Manufacturing Information Technology

Luis Cosme

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Summary of Qualifications

Information Technology System Administration professional with experience in analog/digital circuitry, networking fundamentals and PC/Mobile technologies looking to gain experience with new IT skills at an upstanding company.

Education

My Computer Career, Raleigh, NC Graduate April 2018

Information Technology System Administration

Current certifications: CompTIA Mobility+, Server +, MTA Mobility and Device Fundamentals, MTA Security Fundamentals

ECPI University, Greensboro, NC Graduate January 2015

Electronics Engineering

Associate of Science in Electronics Engineering Technology

Electronics Technician Association Certified Fiber Optics Installer

Soldering Certified

Professional Skills and Qualifications

Installing and troubleshooting PC hardware, mobile devices

Installing Windows 7, Windows 8/ 8.1, Windows 10, Ubuntu and OSX

Maintaining and troubleshooting Windows, Linux and OSX Operating Systems

Installing and maintaining Microsoft Azure AD

Installing, maintaining troubleshooting, and uninstalling software, as well as peripherals

Basic working knowledge of Linux commands

Setting up Windows firewall and other third-party firewall software

Installing operating system service packs, updates, and other security patches

Setting up and maintaining anti-virus software

Implementing router and switch security techniques

Installing, maintaining, and troubleshooting LAN networks

Data recovery and data communications

Troubleshooting network connectivity issues

Information system fundamentals

Assisted in startup projects with communicating effectively with management and vendors.

Investigated equipment issues quickly so a solution could be found before it was escalated to a higher level

Provided training to new employees on equipment, processes, procedures and software programs

Participated in troubleshooting processes and equipment problems.

Created and revise batch records, SOP’s (Standard Operating Procedures), and other GMP (Good Manufacturing Practices) documents

Professional Experience

Manufacturing Associate III, Biogen May 2014 to Present

• Responsible for manufacturing of clinical or commercial products in a GMP manufacturing environments.

• Operate production equipment for oral solid dose process that may include dispensing, granulation,

compression, coating, printing and or encapsulation, process monitoring, sampling, transfer and analysis.

• Performed solution preparation operations.

• Maintained records and clean room environment to comply with regulatory requirements utilizing Good

Manufacturing Practices (GMP) and Standard Operating Procedures (SOP).

Production Technician, ConvaTec January 2014 to April 2014

• Performed a wide variety of production tasks

• Improved and optimize production operations

• Ensured consistent high quality and productive operations

Associate Technician, Merck September 2013 to December 2013

• Operated processing equipment in accordance with Standard Operating Procedures (SOP's), in all classified areas (Grade A/B/C/D).

• Used proper aseptic technique while performing tasks in Grade A/B areas.

• Participated in troubleshooting processes and equipment problems.

• Participated in the creation and revision of batch records, SOP's, protocols, and other GMP documents.

• Troubleshoot process equipment and interacted with maintenance personnel.

Plant Technician, Proctor and Gamble March 2013 to September 2013

Operated, maintained, and cleaned automated equipment

Operated essential material handling equipment at the site e.g., clamp truck, forklift, hand trucks, etc.

Maintained accurate records and data

Manufacturing Group Leader, Ranbaxy Pharmaceuticals May 2008 to February 2013

Performed optimization, process studies, characterization, and process validation as well as process troubleshooting, process optimizations and assisted in investigations.

Assisted production shifts to ensure smooth transfer of new products or process enhancements of existing products.

Performed manufacturing of process pre-validation and validation batches.

Performed manufacturing of exhibit test batches

Updated Master Batch Records and maintenance in current status.

Supported R&D in process development, process optimization, and filing of new ANDAs and NDAs.

Performed process evaluation using statistical tools and perform trend analysis.

Prepared SOPs related to Manufacturing Science & Technology Group (MSTG) and maintenance in current status.

Troubleshoot and prepared Corrective and Preventative Action Plans (CAPAs).

Supported compliance investigations, commitments (CAPA), and change controls.

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