Enyeli Mena
South Melbourne,Australia
Summary
Accredited by Engineers Australia, I am a highly skilled Chemical Engineer with a Master's degree and over 5 years of experience in the medical devices and food-beverage industries. My expertise lies in sterilization and environmental management, with a strong focus on ensuring compliance with industry standards such as ISO: 11137, 11135, 14644, 13485, and 9001. I possess advanced proficiency in laboratory chemical analytics techniques and have led teams in EO sterilization chambers validation projects. As a bilingual professional fluent in both English and Spanish, I excel in data analysis and interpretation, coupled with exceptional problem-solving abilities.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Laboratory Technician (Specimen Reception)
4Cyte Pathology
Melbourne, Australia
08.2022 - Current
- Manage patient episodes, forms, and specimens including labelling, registration, aliquoting, dispatching, storing, and preparing samples for analysis.
Sr. Quality Operations Supervisor
Ecolab
Santo Domingo, Dominican Republic
11.2021 - 07.2022
- Ensured final product quality by monitoring compliance with quality policies and ISO 13485 standards
- Lead projects through multidisciplinary teams to improve quality KPI (FPY - First pass yield / NCR)
- Supervised quality coordinators, inspectors, technicians, and other personnel
- Followed up on preventive and corrective actions from the NCR program and process non-conformities.
Microbiologist - Sterilization I
Medtronic PLC
Santo Domingo, Dominican Republic
09.2019 - 07.2021
- Ensured compliance of critical areas (clean rooms ISO class 8 & 9) with ISO 14644
- Led the microbiology and chemistry laboratory activities, including invitro, moisture, EO residual, particulate, air, and surface microbiology testing
- Facilitated sterilization chamber validation and parametric and BI release of sterilization cycles (ISO 11137)
- Conducted root cause investigations for laboratory test deviations and clean room monitoring, implementing corrective and preventive actions (CAPA)
- Collaborated on microbial identification and sterilization chamber performance qualifications (MPQ, PPQ)
- Conduct equipment and process validation/ Achievement: FTIR Validation
- Executed equipment and process validation, including FTIR validation
- Performed and supervised EO residual tests (ISO 11135)
- Annual recertification of critical areas (clean rooms)
- Conducted annual recertification and semiannual trend analysis of clean rooms using Minitab or Excel
- Managed the bacterial endotoxin and bioburden quarterly product sampling program, documenting and approving final test reports through LIMS.
Materials Quality Supervisor
Quala S.A
Santo Domingo, Dominican Republic
05.2019 - 09.2019
- Supervised quality laboratory personnel and tests on raw and packaging materials
- Conducted audits of good warehouse practices
- Managed non-conformities and shelf life of raw and packaging materials
- Developed alternate suppliers.
Intern
Polymer Char
Valencia, Spain
06.2018 - 12.2018
- Conducted research and development activities for polymer characterization equipment
- Prepared samples for equipment testing and analyzed data.
Chemical Analyst
Mercasid, S.A.
Santo Domingo, Dominican Republic
10.2015 - 08.2017
- Led physicochemical analyses of margarines and oils
- Oversaw production line releases and microbial analysis of products (margarines, milk).
Process Engineer/ Quality Assurance Engineer
Sabores Cosco Dominicano
Santo Domingo, Dominican Republic
10.2014 - 10.2015
- Managed plant production plans and led HACCP program and recertification
- Coordinated production plans and implemented operational processes
- Achieved HACCP certification and developed quality standard procedures.
Education
Master’s in Chemical Engineering -
Valencia University
01.2019
Bachelor’s in Chemical Engineering -
Autonomous University of Santo Domingo (UASD)
01.2015
Technical Bachelor in Dairy Products Processing -
Maximo Gomez Polytechnic Bani
01.2009
Skills
- Problem-solving
- Data analysis
- Team leadership
- Management
- Organization
- Dependability
- Strong communication skills
- Deadline prioritization
- English
- Spanish
- ISO: 11137
- 11135
- 14644
- 13485
- 9001
- Laboratory skills
- Gas chromatography
- Titration
- FTIR
- Sterility testing
- Good Manufacturing & Laboratory Practice (GMP) (GLP)
- Computing skills
- Microsoft Office (Word
- Excel
- PowerPoint
- Visio
- Project)
- Minitab
- ERP (BPCS)
- LIMS
- SAP
- Power BI
Certification
- Project Management Diploma - IHBC
- Advanced Excel Course - Unapec
- Operations Management – Quality GB
- Statistical Process Control – CCF San Valero Institute
- Fundamentals of Supervision – Infotep
- Introduction to the Management System ISO 9001:2008 – Infotep
References
- Anastasiia Zelenova, Productio Sr. Supervisor at Waverley Insdustries, +61 422216721, Ozzecoat@gmail.com
- Cesar Martinez, Sr Microbiologist – Sterilization at Medtronic, +1 829 296 6622, Cesar.ivan.martinez@medtronic.com
- Mathhew Pagonis, Laboratory and SraSupervisor at 4Cyte Pathology, +61 421825118, matthew.pagonis@4cyte.com.au
- Thomas Plunkett, Medical Scientist at 4Cyte Pathology, +61 452123318, Thomas.m.plunkett.91@gmail.com
Timeline
Laboratory Technician (Specimen Reception)
4Cyte Pathology
08.2022 - Current
Sr. Quality Operations Supervisor
Ecolab
11.2021 - 07.2022
Microbiologist - Sterilization I
Medtronic PLC
09.2019 - 07.2021
Materials Quality Supervisor
Quala S.A
05.2019 - 09.2019
Intern
Polymer Char
06.2018 - 12.2018
Chemical Analyst
Mercasid, S.A.
10.2015 - 08.2017
Process Engineer/ Quality Assurance Engineer
Sabores Cosco Dominicano
10.2014 - 10.2015
Master’s in Chemical Engineering -
Valencia University
Bachelor’s in Chemical Engineering -
Autonomous University of Santo Domingo (UASD)
Technical Bachelor in Dairy Products Processing -
Maximo Gomez Polytechnic Bani
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