Experience

Validation & Engineering Group, Inc.

• Puerto Rico
• Engineering Services
• 1 - 100 Employee

• Senior Validation Consultant

  • 2022 - Present

  Completed the validation for the site Nitrogen gas utility. Developed the Validation documents for the site liquid Nitrogen utility. Developed and executed addendum protocol qualifications for cleanrooms. Executed the smoke studies and PQ for cleanrooms and supporting areas. Completed the validation for the site Nitrogen gas utility. Developed the Validation documents for the site liquid Nitrogen utility. Developed and executed addendum protocol qualifications for cleanrooms. Executed the smoke studies and PQ for cleanrooms and supporting areas.



American Laboratories (ALI)

• United States

• Quality System Manager

  • 2019 - 2021

  Oversee and support the process of change control approval from evaluation of an initial proposal, through approval, implementation, closure, and effectiveness review. Effectively collaborate cross-functionally to facilitate the completion of documents. Verify the completeness and correctness of supporting documentation for changes, including items such as engineering studies, validation protocols, technical reports, engineering drawings and SOP changes. Maintain Quality Management Systems for functional areas including Design Controls, Software, Development, Risk Management, Corrective and Preventative Action (CAPA) system and Nonconforming Material Reports. Support root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues. Be responsible for developing, measuring, and monitoring key performance indicators. Present metrics to senior management and colleagues on a quarterly basis Led the stability program transition from third party laboratory. Implemented the environmental monitoring program for weekly and monthly samplings in dry and wet side manufacturing process. Led the transition and implementation from Empower 2 to Empower 3 and HPLC’s qualifications. Oversight of the supplier’s qualification program. Coordinated validation activities with suppliers and validation department on various manufacturing and testing equipment. Developed and executed IQ, OQ and PQ qualifications for two Darwin Stability Chambers. Generated the capital appropriation request for the acquisition of Agilent GC and headspace supported by return of investment and cycle testing benefits.



Validation & Engineering Group, Inc.

• Puerto Rico
• Engineering Services
• 1 - 100 Employee

• Validation Consultant

  • 2017 - 2019

  Completed the cleaning validations of the wet and dry sides for American Labs. in Omaha, NE. Reduced the backlog from 2018 laboratory investigations to 0. In charge of all qualifications for new laboratory equipment. Laboratory start up for Kimberly Clark at Little Rock, AR Completed the cleaning validations of the wet and dry sides for American Labs. in Omaha, NE. Reduced the backlog from 2018 laboratory investigations to 0. In charge of all qualifications for new laboratory equipment. Laboratory start up for Kimberly Clark at Little Rock, AR



Patheon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Instrument Supervisor

  • 2014 - 2017

  Supervise and administration of all QC instrumentation services including preventive maintenance and calibrations. Managed projects for the acquisition and qualification of new equipment Responsible for the administration of all QC software applications. Generated procedure steps for the standardization of equipment identification using a nomenclature-based system. Established a system for distribution of calibrations within the month allowing to run a smooth schedule and minimizing unexpected situations for monthly closings Implementation of performance metrics for onsite resident contractors. Prepared presentation to request the acquisition of Empower 3 platform for Puerto Rico supported by assessment on top offender equipment issues, not supported hardware and risks, Right the First-Time, On Time Delivery metrics and Pros vs Cons Generated the Capital Appropriation Request for the transition project from Empower1 to Empower3. Proposal approved. Initial configuration of HPLC’s (48) and GC’s (2) into Empower3 platform and configured users accounts (65+), projects, user groups, users and applicable level of privileges. Validation of the Empower 3 software.



St. Jude Medical

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Technical Support

  • 2011 - 2013

  Evaluation and disposition of product. Implementation of quality standards to reduce product rejects in the manufacturing area (clean room environment). Generation of Yield Metrics, Pareto Charts, P-Charts and statistical reports for process monitoring. Performed execution vs procedure audits, work on investigations and assist to CAPA forum meetings. Evaluation and disposition of product. Implementation of quality standards to reduce product rejects in the manufacturing area (clean room environment). Generation of Yield Metrics, Pareto Charts, P-Charts and statistical reports for process monitoring. Performed execution vs procedure audits, work on investigations and assist to CAPA forum meetings.