Experience

Emergent BioSolutions

• United States
• Biotechnology Research
• 700 & Above Employee

• Advisor, Validation

  • Apr 2022 - Present



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager, IT Compliance

  • Feb 2020 - Apr 2022

  Accountable for the strategies executions for IT Computerized Systems, Computer System Validation and Data Integrity Compliance for Computerized Systems, to assure site adherence to regulatory requirements, BMS Corporate CSV and Data Integrity Directives, and site procedures and methodologies. Perform computerized systems validation for the site systems at the Sterile, NonSterile, Utilities, Facilities and QC/QA functional areas at Bristol-Myers Squibb Manati manufacturing facility according to all Federal, International, State and Corporate Regulations. Responsible for the design, development and execution of software & computer validation protocols and computer validation plans for computerized systems supporting the site areas. Assure the systems are compliant with all CSV and data integrity requirements for computerized systems before releasing the system for its intended use. Show less



Weil Group, Inc.

• Outsourcing/Offshoring
• 1 - 100 Employee

• Manufacturing Automation Engineer

  • Jun 2018 - Feb 2020

  Working as a Data Integrity SME at Bristol Myers Squibb, Manatí site. Responsible of performing DI Assessment to Laboratory, Manufacturing, Inspection & Packaging Equipments. Performed Data Integrity remediation projects for manufacturing areas. Revalidation on Computerized System to align with data integrity requirements and URS, TM, and IOQ gaps. Remidiation projects for the new Parental Vial Area Optima Isolator. Working as a Data Integrity SME at Bristol Myers Squibb, Manatí site. Responsible of performing DI Assessment to Laboratory, Manufacturing, Inspection & Packaging Equipments. Performed Data Integrity remediation projects for manufacturing areas. Revalidation on Computerized System to align with data integrity requirements and URS, TM, and IOQ gaps. Remidiation projects for the new Parental Vial Area Optima Isolator.



PACIV

• United States
• Industrial Automation
• 1 - 100 Employee

• Automation/Validation Engineer

  • Jun 2017 - Jun 2018

  Performed Data Integrity Assessment including Data Mapping for CSV at Amgen, Juncos site. Worked as Project Manager/ Facilities Engineer at Plaza Food Systems Warehouse in Caguas. Performed Data Integrity Assessment including Data Mapping for CSV at Amgen, Juncos site. Worked as Project Manager/ Facilities Engineer at Plaza Food Systems Warehouse in Caguas.



ACS Control Services, Inc

• Dorado, Puerto Rico

• Validation Specialist

  • Jan 2015 - Jun 2017

  Manage Change Request Write qualification documents to support commissioning, IOQ, AIQ, OQ, and activities for controlled temperature environments comprising check for compliance with corporate standards, regulatory requirements and technical expertise. Actively participate during all phases of qualification: evaluate projects, provide guidance and technical information to others, generate protocols, execute qualification activities, analyze resulting data and prepare reports. Lead all assigned qualification activities Determine and establish requirements for qualification activities IT Support Show less