Experience

Validation & Engineering Group, Inc.

• Puerto Rico
• Engineering Services
• 1 - 100 Employee

• Senior Validation Engineer

  • Mar 2021 - Present



Escalate Sciences

• United States
• Research Services
• 1 - 100 Employee

• Commissioning Validation Specialist

  • Aug 2020 - Mar 2021

  Provide support as a contractor for Moderna ● Supplier Protocol assessments ●User Requirements Specifications (URS) ●Design Qualifications (DQ) ● Requalification ● Factory Acceptance Tests (FAT) ● SAT Site Acceptance Testing ● CQV Commissioning and qualification Installation ● Provide Support to Quality System record assessments, root cause investigations and actions (Change Controls, Deviations) ●Provide Support to Internal and External Audits ● Provide Validation Support for any new equipment and changes to existing equipment ● Maintain Validation Master Plan documents and schedules. ● Periodic Review. Show less



Weil Group, Inc

• Puerto Rico
• Outsourcing and Offshoring Consulting
• 1 - 100 Employee

• Manufacturing Engineer

  • May 2018 - Aug 2020

  ● Key contributor in FDA Warning Letter Remediation Team. Qualification and Validation activities to accomplished FDA observations. Lead the implementation of new manufacturing processes, systems to save more that 2 million dollars in product. Lead the implementation of a new (Bioburden and Endotoxin) process and monitoring program for all the business unit models and products. Lead the implementation of a new bill of material (BOM) change. Lead multiple (MES) implementation. Accountabilities: Track activities; Reporting; validation protocols testing; work plans; process design and development; engineering studies; data analysis; instruction-level documents and final reports.● Process Validation (PV) ● Computer Systems Validation (CSV) ● Equipment Qualification ● Installation Qualification Reports (IQR) ● Regulatory Compliance ● 21 CFR Part 11● Change Control ● Staff Training ● Documentation & Reporting ● Operational Qualification (OQ) ● Performance Qualification (PQ) ● Process Characterization (PC) ● cGMP’s, PODs, Work Instruction (WI) & SOP ●Kaizen ● System Requirement Specifications (SRS)● Validation Change Management (VCM) ● Design Specifications (DS) ● Source Code Review ● Statistical Process Control (SPC) ● Process Planning Matrix (PPM) ● Impact Risk Assessment (IRA) ● CAPA Process Control Effectiveness ● Relative Humidity and Pressure Environmental Control (CEA) ● Engineering Technical Report (ETR) ● Process Failure Mode Analysis (PFMEA) ● Risk Assessment (RA) Show less



T-Mobile

• United States
• Telecommunications
• 700 & Above Employee

• Retail Sales Associate

  • Nov 2010 - Nov 2017

  ●Proactively acknowledge, greet and assist customers in the store. Merchandised, stocked and replenished the selling floor constantly. Inventory management, meet and exceed sales goals. Train coworkers and manage business account and accomplish Business Account SME goals. ● Support Field Service Technicians and track all Cell Sites activities. Audit and make economic report. Contribute to the selection of power generators for the sites and other facilities. ●Proactively acknowledge, greet and assist customers in the store. Merchandised, stocked and replenished the selling floor constantly. Inventory management, meet and exceed sales goals. Train coworkers and manage business account and accomplish Business Account SME goals. ● Support Field Service Technicians and track all Cell Sites activities. Audit and make economic report. Contribute to the selection of power generators for the sites and other facilities.