Pharmaceutical Process Validation Engineer

1 day ago


North Chicago, Illinois, United States Sterling Engineering Full time
Job Description

In this role, you will be responsible for ensuring that all equipment, facilities, and utilities meet the necessary regulatory requirements. This includes developing and implementing commissioning and qualification plans, as well as conducting risk-based evaluations and participating in FMEA processes.

Key Responsibilities:
  • Develop URS, FS, DQ documents and qualification protocols (IQ/OQ/PQ) to ensure compliance with 21CFR Part 210 and 211, as well as adherence to ICH Q7.
  • Execute and/or provide support during protocol executions.
Preferred Education/Skills:
  • Bachelor's or Master's degree in Engineering, Science, or a related field.
  • 3+ years of experience with commissioning, validation, and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach.
Average Salary: $95,000 per year.

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