design and implement methods and procedures for inspecting, testing, and evaluating the precision and reliability of components and/or test equipment. Validate supplier processes and products including current products and tool transfers. Analyze reports and/or returned components and recommends corrective action. Follow up suppliers’ response and implementation of corrective actions. Implement effective process controls at supplier’s facilities and or Stryker Puerto Rico. Verify completeness of specifications of suppliers’ products and or processes. Provide engineering interface with suppliers.

Dorado, Puerto Rico

Assigned to Stryker Puerto Rico in Arroyo, PR as a New Product Engineer. Responsible for manufacturing process development, manufacturing line setup, risk analysis, equipment and process validation for new products. Successfully launched a new all-suture anchor product line within a six-month deadline period.

Villalba, Puerto Rico

Manufacturing process owner responsible for troubleshooting, productivity improvement project development and implementation and support to product manufacturing lines and parts cleaning area. Technology specialist for cold molding processes responsible for installation and qualification of molding equipment, developing and performing DOE for molding processes.

Ponce, Puerto Rico

Responsible for CNC machine turnkey development, tooling selection, development and maintenance of ultrasonic cleaning, electrocleaning, electropolishing and passivation processes for each assigned product line in the Trauma business unit. Also, responsible for manufacturing personnel training, troubleshooting, productivity improvement project development and implementation, process capability studies, process capacity studies and support to manufacturing cells including non-conformance corrective action applicable to a regulated manufacturing environment. Capital acquisition project manager responsible for model selection, proposal documentation, purchase requisition submittal, factory acceptance testing, installation, spare parts list, preventive maintenance schedule, qualification (IQ/OQ), first article, manufacturing procedure development and personnel training of new equipment; Performed process qualification (PQ) for processes with new manufacturing materials and/or parameters.

Ponce, Puerto Rico

Process owner for various data storage and management product lines; Provided support by troubleshooting problems, maintaining production flow continuity. Assisted inspections by safety agency representatives from UL, CSA and TÜV Rhineland and implemented corrective action solutions in the event of a process variation.

San Juan, Puerto Rico

Performed preventive and corrective maintenance on marine diesel engines, reduction gear and vessel auxiliary systems; Participated in maritime law enforcement and search and rescue exercises and operations.