Alcides Saavedra

About Alcides Saavedra

Highly skilled professional with a demonstrated history in pharmaceutical industry. Extensive knowledge in Commissioning, Qualification, Validation and Automation of Instrumentation and controls. Experience in Regulatory compliance with a Bachelor of Science in Computer Science and Electronics. Track record in Engineering, Quality, Validation and Manufacturing Process Controls for U.S. Food and Drug Administration (FDA) compliance.

Experience

1. Instrumentation and Control Engineer

   Takeda

   Oct 2017 — Present · Los Angeles, CA, US

   In charge of Managing projects for startup and commissioning of manufacturing equipment for production purposes. Responsible for continuously provided of manufacturing equipment using Delta V, PLC – Allen Bradley and Building Automation with equipment using Siemens ApogeeVerified P & IDs, turn over Packages (TOP), bill of materials (BOM), welding certificates, calibrations and Specifications of all WFI systems, RO systems, HVAC Systems, Process Vessels, Heat Exchangers, Temperature control module systems, CIPs, and oversee all Manufacturing equipment were configured as specified per design for the Facility.Support and manage all Distribute Control System (DCS) by troubleshooting, repairs and edits to parameters and instrumentation devices.Support management with CAPAS, Investigations, participate in GAMBA walks, and support FDA and Internal Audits. Responsible for training employees in Good Manufacturing Principles (cGMP), Calibration operation procedures, Corporate Operating procedures and all OSHA guidelines.Prepared technical reports, Deviations, Out of Tolerances reports, Out of Specifications and Calibration investigations with relations to product impacts.

Education

• DeVry University

  Bachelor of Science, Technical Management

  2003 — 2005

• DeVry University

  Associate of Apply Science, Electrical and Computer Technology

  2001 — 2003

Skills

• Computer System Validation
• Troubleshooting
• Quality Assurance
• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Instrumentation
• Change Control
• Engineering
• Commissioning
• Standard Operating Procedure (Sop)
• Gmp
• Automation
• Sop
• Fda
• Validation
• Testing
• Calibration
• Documentation