Senior Analytical Engineer

7 days ago


Thousand Oaks, United States Planet Pharma Full time

12 Month Contract (May extend or convert to permanent)

$45/hour W2


Top Requirements:

  • Bachelor's Degree and 5+ years of related experience
  • Experience with Analytical Equipment Troubleshooting
  • Experience with Commissioning, Qualification, and Validation of Analytical Equipment
  • Experience with Manufacturing Support


Position Summary:

  • The Senior Analytical Engineer will lead the troubleshooting, vendor support, commissioning, qualification, validation, decommissioning, and project work associated with a wide variety of analytical equipment that supports manufacturing.
  • Scope includes a wide range of devices such as Cell counters, metabolite analyzers, blood gas analyzers, osmometers, spectrophotometers, endotoxin analyzers, TOC analyzers, and filter integrity testers. The qualified candidate will work with the analytical team to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities.


Responsibilities:

  • Work cross-functionally with individuals and project teams in Analytical, Engineering, Instrumentation, and Manufacturing.
  • Determine technical coverage and proper integration different subsystems.
  • Create and execute to project plans and schedules.
  • Develop, execute, and review documents, qualification and validation plans and other related development documents for assigned projects.
  • Provide deep technical assistance for other support staff and operators using equipment. Support of different equipment.


Requirements:

  • BS in Engineering, Biotech, or Equivalent and previous experience in a biotech/pharmaceutical industry with focus on analytical equipment
  • 5 years current experience with analytical processes and procedures.
  • Experience leading projects from development through commissioning, qualification, validation, and/or decommissioning
  • Strong background in troubleshooting, root cause analysis, and vendor coordination
  • Must be capable of working on multiple projects in a deadline driven environment.


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