Summary
Skills
Work History
Education
Languages
Key qualifications
Overview
Generic

Carlos Ortiz Arroyo

College Station,TX

Summary

Dynamic Manufacturing Supervisor with a proven track record at FUJIFILM Diosynth Biotech, excelling in team management and continuous improvement. Skilled in document management and performance evaluation, I foster collaboration and drive quality-driven results, enhancing training programs and operational efficiency. A self-driven leader committed to achieving excellence in manufacturing processes.

Skills

  • Organized
  • Fast learner
  • Self-driven
  • Competitive
  • Team player
  • Quality-driven
  • Team management
  • Communication skills
  • Task prioritization
  • Work area inspection
  • Document management
  • Manufacturing processes
  • Performance evaluation
  • Continuous improvement

Work History

Manufacturing Supervisor

FUJIFILM Diosynth Biotech
College Station, TX
07.2024 - Current
  • Led the team to complete daily activities, adhering to the schedule, and improving the training curriculum.
  • Train new hire personnel, and schedule training.
  • Deviation, CAPA, and Change Control generation and closing.
  • Coordinated equipment maintenance with other departments.
  • Troubleshooting and decision-making.
  • Coordinate materials, chain of custodies, and batch records to avoid delays in manufacturing.
  • Manufacturing review of batch records and logbooks.
  • Brought forward document improvements, Batch Records, SOP, and Work Instructions.
  • Implemented a new system for shift handovers and training, fostering a culture of continuous improvement.
  • Scheduled a 1-on-1 with the team to set goals and address any concerns.
  • The supervisor role has been extended to include solution preparation and downstream.
  • Update documents using Veeva (logbooks, batch records, SOPs).
  • Conducted regular meetings with staff to discuss performance issues, develop improvement plans, and ensure compliance with regulations.
  • Evaluated employee performance regularly to provide feedback on progress toward goals.
  • Resolved conflicts between departments or personnel promptly, while maintaining positive working relationships.
  • Inspected completed work to verify conformance with quality standards.
  • Enforced a preventive maintenance schedule for department equipment.

Manufacturing Technician IV

FUJIFILM Diosynth Biotech
College Station, TX
10.2022 - 07.2024
  • Managed the team to achieve goals, supported the manufacturing area, and collaborated with downstream, solution prep, automation, and maintenance teams.
  • Support the team in the manufacturing area by getting the detailed information they need or imparting knowledge.
  • As the lead, look for areas of opportunity, and create a plan to solve it.
  • Maintain the area in working condition for the next shift, and organize.
  • Proficient in SAP HANA, Delta V, and Blue Mountain, TrackWise.
  • Prepared the area and documents for the audit, and led team decisions to achieve schedule adherence.
  • Daily MFG review of batch records.
  • Access for Master Control to improve documents (SOP/WI).
  • Train new hire personnel in the area.
  • Deviation and CAPA generation.
  • Coordinate with other departments to schedule equipment maintenance, and support the activities.
  • Troubleshooting and decision-making during the shift.
  • Trained new employees on machine operation, safety procedures, and work instructions.
  • I informed the supervisor of situations detrimental to production, quality, or safety goals.
  • Worked using single-use systems and single-use mixers.
  • Adhered to all applicable regulations, policies, and procedures for health, safety, and environmental compliance.
  • Oversaw and inspected production processes.

SR Manufacturing Associate

Amgen AML
Juncos, PR
08.2020 - 10.2022
  • Managed daily activities of team, achieving key objectives in Cell Culture and serving as Subject Matter Expert and Safety Champion.
  • Monitored critical processes using SIMCA, PI Process Book, PI Batch, and CDOCs.
  • Utilized LIMS, Maximo, and PasX to enhance operational efficiency.
  • Prepared and led WCT (Tier 2 or 3) meetings to drive project alignment.
  • Supported Engineering, Maintenance, Quality, and Process Development teams for seamless operations.
  • Reviewed documentation and implemented SOPs within the documentation team.
  • Trained colleagues while ensuring training materials remained current.
  • Ensured schedule adherence and effective team management.

Manufacturing Associate

Amgen AML
Juncos, PR
08.2016 - 07.2020
  • Manufacturing Associate of the Media Preparation for Cell Culture.
  • Support the Cell Culture area by manufacturing or preparing all the media or buffers required on a daily basis.
  • Maintain schedule adherence to support run rate increase for new product introduction.
  • Filter integrity testing of single and multiple filter element housings.
  • Completed training on the use of PasX electronic batch records.
  • Review the documentation of electronic batch records.
  • Learned to use pressurize, steam, and CIP systems to prepare the tanks.
  • Replenish the Kanban for all materials required during the shifts.
  • Troubleshooting of transfer panels, jumper connections, and bioreactors.
  • Organized work area for maximum efficiency, and maintained cleanliness at all times.
  • Monitored process operations to comply with specifications.
  • Maintained safe and efficient operations in a fast-paced environment.
  • Assisted in troubleshooting technical issues with machines or processes.
  • Maintained accurate documents, records, and logbooks to track production.

Temporary Manufacturing Associate

Spectra Force (for Amgen)
Juncos, PR
11.2014 - 05.2016
  • Manufacturing Associate of the Media Preparation for Cell Culture.
  • Support the Cell Culture area by manufacturing or preparing all the media or buffers required on a daily basis.
  • Maintain schedule adherence to support run rate increase for new product introduction.
  • Filter integrity testing of single and multiple filter element housings.
  • Completed training on the use of PasX electronic batch records.
  • Review the documentation of electronic batch records.
  • Learned to use pressurize, steam, and CIP systems to prepare the tanks.
  • Replenish the Kanban for all materials required during the shifts.
  • Troubleshooting of transfer panels, jumper connections, and bioreactors.
  • Organized work area for maximum efficiency, and maintained cleanliness at all times.
  • Monitored process operations to comply with specifications.
  • Maintained safe and efficient operations in a fast-paced environment.
  • Assisted in troubleshooting technical issues with machines or processes.
  • Maintained accurate documents, records, and logbooks to track production.

Education

Bachelor's Degree - Cellular and Molecular Biology

University of Puerto Rico
Rio Piedras, San Juan
01.2014

Languages

English
Advanced (C1)
C1
Spanish
Proficient (C2)
C2

Key qualifications

  • Document Development: Developed and implemented SOPs for new equipment, ensuring seamless integration and operation.
  • Manufacturing Expertise: Trained staff across all functional areas, increasing run rates and ensuring successful production.
  • Fast Learner: Quickly adapted to new responsibilities and skills, consistently delivering high-quality results.
  • Organizational Skills: Highly organized and detail-oriented, with effective prioritization and multi-tasking abilities.
  • Interpersonal Skills: Excellent communication skills, able to influence and lead multi-disciplinary teams.

Overview

11
11
years of professional experience

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Carlos Ortiz Arroyo