Luis Rivera Email & Phone Number

Gurabo, Puerto Rico

Juncos, Pr, Puerto Rico

• Responsible to perform E-beam validation to new product following ISO standard• Perform Sterilization/microbiology assessment for any change in the product, product package configuration, or other changes to determine the impact on the sterilization or microbiology perspective.• Generates sterilization (radiation and steam sterilization) protocol and reports• Generate microbiology test method qualification for Bioburden and Endotoxin Testing.• Participate as part of the multifunctional team for changes related to the environmental control for the clean room following the ISO standard 14644-1 • Generate and up-date documents procedures using Agile System. • In charge to maintain the Quarterly Dose Audit program for E-beam and Gamma sterilization• Perform nonconformance investigations using Track Wise System related to Microbiology matter: Bioburden Failure, Environmental Failure, Endotoxin Test failure, Sterility Test failure and Quarterly Dose Audit failures.• Responsible to perform the annual requalification for Steam Sterilizers located in production area and Microbiology Laboratory.• Trained new Microbiology personnel • Evaluate product disposition related to microbiology issue.• Responsible to provide the Basic Training of Aseptic Technique concepts to new employee entering in the Clean Room Areas.• Assist as Reviewer for EtO annual requalification protocols and reports.• Serve as a mentor to the Associate Microbiologist and provide the training as required.• Coordinate activities and work with other functions to achieved assignments and tasks.• Actively participate in TUV audit, internal/corporate audit process for the Sterilization and Microbiology area.• Participate in the Supplier Audit Team for Sterilization and Microbiology services

Perform microbiology Testing that include product Bioburden test, Endotoxin test by Gel clot and automated system (turbidimetric and chromogenic method), Environmental Test, Microbial identification, media and solution preparation, growth promotion test, total count by membrane filtration for DI water System, generate Bioburden and LAL test method validation, ceate and update SOP, perform purchase requisition for laboratory supplies, training of new hire employees. EtO parameters verification and product release. Mantain trends of Microbial Data. Support to Sterilization validations for Steam and EtO Sterilization to Microbiologist/Sterilization Specialist. Perform investigation (CAPA) using TrackWise System.

Humacao, Puerto Rico

•Responsible for performing analysis of microbial limits for finished products and raw materials •Bioburden Analysis for Bulk products or products in process, media and packaging component•Analysis of Bacterial Endotoxin Test for Water For Injection and Clean Steam by Gel-Clot Method and KineticTurbidimetric Endosafe and for Product.•Perform Spray Pattern and Priming Test •Microorganism Identifications using Vitek system•Qualified in Media Simulation Studies•Sterility Test for Biological Indicators (BI’s)•Verification of Biological Indicator Population.•Performs and executes Protocols Validations for Microbial Limit Test of a new product according to USP, EP and JP• Performs and executes Protocol Validation for Sterility Test of a new product according to USP and JP•Growth Promotion Test and serials dilutions•Culture Media and Equipment Preparation•Perform Laboratory Investigations or process deviations when discrepancies are found•Generate and Review Standard Operating Procedures•In charge of new laboratory personnel training. Supervisoring responsabilities for the Environmental Process Inspector and Utility Process Inspector.oCoordinates the activities related to environmental sampling and/or utility sampling for validations process as well as special study and start-up of manufacturing area. oVerifies the documentation generated and related to this area. oPrepares weekly reports to the Microbiology Laboratory Manager.Environmental Process Inspector•Responsible for the Microbial Environmental Monitoring in the aseptic area according to the Manufacturing Environmental Program. •Generate Environmental Reports and related documents when discrepancies were obtained.

Gurabo, Puerto Rico

•Performed microbial environmental monitoring and analysis, compress air monitoring and testing in production area. Generated testing reports.•Conducted sampling and analysis of USP and Potable Water System.•Responsible for Equipment Cleaning Validation Testing and related reports.•In charge of Finish Products, Raw Materials and Drug substance analysis according to USP and European Pharmacopoeia.•Maintenance and qualification of microbiology test supplies, media, reagents and materials and stock culture preparation.•Prepared Microorganism’s Identifications using gram stain, API 20 NE System and Vitek automated speciation unit.•Performed Environmental Trend Analysis. •Conducted investigation reports associated with discrepancy or atypical results.•Handled the maintenance and calibration of Microbiology instrumentation, and related documentation.

Bachelor Of Science (B.S.), Microbiology, General

Bachelor Of Science (B.S.), Microbiology, General