Summary
Overview
Work History
Education
Skills
Timeline
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Hermarie Romero

Garner,NC

Summary

Skilled Bioprocess Technician with hands-on experience in cell culture, proficient in adhering to Standard Operating Procedures (SOP), batch records, and job aids. Demonstrates strong adherence to Current Good Manufacturing Practices (cGMP) and aseptic techniques. Self-motivated and observant, with excellent critical thinking skills, providing detailed information during troubleshooting to ensure quality products. Expertise in single-use upstream cell expansion, transfection of embryonic suspension cells, and supporting start-up activities for gene therapy. Fluent in Spanish.

Overview

14
14
years of professional experience

Work History

Bioprocess Technician

Pfizer Pharmaceutical Company
10.2022 - Current

  • Perform upstream operations from vial thaw through perfusion, transfection, and harvest filtration.
  • Set up of 200L and 2000L bioreactors using single-use pre-sterilized customized bags.
  • Performed a variety of in-process testing using analytical microbiological methods and instruments.
  • Maintained information in manufacturing support systems used for gap assessments, variance tracking, and deviations.
  • Utilized enterprise systems to support manufacturing operations including, but not limited to, SAP, LIMS, PDOCs, Delta V, etc.
  • Supported investigations to determine root cause and implement CAPAs.
  • Review manufacturing documents and records.
  • Remain consistently compliant with cGMP and 5S standards.
  • Proficient in following SOPs and MBRs to ensure the safety of the product to reduce the risk of quality errors and contamination.
  • Conduct analytical activities such as sample dilutions, pH, and conductivity readings.
  • Assisted with the red lining of new MBRs, SOPs and Job aids during water runs.
  • Monitored and supported the Safety Committee Lead with various activities, ensuring the completion of current ladder inspections.
  • Ensured a safe work environment by diligently following established safety protocols and guidelines throughout all processes.
  • Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.



Manager/Insurance Agent

Raleigh Durham Check Cashers Inc.
08.2010 - 03.2023
  • Maintained transaction records to ensure accuracy of all relevant information was captured following regulations and procedures.
  • Accomplished multiple tasks within established timeframes.
  • Managed and motivated employees to be productive and engaged in work.
  • Maximized performance by monitoring daily activities and mentoring team members.
  • Cross-trained existing employees to maximize team agility and performance.




Manufacturing Associate (Contractor)

CSL Seqirus
05.2022 - 10.2022
  • Hands-on resource in the production of the Flu Vaccine.
  • Determined and corrected minor machine malfunctions.
  • Completed process steps according to SOPs and MBRs.
  • Prepared production equipment, like vials, to get filled within an isolator.
  • Work within a teamwork environment following cGMP.

Education

Associate of Applied Science - Biopharmaceutical Technology

Wake Technical Community College
Raleigh, NC

Certificate - BioWork Process Technician

Wake Technical Community College
Raleigh, NC
12.2021

Skills

  • cGMP Compliance
  • LIMS
  • SAP
  • Delta V
  • PDOCs
  • Process development
  • Aseptic techniques
  • Upstream Processing
  • Manufacturing Operations
  • Problem Solving
  • Teamwork
  • Communication



Timeline

Bioprocess Technician

Pfizer Pharmaceutical Company
10.2022 - Current

Manufacturing Associate (Contractor)

CSL Seqirus
05.2022 - 10.2022

Manager/Insurance Agent

Raleigh Durham Check Cashers Inc.
08.2010 - 03.2023

Associate of Applied Science - Biopharmaceutical Technology

Wake Technical Community College

Certificate - BioWork Process Technician

Wake Technical Community College

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Hermarie Romero