Computerized System Validation Engineer I

Takeda UK

Social Circle, GA, USA
Base: $58,400.00 - $91,740.00; bonus/equity: short...
Bachelor's degree in engineering discipline
Experience in gmp regulated environment
Knowledge of fda, ich, iso, eu regulations
The role supports Takeda's mission by ensuring reliable and efficient engineering operations through rigorous validation practices

Job Summary

  • The role supports Takeda's mission by ensuring reliable and efficient engineering operations through rigorous validation practices.
  • Candidates will be responsible for designing, authoring, and executing commissioning, qualification, and validation studies for various engineering disciplines.
  • Takeda offers a comprehensive benefits package including medical insurance, 401(k) matching, and up to 120 hours of paid vacation.

Matching Summary

The role supports Takeda's mission by ensuring reliable and efficient engineering operations through rigorous validation practices.

Salary

Base: $58,400.00 - $91,740.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k), tuition reimbursement, paid time off

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering discipline
  • Experience in GMP regulated environment
  • Knowledge of FDA, ICH, ISO, EU regulations
  • Strong organizational and writing skills
  • Microsoft Office proficiency

Nice-to-have

  • Knowledge of ISPE and PDA guidelines
  • Experience with paperless validation systems
  • Familiarity with DeltaV, Honeywell, PLC systems
  • Direct experience with biotechnology processes
  • Project management software skills

Key Requirements

  • Bachelor's degree in Engineering or related field
  • 0-2 years of CQV/CSV experience desired
  • GMP regulated environment knowledge preferred

Work Rights

Not specified

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