Document Specialist

  • location: Lake Forest, IL
  • type: Contract
  • salary: $32.33 - $38.04 per hour

job description

Document Specialist

Job Title: Validation Engineer II

Job Summary

  • Primary tasks include Building out and execution of the R & D Instrument Periodic Review Plan.
  • Candidate will need to have knowledge of qualification in an FDA regulated environment.
  • Project management skills are a plus.
  • Candidate will be giving weekly status reports to the Manager, R & D Systems.
  • Candidate will also be interacting with existing team and engaging them in activities as needed.
Job Responsibilities

  • Review experience of existing systems with an emphasis in monitoring and maintaining GMP status is a big plus.
  • Knowledge of ER/ES Data Integrity is important as well.
  • All levels of Instruments and equipment will need to be addressed from Computerized analytical instrumentation to pH meters used in GMP activities. There are approximately 300 instruments and equipment that will need to be addressed.
  • Small project execution.
  • Troubleshooting/commissioning/validation.
  • Documentation generation (specifications, protocols, etc) Support of maintenance of operation equipment.
Education & Qualifications

  • BS or MS degree in engineering or other scientific background.
  • Should be familiar with bio-pharmaceutical equipment and must have good GMP knowledge.
  • Work well independently as well as in a team.
  • Years of Experience 3-5.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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