Computer Systems Validation Automation Specialist
2 weeks ago
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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