ALBERT NEGRON
Hatillo
Summary
Experience professional As a Subject Matter Expert (SME), a Computer System Validation Engineer/Specialist should be a site computer system administrator for equipment and instrument computer systems and C&Q. Risk Assessment and FMEA/ Change Control and CAPA. Write precise as well as thorough Validation document lists and Quality to Validation reports, validation plans, and Master Documents proactive IT Web and Development Applications. Experience in back-end programming, relational databases, and the development and maintenance of complex and critical systems. Adept at testing, including performance, functional, regression, designing, implementing.
Overview
9
9
years of professional experience
Work History
C&Q Consultant
BRISTOL MYERS SQUIB
10.2023 - Current
- Responsible to create all documentation software validation IQ, OQ and PQ
- Ensure the correct operation of the processes and systems involved through the GAMP methodology to achieve automation processes
- Ability to independently assess and monitor the project validation deliverables compliant to company procedures like mapping business requirements to test plan, etc
- Review validation documentation for adherence to computer systems validation (CSV) protocols, and applicable industry accepted standards
- Review and create computer systems validation (CSV) protocols, and applicable industry accepted standards
- Verifies entered data by reviewing, correcting, deleting, or reentering data in Maximo platform
- Data entry in ALM application
- Equipment qualification: Autoclaves, Isolators, Density Meter, Steam Clean, CSV LabX
- Carry out all aspects of a validation project, including Validation Plan (VP) User Requirements Specification (URS)
- Design and executed comprehensive test plan to validate hardware functionality ensuring adherence to industry standards
- Support validation team responses for audit findings as well as corrective actions
- Analyzes test results and generated comprehensive reports providing valuable insight and recommendations for hardware design
- Liaised with customers, management, and sales team to better understand customer needs and recommend appropriate solutions.
- Evaluated client needs and expectations, establishing clear goals for each consulting engagement.
Validation Engineer
BAXTER
01.2022 - 07.2023
- Responsible to create all documentation software validation IQ, OQ and PQ
- Ability to independently assess and monitor the project validation deliverables
- Collaborate with Business SMEs, IT and vendor partners to ensure alignment of business requirements and functional designs
- Qualification equipment: HVAC system (Touch Point, Traffic Flow), Destille Water (HMI).
- Review validation documentation for adherence to computer systems validation (CSV) protocols, and applicable industry accepted standards
- Ensure to process Client System subsequent development in real time as delivered for validation
- Mentored junior engineers in best practices for validation engineering methodologies improving team skillsets.
- Established strong working relationships with vendors ensuring smooth communication during project deployment.
- Conducted root cause analysis on deviations during validation activities, enabling timely resolution of technical issues.
- Reduced operational risks associated with validated systems through periodic review assessments and targeted revalidations when necessary.
Validation Testing & Analyst II
ABBVIE PHARMACEUTICALS
10.2019 - 01.2022
- Investigate, analyze, design, develop, install, evaluate and maintain bio-pharmacy plants manufacturing information systems
- Follow appropriate corporate policies, industry standards, government regulations, plant and departamental procedures
- Functional knowledge around POMS systems and able to support validation implementation
- Creation flowcharts recipe and contribute to development Recipe on POMSnet
- Write precise as well thorough Validation document list and Quality to Validation reports, Validation Plans
- As a Subject Matter Expert (SME), Computer System Validation Engineer/Specialist system
- Computer system administrator for equipment and instrument computer systems
- Collaborated with cross-functional teams to identify opportunities for process improvement and increased efficiency.
- Improved internal knowledge sharing by developing comprehensive documentation outlining standard operating procedures for various tasks.
IT Analyst Specialist
SNC Technical Services
03.2016 - 09.2019
- Install and configure appropriate software and functions according to specifications
- Troubleshot critical incidents involving network outages or security breaches, swiftly implementing remediation plans to minimize impact on operations.
- Optimized system performance by conducting regular audits and resolving identified issues.
- Provided expert support, troubleshooting complex technical problems for end-users in a timely manner.
- Improved user experience, monitoring feedback and making necessary adjustments to software applications.
- Work with Projects Managers, to report analyzed data and communicate results, keeping IT activities
- Install and configure hardware and software components
- Data protection and recovery
- Analyze IT requirements and provide objectives advice on the use of IT
Education
Master of Science - Software Engineering
COLORADO TECHNICAL UNIVERSITY-ONLINE DIVISION
Colorado Springs, CO09.2018
Bachelor of Science - Web Technology and Development Applications
NATIONAL UNIVERSITY COLLEGE
San Juan, Puerto Rico12.2016
Skills
- Agile methodology
- C
- C#
- Oracle
- MySQL
- Visual Studios
- Performance and optimization
- SQL Server
- ASPNet
- PHP
- Microsoft Access
- Strong decision maker
- TCP/IP Protocols
- JavaScript
- Accounting system and software
- SAP
- POMSnet
- LIMS
- Problem-Solving
- Attention to Detail
- Team Leadership & Development
- Client Relationships
- ALM
- DCA
- Financial analysis
- Excel
- Word
- Visio
- Maximo
- Bilingual in Spanish/ English
- Efficient Database and Networking
- Willing Relocated
Timeline
C&Q Consultant
BRISTOL MYERS SQUIB
10.2023 - Current
Validation Engineer
BAXTER
01.2022 - 07.2023
Validation Testing & Analyst II
ABBVIE PHARMACEUTICALS
10.2019 - 01.2022
IT Analyst Specialist
SNC Technical Services
03.2016 - 09.2019
Master of Science - Software Engineering
COLORADO TECHNICAL UNIVERSITY-ONLINE DIVISION
Bachelor of Science - Web Technology and Development Applications
NATIONAL UNIVERSITY COLLEGE
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