Carlos M. Alvarez Barbosa
Mayaguez,Puerto Rico
Summary
Enthusiastic industrial biotechnologist in process of also becoming an engineer. Eager to contribute to team success through hard work, attention to detail, and excellent organizational skills. Clear understanding of procedures and serious experience in regulated environment in Pharmaceutical and Medical Device Industry. Motivated to continue improving and executing project management skills in professional environment.
Overview
9
9
years of professional experience
Work History
Jr. Research Scientist - Sterility Assurance
Fresenius Kabi
San German, Puerto Rico
03.2021 - Current
- Validated/project managed Fedegari Autoclaves Qualification, THEMA4 CSV and cycle development studies (moist heat sterilization) for drug solutions as part of product/technology transfer projects.
- Executed and well experienced with moist heat sterilization validation process using wireless probes (data loggers), chemical integrators and biological indicators.
- Experienced with autoclave parameter and cycle programming, troubleshooting and sterilization cycle design.
- Redacted protocols, final reports, and FMEA for sterilization validations.
- Conducted statistical analysis for sterilization process.
- Completed validation and project management of new full scale Microbiology Laboratory implementation for drug solution testing and submitted to FDA as part of product transfer project.
- Created budget/capital expenditure proposals, Gantt Chart, resource allocation, critical paths/risks and requirement definition for new/on-going projects.
- Redacted and reviewed SOP's for Microbiology and Sterilization processes.
- Supported pharmaceutical water system implementation project for water for injection.
- Interplant continuous communication and support for project status and product transfer initiatives.
- Supported functional teams in product transfer planning, requirement definition and SOP review.
Validation Specialist
Fresenius Kabi
San German, Puerto Rico
08.2020 - 02.2021
- Validation Lead/Project Manager of new full scale Microbiology Laboratory for drug analysis submission as part of product transfer project including: CSV's Life Cycle GAMP5 Approach (viewLinc, ValSuite, PharmSpec, EndoScan, LIMS), lab equipment, autoclave, facility qualification, and method transfer/validations. Supervisory experience.
- Well experienced in microbiology validations, protocol/report generation and GAP Assessments.
- Executed GAP Assessments against USP/ISO Standards and global procedures.
- Managed budget, expenses, supplier/outsourcing coordinations and Change Control (TrackWise System).
- Collaborated designing of Microbiology and Chemical Laboratory Areas.
- Continuous communication of project status, issues and resolution strategies with functional groups and upper management.
QA COOP
Fresenius Kabi
Maricao, Puerto Rico
08.2019 - 07.2020
- Prepared, lead, and coordinated validation protocols for microbiology and chemical lab equipment (e. g. refrigerators, depyrogenation oven, HPLC).
- Executed microbiological tasks such as sterilization, environmental testing, and other microbiology techniques.
- Developed and initiated capital expenditure project for automated microorganism identification and avoid expenses from outsourcing.
- Assisted in quality non-conformance investigations.
- Executed change control, FMEA's, EHS Assessments and other validation related tasks.
Artisan - Business Owner
Prowoods Artesanía Puertorriqueña
Arecibo, Puerto Rico
08.2015 - Current
- Production of wooden artifacts (e. g. dominoes, musical instruments, plaques, notebooks, other items).
- Continuous improvement of production process reducing time and material cost.
- Employed design techniques such as pyrography, engraving and painting.
Education
Bachelor of Science - Chemical Engineering
Polytechnic University of Puerto Rico
San Juan, PR2024
Bachelor of Science - Industrial Biotechnology
University of Puerto Rico - Mayaguez
Mayaguez, PR07.2020
Skills
- Fully Bilingual Spanish/English
- Teamwork enthusiast and proven leadership
- Interdisciplinary
- Pro-active and problem solving skills
- Data Integrity and self-training efficient
- Proficient in Microsoft Apps (Word, PPT, Excel, Project, Outlook, Teams) and Minitab
- Time and resource/budget management
- Product and technology transfer experience
Leadership Experience
- Centro ESPIBI Board of Directors Secretary | Dec 2019 - Current (Member since Summer 2018)
- Phi Sigma Alpha Fraternity Secretary of Admissions | 2018 - Current
- Scuba Dogs Society Coast Captain | 2015-2019
- Boy Scouts of America Leadership Positions (local and national) | 2005-2018
- UPRM Concrete Canoe Team Treasurer and Construction Manager | 2016-2017
Timeline
Jr. Research Scientist - Sterility Assurance
Fresenius Kabi
03.2021 - Current
Validation Specialist
Fresenius Kabi
08.2020 - 02.2021
QA COOP
Fresenius Kabi
08.2019 - 07.2020
Artisan - Business Owner
Prowoods Artesanía Puertorriqueña
08.2015 - Current
Bachelor of Science - Chemical Engineering
Polytechnic University of Puerto Rico
Bachelor of Science - Industrial Biotechnology
University of Puerto Rico - Mayaguez
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