Yaxaira Pabellon Diaz
Caguas,PR,Puerto Rico
Summary
Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.
Overview
15
15
years of professional experience
Work History
Specialist Manufacturing, Process Owner
Amgen
07.2017 - Current
- Applied process expertise for Packaging Line 740, 742, 319, 322, 4125, 4126, and 617.
- Responsible for the manufacturing procedures of the assigned packaging lines to ensure all procedures reflect current operations.
- Assess as SME of process performance on the floor operations and review of performance data.
- Evaluate, plan, and implement solutions for process improvement opportunities.
- Perform FMEA analysis for assigned and other packaging lines as business needs.
- Participate and help lead cross-functional teams.
- Manage New Product Introduction project for the assigned packaging Lines to assess requirements for documentation, materials, training, and equipment modifications.
- Support implementation and project management for process or equipment modification projects.
- Manage Non-Conformance and CAPA/ CAPA EV in a timely manner.
- Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
- Support internal/external inspections.
- Support continues improvement project in alignment with AMGEN goals.
- In charge to present process flow description for internal/external visit for the assigned packaging line
Engineer
AMGEN
07.2015 - 06.2017
- SME as Manual Inspection Technique Expert (MITE) for AMGEN manual inspection process.
- In charge to oversight AGMEN manual Inspection Lines in compliance with cGMP and procedures.
- Monitor and audit parenteral manual inspection lines in compliance with sampling attributes (AQL inspection) and operators techniques.
- In charge of the monthly report of the oversight program to the manufacturing staff.
- Perform Ergonomic Oversight to the manual inspection technique
- Support as Data Verifier role in packaging reports.
- In charge of the One Point Lesson (OPL) for safety incidents for Inspection and Packaging employees.
Manufacturing Supervisor
Medtronic
07.2014 - 04.2015
- Manage and supervise staff of 15+ operators.
- In charge of headcount analysis for production increment.
- In charge to align and coordinate manufacturing schedule in compliance with manufacturing requirements.
- Develop and implement a cost reduction of 16 % of overtime per shift.
- Responsible of the clean room activities for sterile product.
- Supervise assemblers to comply with the manufacturing requirements expected for the monthly sterile product shipment.
- Provide support and technical knowledge to sterile area for new product introduction projects
- Lead and maintaining good communication between supply chain team, production management and post production team.
Regulatory Compliance / Validation Consultant
Bristol Myers Squibb
03.2014 - 07.2014
- SOP development and implementation for manufacturing equipment during validation process in solid dosage manufacturing industry (Roller Compactor, Bin Inverter, Tablet Coating equipment, Bin Washer, Bin Blender, material Isolator).
- Revised operational procedures and validations accordingly to ensure processes alignment and accuracy.
- Responsible for training employees in the new manufacturing equipment.
Validation Specialist
Pfizer
06.2012 - 11.2012
- Validation execution of installation, operational and performance qualification for manufacturing and utilities equipment in solid dosage manufacturing industry (Bin Blender, Dust Collector, Weighing equipment and facilities).
- Acquire knowledge on facilities blueprints interpretation.
- Support Manufacturing area to train operators in new validated equipment.
Process Engineer
Pfizer
08.2011 - 03.2012
- Responsible for evaluating existing manufacturing process and configuring system to improve sustainability and develop best practices within the production process.
- Responsible to maintain the solid dosage manufacturing area accord with the GMP, EHS and Quality requirements.
Sales and Service Engineer
EM Packaging
10.2010 - 07.2011
- Complete knowledge of various primary and secondary packaging and manufacturing equipments in pharmaceutical and biotechnology industry.
- Responsible to manage the communication between vendor and client.
- Responsible to establish appointments to understand the client requirements.
- Responsible to find the best equipment to the client necessity.
Process Engineering Coop Student
Eli Lilly
01.2009 - 07.2009
- Acquire knowledge in Packaging lines and equipment in solid dosage manufacturing industry (Filler and checkweigher).
- Perform a FLMA analysis for Filler and checkweigher equipment.
Education
Master of Science - Engineering in Manufacturing Engineering
Polytechnic University in Puerto Rico
Hato Rey, PR07.2015
Bachelor of Science - Mechanical Engineer
University of Puerto Rico - Mayaguez
Mayaguez, PR07.2010
Skills
CAPA/Complaint
Project management
Change Management
Process Documentation
Extensive knowledge manufacturing process
Performance Improvement
Operational Excellence
Operations Oversight
Timeline
Specialist Manufacturing, Process Owner
Amgen
07.2017 - Current
Engineer
AMGEN
07.2015 - 06.2017
Manufacturing Supervisor
Medtronic
07.2014 - 04.2015
Regulatory Compliance / Validation Consultant
Bristol Myers Squibb
03.2014 - 07.2014
Validation Specialist
Pfizer
06.2012 - 11.2012
Process Engineer
Pfizer
08.2011 - 03.2012
Sales and Service Engineer
EM Packaging
10.2010 - 07.2011
Process Engineering Coop Student
Eli Lilly
01.2009 - 07.2009
Master of Science - Engineering in Manufacturing Engineering
Polytechnic University in Puerto Rico
Bachelor of Science - Mechanical Engineer
University of Puerto Rico - Mayaguez
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