Javier Rivera Email and Phone Number
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Javier Rivera is a Data Integrity Officer at Thermo Fisher Scientific at Thermo Fisher Scientific. He possess expertise in computer system validation, 21 cfr part 11, validation, project management, automation and 27 more skills.
Thermo Fisher Scientific
View- Website:
- thermofisher.com
- Employees:
- 53105
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Data Integrity Compliance OfficerThermo Fisher Scientific May 2020 - PresentManatí, Puerto Rico
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Csv ConsultantJohnson & Johnson Oct 2019 - Dec 2019Añasco, PrData Integrity Project -
Senior C&Q ConsultantBaxter International Inc. Jan 2018 - Mar 2019 -
Senior Quality ConsultantPfizer Apr 2017 - Dec 2018Guayama, Pr, Puerto RicoData Integrity Project -
Senior C&Q ConsultantBaxter International Inc. Jun 2016 - Apr 2017Puerto Rico
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Senior C&Q Lead ConsultantBristol-Myers Squibb Jun 2015 - May 2016Humacao, Pr -
C&Q Senior SpecialistEli Lilly And Company Apr 2014 - May 2015Carolina, Puerto Rico -
C&Q Senior SpecialistMerck Sep 2013 - Mar 2014Las Piedras -
Engineer Compliance SpecialistJohnson & Johnson Feb 2013 - Sep 2013Deliver aggressive plans to archive Consent Decree Work Plan goals remediation project.Ensure project goals and objectives are well understood by functional areas.Performed high level assessments of the validated state for the Packaging Lines, HVAC, Compression, and Printing equipment.Conduct FMEAs, identify Critical Process Parameters (CPP), Critical Quality Attributes (CQA), and review Qualification Documents for the Process Verification program – as part of the process validation lifecycle, to assess and remediate qualification gaps.
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Sr Project Management AssociatedAmgen Sep 2011 - Feb 2013(LRPM 2011 & 2012 Program)Manage the PCS project qualification documentation (schedule, trainings, meetings, workflows, evaluation of purchasing equipment). Develop, review, execute and reporting of equipment, automation and computer systems qualification (Commissioning and Validation Documents: VP, URS, DS, SAT, TM, IOQ, Report, and assessments). Develop and execute Commissioning Documents (Commissioning Plan, Commissioning Protocols, URS, Reports,) for the following plant utilities (VFDs, Cooling Tower and HVAC Pumps, AHUs, BMS, PLC, and Electrical equipment).Develop and provide training on new Standard Operating Procedures. -
Validation SpecialistCr Bard Aug 2011 - Oct 2011Responsible for the development of Validation Documents (Matrix, OQ Protocol, Computer System Validation assessment) for the Visual Inspection End of Line Packing area project.Standard Operating Procedures development and training. -
Validation SpecialistPfizer Jul 2011 - Sep 2011Responsible of develop Decommissioning Plans and System Retirement Implementation Protocols of manufacturing and packaging system. Captures information about a system and determines retention time according to company policies and legal requirements.
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Electronic Data AuditorMcs Oct 2009 - Jun 2011Collection of electronic data and audit for evaluation and verify consistency with standards, policies and procedures.Generated data matrixes and final report and provided training to employers in the configuration of the system database. -
Validation SpecialistEli Lilly And Company Jun 2008 - Feb 2009Responsible for the development of Validation Documents (Matrix, Linear Flow, CFR 21 Part 11 ‘Electronic Signature and Electronic Batch Records’ assessment) for the SmartLab project.SOP development and Methods for Smart Lab (PAT) data acquisition software applied to the laboratory processes.Provided training of software utilization to laboratory personnel.
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Validation SpecialistAmgen Sep 2007 - May 2008Develop Standard Operational Procedures (SOPs) for ERP SAP Project. Audit SOPs of different areas of the ERP SAP Project.
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Csv Validation SpecialistGlaxosmithkline Oct 2006 - Sep 2007Worked in a Consent Decree Environment. Developed and execute Commissioning, Validations, CSV, IQ, OQ Protocols, and decommissioning documents for laboratory equipment. Responsible for the development and execution of IQ, OQ, and CSV validations documents for manufacturing and packaging equipment. Responsible for the audit computerized systems validation documents of manufacturing, laboratory equipment and software (EMS). -
Project Leader / Validation SpecialistMayne Pharma Aug 2005 - Oct 2006Project Management of the Thermo Atlas system. Developed Computer Validations Documents (URS, FRS, IOQ, and SOPs) for the Thermo Atlas CDS version 8.1 and PLC controlled manufacturing equipment. -
Validation SpecialistBiovail May 2005 - Jun 2006Responsible for the development and execution of IQ, OQ, CSV & PQ validations documents for laboratory and biotech manufacturing equipment. Audit validation protocols of software, and laboratory equipment. -
Validation SpecialistSchering-Plough Apr 2003 - Apr 2005Worked in a Consent Decree Environment.Execution IQ and OQ Validation Documents of Water System for Process Area. Supported Quality Engineering Laboratory Instrumentation Department, developing and executing Decommissioning, Commissioning, and Installation and Operational Qualification of Laboratory instruments. Developed and executed Validations Protocols for Analytical Methods.
Javier Rivera Skills
Javier Rivera Education Details
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Interamerican UniversitySciences; Chemistry
Frequently Asked Questions about Javier Rivera
What company does Javier Rivera work for?
Javier Rivera works for Thermo Fisher Scientific
What is Javier Rivera's role at the current company?
Javier Rivera's current role is Data Integrity Officer at Thermo Fisher Scientific.
What is Javier Rivera's email address?
Javier Rivera's email address is ja****@****her.com
What is Javier Rivera's direct phone number?
Javier Rivera's direct phone number is +178720*****
What schools did Javier Rivera attend?
Javier Rivera attended Interamerican University.
What skills is Javier Rivera known for?
Javier Rivera has skills like Computer System Validation, 21 Cfr Part 11, Validation, Project Management, Automation, Sdlc, Csv, Gmp, Fda Gmp, Consent Decree, Commissioning, Process Improvement.
Who are Javier Rivera's colleagues?
Javier Rivera's colleagues are Prakash Gawde Gawde, Jorma Lampinen, Francisco Javier Bustos Caceres, Grant Fernstrum, Marvin Choo, Jen K., Hideyasu Hattori.
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