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Sr. Lab Instrument Qualification / Validation Specialist

Foster City, CA
Sr. Lab Instrument Qualification Validation Specialist

Type of role: Contract (Onsite 2-3 days per week is mandatory)
Duration: 12-36+ months
Hourly pay rate: DOE (C2C, W2, or 1099 permissible)
Location: Foster City, CA 94404

Our customer is seeking a Senior Lab Instrument Validation Engineer who is well versed in laboratory Instrument processes within a Pharmaceutical environment. Must have hands-on experience in Lab Instrument Qualification. LabX experience is a big plus.  You will be primarily responsible for planning, leading, and executing validation efforts for standalone Lab Instrument Software systems.
 
Must have experience in the following:
  • Responsible for planning, scheduling, and executing validation efforts for LabX (previous experience with LabX system is a big plus).
  • Ensures validation is being performed per established procedure, review validation documentation, and coordinating between direct groups for the same.,
  • Identify intended use of laboratory instrument, develop qualification deliverables per current procedure and standards, and coordinate validation  activities between vendor, cross functional teams and users.
  • 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 mapping and bringing consistency to the  instrument lifecycle globally,  from supporting purchase to instrument validation to decommissioning documentation.
  • Plan, lead, and execute the standardizing of validation efforts for standalone Lab Instrument Software systems.
  • 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.

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