Javier Rivera Email & Phone Number

Manatí, Puerto Rico

Añasco, Pr

Data Integrity Project

Guayama, Pr, Puerto Rico

Data Integrity Project

Puerto Rico

Humacao, Pr

Carolina, Puerto Rico

Las Piedras

Deliver 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.

(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.

Responsible 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.

Responsible 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.

Collection 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.

Responsible 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.

Develop Standard Operational Procedures (SOPs) for ERP SAP Project. Audit SOPs of different areas of the ERP SAP Project.

Worked 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 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.

Responsible 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.

Worked 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.