Reggie Ordonio

**** ****** **** *****, **. *****

209-***-**** – ad4s7w@r.postjobfree.com

OBJECTIVE:

Acquire a position in Research and Development Engineering Department, Calibration, Department, QA Management or Manufacturing Department where my skills and experience can be fully utilized. A strong contributor that will provide the organization with practical experience and the ability to meet the goals and future needs the organization.

Skills:

Support all projects needs to completion, and to successfully produce quality products in timely manner. Demonstrates great deal of respect to all personnel doing whatever work is assigned without complaint.

Undertake chemical aspects of drug handling and reconciliation

Maintain excellent coordination and good relations between customers and fellow employees

PROFESSIONAL SUMMARY:

In depth knowledge of GMP, GLP, GCP and FDA requirements.

Twenty-four years of experience in Medical Devices and Pharmaceutical Companies

Focused professional skilled in equipment inspection and calibration. Adheres to technical specifications to meet standard maintenance requirements.

EXPERIENCE:

Durect Corporation: (03/1999-12/2023)

Sr. R&D Technician/ Sr. Mfg. Technician/ Calibration Coordinator

Support the needs of design and process of both R&D and Manufacturing engineers who are designing, developing, prototyping, testing and manufacturing medical products.

Perform assembly of implantable device for drug delivery to be used for animal and clinical studies.

Test device subassemblies with protocol instructions and qualify before product assembly.

Train manufacturing assemblers on processes, techniques and how to operate manufacturing equipment.

Work in environments such as R&D prototyping and manufacturing production.

Operate various types of equipment such as Instron machine, Micro-Vu, Spectrophotometer, Lyophilizer machine, Ovens, Autoclaves, Washers, Sonicators, Balances, Schmidt Press, Melt Indexer, Rheometers, PH Meter, Sealer, Hot Box, EFD machines, Light Curing Machine, etc.

Maintain manufacturing facility and equipment in compliance with company procedures and regulatory requirements ensure no major findings during inspection; ensuring training files are current at all times.

Providing materials and management support with materials and supplies dispensing and warehouser maintenance.

Provide calibration support and help maintain company equipment and instrument compliance per company procedures and regulations.

Perform basic preventive maintenance on some equipment in the cleanroom.

Perform In-Process Line Clearance or GMP manufacturing activities.

Participate in internal audit as required.

Dispense, Dispose and inventory of Controlled substances.

Support Microbiology Department with water sampling and environmental monitoring.

WL Gore ans Associates (01/ 1998- 03/ 1999

Sr. R&D EngineeringTechnician

Assembling catheters from start to finish.

Perform complex tests ( Balloon Burst Test, Tensil Test and Pull Test using insertion machine and Cycle test ).

Perform Folding, Lacing and Sewing Processes for the stent catheter.

Deals with vendors and machinists for parts and tooling needed for assembling prototype catheters.

Help engineering preparing catheters for animal and clinical studies.

Endotex Interventional Systems 04/ 1997- 12/ 1997

Manufacturing Technician

Perform assembly and build activities including etching process, soldering, epoxy curing and manipulation of small parts under a microscope.

Utilize custom fixtures and equipment for device assembly and test; recommend and initiate improvements.

Support maintenance of lab equipment such as vacuum pump, balances and laboratory hoods.

EDUCATION

Bachelor of Science In Elementary Education March 1992

Philippine Normal University – Philippines

Medical Office Assisting

Ohlone College Fremont, CA. May 1997

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