Lab Instrument Validation Engineer

Location: Foster City, CA
Date Posted: 06-04-2018
Title: Lab Instrument Validation Specialist

Type of role: Contract
Duration: 12-24+ months
Hourly pay rate: DOE (C2C, W2, or 1099 permissible)
Location: San Francisco Bay Area

Our customer is seeking a Lab Instrument Validation Engineer who is well versed in laboratory Instrument/Equipment processes within a Pharmaceutical or Biotech environment. Experience with the following instruments needed: DSC & TGA
 
Must have strong experience within the following:
  • Responsible for performing validation of Laboratory Instrumentation by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
  • Responsible for the entire instrument lifecycle from supporting purchase to instrument validation to decommissioning documentation.
  • Responsible for developing and executing on validation plans according to approved procedures, collation of test results, and organizes data packages and maintains all documentation pertaining to validation.
  • Ability to compile and analyze validation data, prepare reports and makes recommendations for changes and/or improvements.
  • Well versed in Laboratory Instrument process, ability to provide guidance to management on what improvements need to be made. (Essential for this role)
  • May also investigate and trouble-shoot problems which occur, and determine solutions.
  • Support change management and manage existing lab systems.
  • Participates on cross-functional project teams with the support of Development, Quality, and other groups
  • Familiar with FDA guidelines for Instrument and Software validation.
  • Experience must come from a pharmaceutical, biotech industry with direct knowledge of FDA regulations including 21CFR Part 11.
  • Self-motivated, good communication, technical writing, presentation skills, detail oriented, analytical, and a team player.  
  • Minimum 6-8 years of validation in a pharma environment is required.
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