Mario Montenegro
Imperial Beach,CA
Summary
Results-driven Manufacturing Technician with over 7 years of experience in the biotech, pharmaceutical, and medical device sectors. Expertise in executing downstream processes and clean-in-place operations, consistently ensuring compliance with cGMP regulations. Proven track record of enhancing production efficiency while maintaining the highest quality standards, contributing to overall operational excellence. Committed to leveraging technical skills and industry knowledge to drive continuous improvement and support organizational goals.
Overview
10
10
years of professional experience
Work History
EDM Operator
Aerotek
03.2026 - Current
- Perform equipment set-up, operation, and in-process inspection to accomplish assigned task(s).
- Manufacture and assemble of medical devices (Emitters for catheters) following specific procedures and manufacturing instructions.
- Maintained high quality standards for finished products through regular inspections and adjustments to the machines.
- Participated proactively in regular team meetings contributing valuable insights towards achieving departmental goals.
- Understand travelers/routers, how to identify materials, use a microscope and use production/inspection tools and equipment needed for product builds.
- Operated EDM machines to produce high-precision components per specifications.
- Monitored production processes, ensuring compliance with safety standards and quality control measures.
- Conduct product assemblies, with use of hand tools, following blueprints and ensuring quality standards with the use of microscope
- Trained new team members on machine operation and safety protocols, fostering a collaborative work environment.
Sr. Manufacturing Technician
Pacira Pharmaceutical
02.2022 - 08.2025
- Executed downstream processes, including filtration, centrifugation, and product recovery, ensuring product quality and compliance.
- Performed clean-in-place (CIP) and sterilization-in-place (SIP) operations.
- Prepared equipment and clean room for bulk manufacturing setup.
- Operated automated control systems and troubleshot equipment.
- Assembled filters for integrity testing and monitored autoclave loading cycles per SOP.
- Maintained batch records and performed data entry to support regulatory compliance and traceability.
- Handled raw materials, buffers, and solutions, strictly adhering to quality standards to uphold product integrity.
- Maintained production areas in a constant state of CGMP readiness.
Sr. Machine Operator
Bioduro-Sundia Pharmaceutical
11.2017 - 01.2022
- Operated and monitored tablet presses and capsule filling machines to ensure optimal performance.
- Executed blending, granulation, compression, encapsulation, and coating processes to meet production targets.
- Manufactured solid, liquid, and semi-solid dosage forms according to specifications.
- Completed GMP documentation, ensuring accuracy in batch records and data entry.
- Performed packaging and labeling operations for tablets and capsules, maintaining strict compliance with GMP standards.
- Followed standard operating procedures to maintain compliance with quality standards.
- Prepared clinical trial materials for phase 1 and phase 2 studies with thorough service.
- Conducted setup, operation, troubleshooting, disassembly, and cleaning of manufacturing equipment.
Machine Operator
Dexcom
07.2017 - 11.2017
- Operated hand tools, microscopes, and production equipment according to standard procedures.
- Ensured compliance with Good Manufacturing Practice (GMP) guidelines, upholding standards for quality and safety.
- Assembled products according to technical drawings and verbal instructions, ensuring precision and quality.
- Ensured transparency regarding activities affecting product quality or patient safety.
- Maintained clean and organized work environment to support team efficiency and streamline production processes.
Machine Operator
Alere
07.2016 - 05.2017
- Operated semi-automated machinery, ensuring precise part placement and performance monitoring.
- Conducted routine machine maintenance and cleaning before and after shifts to maintain optimal performance.
- Inspected components and assemblies to identify defects and ensure quality compliance.
- Utilized Camstar (MES) for accurate documentation of production activities and system logs.
- Coordinated work instructions with team members to improve workflow efficiency.
- Assisted technicians and materials clerks to streamline operations and minimize downtime.
Education
High School Diploma -
Zama American High School
Japan2009
References
Available on Request
Timeline
EDM Operator
Aerotek
03.2026 - Current
Sr. Manufacturing Technician
Pacira Pharmaceutical
02.2022 - 08.2025
Sr. Machine Operator
Bioduro-Sundia Pharmaceutical
11.2017 - 01.2022
Machine Operator
Dexcom
07.2017 - 11.2017
Machine Operator
Alere
07.2016 - 05.2017
High School Diploma -
Zama American High School