Jose Puello
Allentown,PA
Summary
Gowning-certified Aseptic Technician with experience in GMP-regulated sterile manufacturing and Grade A/B cleanroom operations. Skilled in operating aseptic filling systems, performing equipment setups and changeovers, and maintaining accurate GMP documentation. Detail-oriented and committed to quality, safety, and regulatory compliance.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Aseptic Technician
Thermofisher
08.2025 - Current
- Operated and maintained aseptic filling equipment in a GMP-regulated cleanroom environment, ensuring compliance with FDA and internal quality standards.
- Performed in-process and final product quality checks, identifying deviations and escalating issues in accordance with deviation and CAPA procedures.
- Executed aseptic techniques and gowning procedures in ISO-classified environments to minimize contamination risk and maintain sterility assurance.
- Accurately completed batch records, equipment logs, and production documentation in compliance with Good Manufacturing Practices (GMP).
- Reviewed sterility testing and environmental monitoring data for accuracy and completeness prior to submission.
- Conducted visual inspections of sterile finished products to ensure conformance with established specifications and quality requirements.
- Maintained clean, organized, and compliant sterile processing areas to support contamination control and operational readiness.
- Adhered to OSHA, FDA, and AAMI guidelines related to sterilization, safety, and aseptic processing.
- Collaborated with production, quality, and engineering teams to support efficient workflow and continuous improvement initiatives.
- Supported seamless shift transitions by communicating production status, equipment conditions, and quality concerns to incoming technicians.
- Familiar with sterile gowning procedures and brief exposure to Grade A/B cleanroom environments, maintaining adherence to aseptic controls.
- Skilled in operating aseptic filling equipment and assisting with high-quality drug product manufacturing.
Aseptic Filling
Sanofi
03.2025 - Current
- Experienced Aseptic Technician II with hands-on expertise in sterile drug product manufacturing within GMP-regulated Grade A/B cleanroom environments.
- Proficient in operating and monitoring automated aseptic filling systems, performing equipment setups and changeovers, and supporting high-precision manufacturing operations.
- Skilled in executing aseptic techniques, gowning procedures, and contamination control practices to maintain sterility assurance.
- Strong background in environmental monitoring support, validation activities, and adherence to FDA, OSHA, and internal quality standards.
- Highly detail-oriented with proven ability to maintain accurate GMP documentation, including batch records and equipment logs, while supporting safe and efficient production.
Landscaping Crew Leader
Quantum Green
03.2021 - 08.2024
- Managed a team of individuals, providing hands-on training to ensure efficiency and quality work.
- Proficient in operating and maintaining all necessary landscaping equipment.
- Skilled in safely driving and transporting equipment to job sites.
- Focused on team coordination, productivity, and maintaining high standards of landscaping services.
Librarian
Wilkes University
09.2020 - 05.2021
- Worked at the front desk of the college library, assisting students with book reservations, shelving, and maintaining an organized inventory.
- Provided guidance on locating books and accessing important library resources.
- Ensured a welcoming and efficient environment by addressing student inquiries and supporting daily library operations.
- Library Assistant
Picker
Amazon Warehouse
05.2020 - 08.2020
- Efficiently picked and scanned inventory items from bins, ensuring accuracy and timely preparation for packing and shipment.
- Collaborated with team members to maintain a smooth workflow and meet shipping deadlines.
- Demonstrated attention to detail and a strong commitment to quality control throughout the process.
Education
Some college - Criminal Justice
Strayer University
Virginia04-2026
Skills
- Aseptic technique and sterile processing in GMP-regulated environments
- Operation and monitoring of automated aseptic filling systems
- Equipment setup, changeovers, and calibration support
- Cleanroom operations with gowning procedures (Grade A/B exposure)
- Batch record documentation and GMP-compliant production logs
- Environmental monitoring support and participation in validation/qualification runs
- Visual inspections, in-process checks, and sterility test assistance
- Troubleshooting mechanical or process issues to maintain productivity
- Adherence to FDA, OSHA, and AAMI guidelines and SOPs
- Attention to detail, collaboration, and effective communication in team environments
Accomplishments
- Maintained accurate GMP batch records and supported critical production steps.
- Assisted with validation and process checks to ensure consistent product quality.
- Executed aseptic operations in Grade A/B cleanrooms, maintaining strict sterility and safety standards.
Certification
- Gowning Certified – Qualified to work in Grade A/B cleanroom environments
- Media Fill Completed – Demonstrated competency in aseptic technique
- SOP Training Completed – Completed all required standard operating procedure training
- Current GMP / Aseptic Process Trainings – Ongoing completion of required regulatory and operational trainings
Languages
English - Fluent
Spanish - Fluent
Timeline
Aseptic Technician
Thermofisher
08.2025 - Current
Aseptic Filling
Sanofi
03.2025 - Current
Landscaping Crew Leader
Quantum Green
03.2021 - 08.2024
Librarian
Wilkes University
09.2020 - 05.2021
Picker
Amazon Warehouse
05.2020 - 08.2020
Some college - Criminal Justice
Strayer University