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Senior Computer System Validation Engineer

2 months ago

San Francisco, California, United States Azzur Group Full time
About the Role

Azzur Group is seeking a highly skilled Senior Computer System Validation (CSV) Engineer to join our team in San Francisco. As a key member of our Quality Engineering group, you will be responsible for ensuring the quality and integrity of our computerized systems.

Key Responsibilities
  • Develop and implement a sound Quality IT Infrastructure program within the client's facility.
  • Ensure that all systems are qualified for transfer and maintained under future client requirements.
  • Establish and maintain change control management and control processes.
  • Assist in establishing the qualification program for computerized systems.
  • Serve as a Quality representative on cross-functional and multi-site teams.
  • Identify and recommend solutions to potential procedure, process, and system gaps.
  • Participate in the design and implementation of department and cross-functional initiatives.
Requirements
  • BS Engineering or related discipline.
  • Minimum 10 years CSV experience in the pharmaceutical and/or biotechnology industry.
  • Experience with FDA compliance and cGMP is required.
  • Strong understanding of GAMP 5.
  • Ability to interpret Quality standards for implementation.
  • Experience with PLC.
  • Knowledge of IQ, OQ, PQ, RTM, FS, DS requirements.
  • Project management experience preferred.
  • Knowledge of cGMP environment experience preferred.
  • Ability to communicate clearly and professionally both in writing and verbally.
Azzur Core Values

We value individuals who embody the following core values:

  • Puts Others First.
  • Have the Courage to Take Action.
  • Take Personal Responsibilities.
  • Have Fun.