Edgardo Gonzalez

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Project Engineer

Edgardo has 21 years of experience in engineering and manufacturing in the pharmaceutical, medical device and diagnostics industry. Responsibilities have included installation, commissioning, and validation of large scale manufacturing equipment. Edgardo is highly skilled in operation and trouble shooting PLC systems.

 

EXPERIENCE…
  • Performed turn key validation of equipment, utilities and facilities for several pharmaceutical, medical device and diagnostics companies.
  • Supervised engineers and technicians for a medical device manufacturing engineering department.
  • Managed several production areas includuing bulk manufacturing, specialized manufacturing, filling, lyophilization, and glass departments.
  • Key player in start-up of a diagnostic manufacturing site in Puerto Rico. Installed and validated automated assembly/filling lines. Developed procedures and trained production, engineering and maintenance personnel.
  • Developed equipment functional specifications, prepared capital appropriation justification, installed and validated new equipment.
  • Developed operating and maintenance procedures and programs for manufacturing processes and equipment. Increased process efficiency and reduced on-line rejects.
  • Installed and validated high speed equipment (filler, capper, labeler, automated packaging lines).
  • Installed, validated and released to production automated tablet packaging line.
  • Modified and retrofit existing equipment to meet new filling and packaging components specifications.
POSITIONS HELD…
  • Project Engineer – BioTeknica, Inc.
  • Project Engineer – Dade Behring, Inc.
  • Manufacturing Engineer – Dade International, Inc.
  • Sr. Staff Engineer – Baxter Diagnostic, Inc.
  • Associate Engineer – Baxter Diagnostic, Inc.
  • Production Superintendent – Baxter Diagnostic, Inc.
  • Manufacturing Section Head – American Dade, Inc
  • Manufacturing Supervisor – American Dade, Inc.
EDUCATION…
  • B.S., Chemical Engineering – Mayaguez University, Puerto Rico
CONTINUING EDUCATION…
  • Allen Bradley PLC5 and SLC500 Systems programming and troubleshooting
  • ADEPT Robotic System programming and troubleshooting
  • Validation Workshop
  • SPC
  • ISO 9000