Senior CSV Engineer

CSV San Francisco, California

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Description

Azzur Group San Francisco is looking for Senior Computer System Validation (CSV) Engineer to join our growing San Francisco team. Working with a multi-disciplinary team, the Sr CSV engineer will be able to solve a variety of routine and diffiucult technical issues following cGMP regulations and client’s standards. In this hands-on role, the Sr. CSV engineer will help establish the Quality IT Infrastructure program for the client’s facility. Experience with cGMP and FDA compliance is essential.

 

Essential Duties and Responsibilities

  • Work within the Quality Engineering group known as QEV (Quality, Engineering, Validation) as the Computerized System Validation (CSV) quality oversight. 
  • Work to establish a sound Quality IT Infrastructure program within the client’s facility
  • Ensure those systems are qualified for the transfer and maintained under future client requirements   
  • Assist in establishing the change control management and control processes.  Eg. (Snow, Veeva, KNEAT).  
  • Assist in establishing the qualification program for the Computerized system
  • Serve as a Quality representative on cross-functional and multi-site teams
  • Identify, recommend solutions & work on solutions to potential procedure, process, and system gaps and continuous improvement activities. 
  • Participate in the design and implementation of department and cross-functional initiatives.   
  • Apply basic theory and technical principles to address moderately complex problems.
  • Train current client personnel on CSV OT / GAMP 5 Quality

 

Required Experience

  • BS Engineering or related discipline.
  • Minimum 10 years CSV experience in the pharmaceutical and/or biotechnology industry is required.
  • 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:

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

 

This employer participates in E-Verify.

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