GUSTAVO VARGAS
Stroudsburg,PA
Summary
A team member who is able to guide/delegate task large and small groups in a manufacturing environment. In skilled manufacturing and production team member with technical skills and attention to detail. Understands safety and consistently exceeds performance requirements. Dedicated to quality processes and final product results.
Overview
15
15
years of professional experience
Work History
Manufacture Cell Culture Media Preparation Support
Bristol Myers Squibb
Summit, Nj
10.2023 - Current
- Follow manufacturing Standard Operating Procedures (SOPs) in a controlled, cleanroom environment
- Follow Aseptic gowning procedures entering the Biological Safety cabinet area
- Read, execute and document steps in according to GMP batch record
- Maintain up to date records for training on controlled, approved GMP procedures for Media preparation to support CAR T manufacturing
- Assist with Lab Support activities: Coordinate with Warehouse Operations to move materials into the process suites and serve as a runner when needed
- Participate in shift exchanges of information to ensure seamless operations
- Prep Batch Records
- Aseptically pre and post clean the BSC (Biological Safety Cabinet)
- Preform and Verify process
- Reviews of batch Records and logbooks
- Prep, Run and troubleshot machines
- Create EM (Electronic Monitoring) plan, perform testing of in-process.
- Trained new employees on proper use of machines, safety procedures, and job requirements.
- Coordinated activities between different departments involved in the production process.
- Ensured compliance with applicable regulations related to health, safety, or environmental standards.
- Set up and operated production machinery according to specific standards and protocols of company.
- Documented all changes made to existing manufacturing processes and communicated updates with relevant personnel.
- Monitored inventory levels of raw materials and ordered additional stock when needed.
- Trained new employees regarding equipment operation and product assembly.
- Calibrated machines to adhere to quality standards and maintain required productivity levels.
- Reduced health and safety risks with strict adherence to safety protocols and PPE requirements.
- Conducted daily safety inspections of workstations and reported any potential hazards to management.
- Measured and weighed items to meet quality standards and prevent waste.
- Assisted in troubleshooting issues that arose during the manufacturing process.
Production Technician/Room Lead
Sanofi Pasteur
Swiftwater, PA
07.2019 - 03.2022
- Before extracting eggs from the cold box make sure they meet the minimum and not over the maximum time/temperature ranges, then scan(SAP) and document in the BPR(Batch Production Records)
- Make sure eggs are are loaded candle and inspected into harvesters, then document the results to shift reports and BPR
- Troubleshoot machinery (Harvesters/Cart Washer/Tray Washer) manually or via HMI
- Create Work orders via SAP for equipment that need to be fix by Maintenance
- Review logbooks for proper documentation and cleaning of coldboxes/Machines/Carts and coldboxes temperatures
- Conformation of Phase are complete in SAP.
- Trained new personnel in operating procedures for various pieces of production equipment.
- Track coordinate breaks
- Delegate task to groups of 10-25
- Maintained a clean and safe work environment by adhering to all safety regulations.
- Recorded daily production data into an electronic database system for tracking purposes.
- Monitored production processes, identified problems, and took corrective action when necessary.
- Documented production logs by entering data into computer system.
- Maintained machines by performing inspections and troubleshooting problems with equipment.
- Trained new employees on company and safety standards, providing assistance and remediation with issues.
- Reported any nonconformities or discrepancies in product quality to supervisors.
Manufacturing Technician/Manpower Supervisor
Sanofi Pasteur
Swiftwater, PA
01.2010 - 08.2018
- Delegate tasks to groups of 10
- Review and approve time cards
- Play a role in loading, candling, filling and inspecting flu-inoculated eggs before fluids are transferred to Clarification
- Take part in the disassembly and cleaning of the North and South Harvest machines after completion of production
- Responsible for pre-inspecting the machines and assisting a Manager or Designee as they do the final inspection
- Supervise TPW’s (Temporary Production Workers), maintain attendance, coach them when an issue arises
- Document in results in Logbooks/BPRs/Shift Reports
- Stay in constant contact with Sanofi Pasteur Managers and Supervisors to ensure that TPW’s are contributing to production goals as required
- Take control of all HR related issues for the TPW’s and report them to Shift Managers
- Identify and address attendance issues and arrange replacements as required
- Identify and address performance issues as well as safety issues and make appropriate recommendations
- Communicate shift performance and incidents to Manpower site management
- Assist in training functions and ensure TPW’s remain above 95% in their trainings(IsoTrain)
- Report and aid in any workplace injury
- Assist B59 Harvest Training Coordinator in organizing training for new TPW’s as well as assign Qualified Trainers.
- Wrote thorough reports detailing production quality findings and proposed recommendations.
- Trained new employees on company and safety standards, providing assistance and remediation with issues.
- Kept production logs and maintained job material inventory.
Production Technician
Sanofi Pasteur
Swiftwater, PA
- Follow the proper channels of Aseptic gowning before entering the production floor document when I enter the floor and make it exist within 4 hours
- Receive the eggs from the truck check the Temp tails before transporting the eggs in a Aseptic area the eggs
- Prep Inoculation for operations, take the seed then mixed it with the buffer and set in bottles in the refrigerator till its ready to be processed, clean the incubators then candle the eggs then move them to the incubators
- Manually puncture/inoculate/seal in sets within 45 minutes .
Production Artist
Outsourcing USA
Dallas, PA
01.2013 - 12.2024
- Log production
- Follow written directions
- Create, edit and resize ads for different publications.
- Edit, create and add images
Education
Associate of Science Degree in Visual Communications -
Lehigh Valley College
08.2007
Skills
- Lean Six Sigma yellow belt
- HTML
- CSS
- Production Logging
- Computer-Aided Design
- Product Assembly
- Teamwork and Communication
- Strong Work Ethic
- Production Documentation
- Health and Safety Regulations
- Computer Skills
- Positive Attitude
- Machine Setup and Shutdown
- Production Operations
- Warehouse Operations
- Preventive Maintenance
- Materials Inspection
Timeline
Manufacture Cell Culture Media Preparation Support
Bristol Myers Squibb
10.2023 - Current
Production Technician/Room Lead
Sanofi Pasteur
07.2019 - 03.2022
Production Artist
Outsourcing USA
01.2013 - 12.2024
Manufacturing Technician/Manpower Supervisor
Sanofi Pasteur
01.2010 - 08.2018
Production Technician
Sanofi Pasteur
Associate of Science Degree in Visual Communications -
Lehigh Valley College
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