Francisco Ortiz De Jesús
Dublin,Ohio
Summary
Dynamic and results-driven engineering professional with over 13 years of experience in the medical devices, pharmaceutical, and biotechnology industries. Demonstrated expertise in project management, quality systems, process validation, and the implementation of emerging technologies. Proven track record of enhancing operations, incorporating new processes and technologies, and successfully leading complex projects to completion.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Commissioning and Qualification Senior Engineer & C&Q Lead (Interim)
Amgen Packaging Facilities
11.2022 - Current
- Spearheaded commissioning and qualification activities for new packaging line machines in Amgen's biotechnology facilities
- Managed integration runs and equipment validation to ensure seamless operation within the manufacturing infrastructure
- Led a team of engineers, technicians, and contractors in qualification and validation efforts
- Provided technical expertise as the SME for Auto-injector ATS Assembly Machines and Detrayer/Assembly/Labeling Machines.
- Pioneered new packaging line that met rigorous industry standards and customer expectations, from concept to launch.
Senior Engineer Process Development
Boston Scientific
12.2021 - 12.2022
- Led product transfer validation activities, providing technical guidance and implementing statistical approaches
- Developed and validated processes for Sealing, Hydration, and Laser Weld processes
- Managed process risk assessments and optimization strategies to improve manufacturing operations.
Senior Engineer Process Development
Amgen Biotechnology Limited
08.2020 - 12.2021
- Optimized inspection and packaging lines for new product introductions
- Led capital projects and machine characterization efforts to enhance process efficiency
- Ensured compliance with FDA and regulatory standards in all validation activities.
Senior Validation Engineer
Viant Medical
04.2020 - 08.2020
- Developed and validated processes for new combo product introductions, including needle dipping and capping machines
- Implemented Statistical Process Control (SPC) for various manufacturing processes, ensuring consistency and quality.
Quality Application Specialist (Quality Engineer)
Medtronic
01.2018 - 04.2020
- Managed product component remediation projects, ensuring process validation and compliance with regulatory standards
- Provided engineering support for manufacturing operations, focusing on product quality and process improvements
- Led process validation remediation activities and documented control changes.
Quality Application Specialist
Medtronic
06.2016 - 01.2018
- Developed new applications and technologies for process monitoring and validation
- Led engineering teams to implement new products and technologies in manufacturing.
Validation and Manufacturing Engineer (Contractor)
Medtronic
08.2014 - 07.2015
- Developed and validated new technologies for crimping and visual inspection processes
- Managed computerized system validations and process monitoring implementations.
Computer Validation Specialist
Abbot Ltd.
01.2012 - 01.2013
- Led validation projects for computerized systems in pharmaceutical manufacturing areas, ensuring compliance with FDA regulations.
Manufacturing Engineer
St. Jude Medical
11.2011 - 05.2012
- Developed and implemented an ESD Control Program to minimize product damage in production lines
- Led installation and operational qualification efforts for final testing machines on production lines.
Education
Master's Degree in Manufacturing Engineering -
Polytechnic University of Puerto Rico
Puerto RicoBachelor of Science in Electrical Engineering (BSEE) -
Inter American University of Puerto Rico (IUPR)
Skills
- C, Visual Basic, MatLab
- Minitab, MatLab, LabView, Sciemetric, SAP, Microsoft Office Suite, AutoCAD, and more
- Process Monitoring Systems, Crimping Machines, Sterile Pack Process, Laser Weld Processes
- Project Management: Proven ability to lead and manage projects from concept through completion
- Process Validation & Qualification: Extensive experience with process validation, including OQ/PQ, equipment qualification, and test method validations
- Technical Expertise: Proficient in Design of Experiments (DOE), Statistical Process Control (SPC), and risk assessment methodologies
- Leadership & Team Management: Strong leadership skills with experience mentoring and guiding engineering teams
- Emerging Technologies: Skilled in the implementation of new technologies, process optimizations, and product transfers
- Quality & Compliance: Deep understanding of cGMP, cGDP, and FDA regulations, ensuring compliance and quality in all operations
- Leadership skills
- Team Management
- Project Management
- Technical presentation
- Product Development
- Technical expertise
- Quality Control
- Staff Supervision
- Engineering Studies
- Process Development
- Coaching and Mentoring
- Key Performance Indicators
- System Integration
- Manufacturing Processes
- Teamwork and Collaboration
- Technical reporting
Certificationstrainings
- FDA Regulations Good Manufacturing Practices (cGMPs) Certification
- FDA Biotechnology cGMP Certification
- OSHA General Industry Regulations Certification
- Lean Six Sigma Green Belt Certification (In Progress)
- Computer System Validation Certification
- Process Validation/Computer System Validation Certification
- SAP Management Certification
References
Available Upon Request
Accomplishments
- Achieved [Result] by introducing [Software] for [Type] tasks.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Achieved [Result] through effectively helping with [Task].
- Supervised team of [Number] staff members.
- Achieved [Result] by completing [Task] with accuracy and efficiency.
- Collaborated with team of [Number] in the development of [Project name].
- Documented and resolved [Issue] which led to [Results].
- Resolved product issue through consumer testing.
Certification
- [Area of certification], [Company Name] - [Timeframe]
- Certified [Job Title], [Company Name] - [Timeframe]
- Licensed [Job Title] - [Timeframe]
- [Area of certification] Training - [Timeframe]
- [Area of expertise] License - [Timeframe]
Languages
Spanish
Native or Bilingual
English
Professional Working
Timeline
Commissioning and Qualification Senior Engineer & C&Q Lead (Interim)
Amgen Packaging Facilities
11.2022 - Current
Senior Engineer Process Development
Boston Scientific
12.2021 - 12.2022
Senior Engineer Process Development
Amgen Biotechnology Limited
08.2020 - 12.2021
Senior Validation Engineer
Viant Medical
04.2020 - 08.2020
Quality Application Specialist (Quality Engineer)
Medtronic
01.2018 - 04.2020
Quality Application Specialist
Medtronic
06.2016 - 01.2018
Validation and Manufacturing Engineer (Contractor)
Medtronic
08.2014 - 07.2015
Computer Validation Specialist
Abbot Ltd.
01.2012 - 01.2013
Manufacturing Engineer
St. Jude Medical
11.2011 - 05.2012
Master's Degree in Manufacturing Engineering -
Polytechnic University of Puerto Rico
Bachelor of Science in Electrical Engineering (BSEE) -
Inter American University of Puerto Rico (IUPR)
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