Computer Systems Validation Automation Specialist

2 weeks ago


Canton, Georgia, United States Saxon Global Full time
Job Title: Computer System Validation Automation Engineer

Job Summary:

We are seeking a highly skilled Computer Systems Validation Automation Engineer to join our team at Saxon Global. As a key member of our CSV team, you will be responsible for ensuring the validation of computer systems in a cGMP pharmaceutical facility, adhering to FDA regulations.

Key Responsibilities:

  • Develop and implement validation protocols for automation control systems, manufacturing, and IT systems.
  • Ensure compliance with ASTM2500, GAMP5, Data Integrity, and 21 CFR Part 11 regulations.
  • Collaborate with the CSV team to identify and address validation gaps.
  • Provide technical expertise in automation control systems and manufacturing methodologies.

Requirements:

  • 5+ years of direct Computer Systems Validation experience in a cGMP pharmaceutical facility.
  • Knowledge of automation control systems, manufacturing, and IT systems methodologies.
  • Bachelor's degree in Chemical Engineering, Computer Engineering, Biological Science, or a technical equivalent.

Desired Skills:

  • Working knowledge of Kneat validation software.
  • Knowledge of Drug Substance Manufacturing (DSM), Drug Product (DP), and/or Finished Goods Manufacturing.

About Saxon Global:

Saxon Global is a leading provider of staffing solutions for the life sciences industry. We are committed to delivering exceptional service and expertise to our clients and candidates.



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