Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Luis Soto

Goldsboro,NC

Summary

An experienced, ambitious, and results-oriented manufacturing specialist with expertise in knowledge using Bio-pharmaceutical instruments, proficient in aseptic techniques and sampling. Also proficient in single use and bulk filling operations. Highly driven and hardworking professional who gets the job done right. I proudly served as a US Army Soldier with multiple deployments from 1995 to 2005. I work safely with great pride and discipline.

Overview

20
20
years of professional experience
1
1
Certification

Work History

Formulation Group Leader

Fresenius Kabi
01.2023 - Current
  • Monitored group performance on a regular basis, analyzing data and trends to identify areas for improvement.
  • Utilizes equipment for product formulation with the use of the distributed PCS7 control system for recipe and batch record executions.
  • Weighs outs and mixes precise amounts of chemicals according to specific formulas and monitors product output for mixing operations.
  • Responsible for the correct storage of raw materials.
  • Delegate tasks strategically and monitored progress for timely completion.
  • Attend staff meetings in the absence of supervisor and applied information from those events into daily activities.

Manufacturing Specialist III- Purification

Medicago USA
03.2022 - 04.2023


  • Carried out procedures for purification on TFF systems and Chromatography following SOP's and batch records.
  • Performed bulk processing and filtration involving processing parameters.
  • Prepared buffer solutions while performing CIP's and testing results using ph/conductivity using Thermo Fisher Orion Bench Top Meters.
  • Performs as the Downstream Team Log Book Coordinator and helped set up the team's tracking system during shut down operations.
  • Executed weight out and sampling under Vertical Laminar Air Flow Hoods and Bio-safety Cabinets.
  • Maintained a safe, clean and orderly work environment through effective housekeeping, 5S practices.
  • Accurately recorded activities and data on the Team Shift Notes.
  • Trained new employees on manufacturing processes, equipment operation, and company policies, fostering a skilled workforce.

Filling Operator III/ Compounder

Fresenius Kabi
10.2018 - 03.2022
  • Operated Compounding, filling, and autoclave equipment.
  • Used HMI's to execute specific product codes during Filling and Sterilization Cycles while also ensuring Batch Record documentation was accurate and complete.
  • Knowledge of CIP, SIP and VHP cycles on Groninger Filling, Isolator and E-beam (Gamma Radiation) equipment.
  • Performed necessary machine set-up, operation, changeover, adjustment, diagnosis, repair, and preventative maintenance on production equipment.
  • Operated in different grade environments and conducted routine aseptic interventions in a conventional Aseptic Isolator.
  • Performed Weigh-Outs and mixed precise amounts of chemicals according to specific formulas.
  • Operated formulation equipment: scale, and ph meters.
  • Assist Lab with collection of plate samples for Viable and Micro testing during filling.
  • Performed preventative maintenance tasks on isolators and autoclave equipment.
  • Performed cycle reviews, troubleshooting equipment, and recording them into logbooks.
  • Operated fully automated FANUC Robots and Overhead Gantry for loading and removal of Autoclaved products that are in the Sterilization Room.
  • Assisted as necessary during calibrations, PM's inspections and new product protocols.
  • Followed strict instructions on daily sanitation and mixture of chemicals.
  • Maintained yearly Aseptic Gowning certification.

Filling Operator

Anheuser-Busch Budweiser Plant
01.2005 - 06.2018
  • Operator/ Trainer on a high-speed packaging production line which included State of the Art equipment such as Fillers, Labelers and Packers in an FDA regulated industry
  • Performed product changeovers and conversions in accordance with company Standard Operating Procedures
  • Operated industrial equipment such as forklifts, in order to unload, load and transport packaging materials, raw materials, and finished products to appropriate departments for shipping
  • Operated process control equipment and handled manual activities required to monitor and control the movement of our products
  • Conducted process quality control checks and identified equipment malfunctions reported issues to appropriate craft shops.

Education

Associate of Applied Science - Business Administration

Berkeley College
New York, NY
03.1995

Skills

  • Leadership Knowledge using the following instruments; Digital ph and conductivity meters, and scales Skilled in Single use and Bulk Filling Operations Knowledge of HMI, LIMS applications and trained on PCS7 and SAP systems Qualified Trainer, Proficient in Automated Formulation, Aseptic filling Techniques, sampling and interventions SOP documentation and revisions Calibration, Scales

Certification

  • United States ARMY Primary Leadership Course, 09/2001
  • Biotechnology Certification, 2022
  • Yellow Belt Certification, 2023

Languages

English
Native or Bilingual
Spanish
Native or Bilingual

Timeline

Formulation Group Leader

Fresenius Kabi
01.2023 - Current

Manufacturing Specialist III- Purification

Medicago USA
03.2022 - 04.2023

Filling Operator III/ Compounder

Fresenius Kabi
10.2018 - 03.2022

Filling Operator

Anheuser-Busch Budweiser Plant
01.2005 - 06.2018

Associate of Applied Science - Business Administration

Berkeley College

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