Elmer Fuentes Gonzalez
Urb. Villa Universitaria V18 Cll 14, Humacao, PR 00791
Summary
Motivated and results-driven Associate Manufacturing with 6 years of experience in pharmaceutical manufacturing processes. Passionate about continuous learning and sharing expertise to enhance team performance. Proven ability to troubleshoot equipment, optimize processes, and lead teams within GMP-regulated environments. Certified SME in multiple manufacturing lines, including aseptic filling, inspection and packaging processes. Highly organized, proactive, and eager to take on new challenges to achieve higher levels of responsibility and career advancement. Committed to driving efficiency, enhancing reliability, and supporting operational excellence.
Overview
6
6
years of professional experience
Work History
Associate Manufacturing II
Amgen Manufacturing Limited
04.2024 - Current
- Certified on all equipment in Filling Line 1420, including OPTIMA aseptic filling equipment, debagger, SKAN Isolator, Keyence inspection system, and other processes.
- SME in multiple equipment and processes for both Inspection Line 1308 and Aseptic Filling Line 1420.
- Identify process improvement opportunities to enhance equipment performance and efficiency.
- Perform troubleshooting and root cause analysis on mechanical issues to ensure efficient, compliant, and uninterrupted manufacturing operations.
- Support the maintenance team in daily activities for the 1420 filling line, ensuring operational reliability.
- Generate work orders to facilitate immediate equipment repairs and minimize downtime.
- Provide training on equipment operation and processes to enhance team performance and technical expertise.
- Act as team lead when required, optimizing headcount allocation to maximize production output.
Associate Manufacturing II
Amgen Manufacturing Limited
09.2021 - 04.2024
- Lead line 548 Changeover improvement project to reduce downtimes and optimize the changeover time.
- Develop overlapping strategies to optimize production time.
- Report daily status in different meetings.
- Document and analyze OEE System to determine the
downtimes major offenders of the line. - Review draft documents, SOPs, PTCs, FORMs, etc in CDOCS.
- ERP SAP transactions, goods issue and raw materials movements.
- Initiate minor deviations in TrackWise QMS.
- PAS|X Werum, eBR documentation, calculate RTE, submit SCADA to equipments, PMBR approvals, GMBR design validation with MES Team.
- Set up packaging equipment for operations (Dividella NeoTop 804, Sortimat, Groninger Labeler, CTM Cassette Testing Machine and Case Packer).
- SME in Operation of the Advisor System for Serialized and non serialized product, Assignment of product expiration date, product/material reconciliation, sampling process and SME in different equipments and others tasks.
Quality Assurance Technician
Eli Lilly And Company
11.2020 - 09.2021
- Manufacturing batch record review.
- Check, monitor, and approval of cleans in manufacturing rooms.
- Perform swabs sampling of equipment and rooms.
- Recollecting water sampling.
- Darwin LIMS.
Associate Manufacturing Process Technician
Amgen Manufacturing Limited - Kelly Services
09.2018 - 11.2020
- Set up packaging equipment for operations (Dividella NeoTop 804, Sortimat, Groninger Labeler, Cassette Testing Machine and Case Packer).
- PAS|X Werum, eBR documentation, calculate RTE, submit SCADA to equipments.
- ERP SAP transactions, goods issue and raw materials movements.
- SME in Operation of the Advisor System for Serialized and non serialized product, Assignment of product expiration date, product/material reconciliation, sampling process and SME in different equipments and others tasks.
Education
Bachelor of Science - Biotechnology
Pontifical Catholic University of Puerto Rico
Ponce, PR06.2018
Skills
- Good Manufacturing Practices
- Computer proficiency
- Leadership experience
- Quick learner
- Ability to work under pressure
- Support non-standard shift
- Self-motivation
- Teamwork
- Adaptability
- Knowledge of emerging technology trends
- Problem-solving abilities
Timeline
Associate Manufacturing II
Amgen Manufacturing Limited
04.2024 - Current
Associate Manufacturing II
Amgen Manufacturing Limited
09.2021 - 04.2024
Quality Assurance Technician
Eli Lilly And Company
11.2020 - 09.2021
Associate Manufacturing Process Technician
Amgen Manufacturing Limited - Kelly Services
09.2018 - 11.2020
Bachelor of Science - Biotechnology
Pontifical Catholic University of Puerto Rico
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