Quality Engineer Resume

SUMMARY

Juan Antonio Rodriguez is a Quality Engineer, with experience in validation of GMP equipment, distribution systems and processes for the pharmaceutical, biotech industry and medical device.
He is a hands - on person, very adaptable, persistent, teamwork oriented and individual, with a strong sense of maintaining an updated knowledge of FDA/industry regulations and standards as well as technical knowledge.

PROFESSIONAL EXPERIENCE

Confidential

Quality Engineer

Responsibilities:

Responsible for developing Process Validation Protocols for the Metal Injection Molding Processes, (CNC) Machining of Class III medical device, Wire Drawing Processes, Passivation, Acid Etching and Anodization.
Process improvement of the Passivation, Acid Etching and Heat Treatment Operations
Performs Process Capability Studies for the machining of dental screw implants.
Performs statistical analysis: Analysis of Variance (ANOVA in Minitab) to establish equivalence among different (manufacturer) molding machines.
Reviews Environmental Health and Safety Assessments
Schedules and coordinates the process validation activities
Evaluates Engineering Drawings and Manufacturing Control Instructions (MCIs)
Develop Quality Procedures

Confidential, La Verne, California

Validation Engineer I

Responsibilities:

Commissioning Lead responsible for managing and performing the commissioning activities for process and utility equipment under my responsibility.
Responsible for developing and executing commissioning protocols (IQ/OQ/PQ) for:
- Autoclaves
- Dry Heat Sterilizer
- Lyophilizers
- Clean (Pure) Steam System
  - Clean Steam Generators
  - Clean Steam Distribution
- Plant Air System
  - Compressors
  - Desiccant Dryers
  - Plant Air Distribution
- Clean Dry Air System
  - Distribution
- Nitrogen System
  - Storage and Distribution
- Water for Injection (WFI)
- DI Water
- Feed Water
Assists the execution of commissioning protocols for the Aseptic Filling Machine (filler line), Visual Inspection System and Vial Packaging Line
Assists the Automation commissioning of the equipment, processes and systems connected to the Process Control System (PCS) by:
- Developing and reviewing commissioning protocol from the PCS standpoint
Assisted the development of FMEA and CCAs for various systems
Supported HVAC protocol execution.

Confidential, Pomona, California

Validation Engineering

Responsibilities:

Designed and implemented a QMS ACE Software instance for confidential Pharmaceuticals.
Wrote Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test scripts for the validation of a QMS (ACE Software)
Performed Risk Assessment.
Led training of new Software Validation Engineer.

TECHNICAL SKILLS

Programs:

Language: