Reinaldo Colon Email & Phone Number

United States

Support the SmartVision project.

Juncos, Puerto Rico

• Develop and implement minor changes to improves the line operations. • Automation support to the inspection and packaging lines operations. • Automation support to implement a new labeler machine. • Automation support to implement a new compact packaging line.• Support the PQ and start up of a new packaging line. • Support process improvements activities related to CAPA, and line productivity. • Support on the development, characterization, recipe development, and implementation of new machines (with connection to a MES system).• Implement Raman analysis for product identity analysis.• Connect equipment/system to a manufacturing network.• Support activities to promote smooth starts up of lines after projects implementation by proactively integrating system optimization and system learning curve in the implementation process. • Support the serialization implementation at different packaging lines including requirement development, design evaluation, technical support, maintenance planning, and commissioning supports. • Support serialization software upgrade activities.• Support new project evaluation including projects scope definitions, project impacts, validation impacts, technical impacts, and vendor proposal evaluations.• Support new products introduction.• Technical support of serialization activities including characterization, commissioning, line set up, configuration, design, spare part evaluation, and system readiness preparation.• Develops and executes commissioning activities; and develops SOP for a packaging line modification to allow the transfer of a new product.• Develops new products and packaging systems characterization protocols.• Support the acquisition and implementation of new packaging line equipments. Developed requirements, design documents, characterization documents, commissioning documents, validation documents, and reports.

Humacao

1-Support and execute start up, validation, and SOP development for a Checkweigher machine.

Villalba

1- Supported twelve (12) packaging lines and seventeen (17) sterilization equipments with their respective information systems. 2- Transferred products and implemented new products.3- Developed, implemented, validated, or participated during the implementation of multiples software solutions to increase area productivity.4- Implemented multiples system (packaging equipment and process) improvements that reduce cost, and downtime; and increase system reliability and efficiency. 5- Supported none conformance investigations and implemented rework procedures. 6- Improved system maintenances procedures.7- Participated during the requirement development, specifications development, system design, and equipment proposal studies of new equipments and systems.

Las Piedras, Juncos

• Performed validation of HVAC room segregations project that includes updates of user requirement, system design, validation plan, SOP evaluation, and IOQ.• Performed software license audit for a waste management corporation.• Set up computers configurations.

Amgen, Janssen, Gsk, Lilly, Pfizer, Schering

Consultant in areas relates to validation, engineering commissioning, CAPA and none conformance; and technical services.• Performed Commissioning Qualification of a process management LAN for a manufacturing facility (Aspen IP.21). • Developed operational, disaster recovery, administrative and maintenance SOP for a process information management LAN. Developed and executed a license management plan.• Performed dry run, protocol corrections, validation documents execution and design modifications of a process utility control system that includes: Clean Steam, RO water, Water for Injection, process air, nitrogen, CIP/SIP (generation and distribution of process utilities).• Investigated instrument/ process tolerance ranges for equipment in the utility, packaging and process areas (Recollect process parameters).• Participated in client/ product complaints investigation.• Executed operational test for Delta V interfaces (sequences of operation) using Mimic simulator. • Developed validation plans for autoclaves and washers machines. • Developed and/or updated (including execution) of commissioning, IQ/OQ, user requirement, source code review, system design, and final reports documents for Washers systems.• Participated in the commissioning and IQ/OQ for a Roller Compactor machine.

Pfizer, Ivax, Bms

Consultant in areas relates to validation, engineering commissioning, CAPA and none conformance; and technical services.• Prepared part 11 assessment templates.• Developed and executed an IQ/OQ documents for two Chilled water pumps.• Developed IQ/OQ protocols for a Process Control System (PCS), an USP water system and a HVAC system. The Process Control System (PCS) includes 4 reactors, two vacuum systems, temperature and pressure control systems, dryer, day tanks, metering stations, vent system, and associated equipments. • Developed security and operational SOP for a HVAC and a PCS system. • Participated in the Validation of a capsule filler machine and check weight machine. The work includes validation plan, system specifications, system design, IQ, OQ, PQ development, and protocol execution. • Participated in the IQ/OQ development, protocol execution and final report generation of a packaging line that was used to manufacture a new product for stability and clinical studies. • Developed two operational and cleaning SOP for a labeler and a carton machine. • Executed an IQ/OQ protocol of a Network Control Module, and a vision system.• Participated in the development of Business Continuity Plan SOP and Access Control; and Security SOP. • Participated in the validation of a tablets packaging line. The process include 11 packaging equipments, 7 Allen Bradley PLC and 1 vision system. The project includes IQ/OQ development and Final Report generation.

Master Of Science (M.S.), Chemical Engineering, 4.0

Bachelor'S Degree, Chemical Engineering, 3.67

Activities and Societies: Tau Beta Pi