CSV Compliance Engineer

Do you have a strong understanding of clinical development and regulations, including GxP and CFR Part 11?

If you have extensive knowledge of life sciences research and development processes, including clinical supply chain functions, we want to hear from you. SQA is seeking an experienced CSV Compliance Engineer to work with a biotechnology client seeking New Drug Application (NDA) approval.

In this fast-paced environment, the ideal candidate will be self-directed within the framework of IT and corporate policies. If you thrive in small company environments, this is an opportunity to help implement IT systems in support of business initiatives.

Required experience and responsibilities include:

  • Maintaining the validated state of IT systems, ensuring compliance of global regulatory standards
  • Validation strategy and planning development as well as detailed script development
  • Producing artifacts, including traceability matrices and summary reports
  • Executing manual validation scripts and overseeing defect triage/management
  • Interacting with business teams and users to review requirements and develop a testing approach and validation plan
  • Extensive experience with GxP, 21CFR Part 11

Job ID: 1809-5629
SQA is an equal opportunity employer and supports workforce diversity.