Computerized System Validation Engineer I

Takeda

Social Circle, GA, USA
Base: $58,400.00 - $91,740.00; bonus/equity: short...
Bachelor's degree in engineering discipline
Gmp regulated environment experience
Commissioning and qualification studies
This role supports Takeda's mission by ensuring reliable and efficient engineering operations through rigorous validation practices

Job Summary

  • This role supports Takeda's mission by ensuring reliable and efficient engineering operations through rigorous validation practices.
  • The engineer is responsible for designing, authoring, and executing commissioning, qualification, and validation studies for facilities, utilities, and equipment.
  • Employees may work in controlled environments requiring special gowning and protective clothing to ensure product quality and safety.

Matching Summary

This 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), up to 120 hours paid vacation

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering discipline
  • GMP regulated environment experience
  • Commissioning and qualification studies
  • Validation of automation platforms

Nice-to-have

  • Knowledge of ISPE and PDA guidelines
  • Experience with paperless validation systems
  • Strong organizational and writing skills
  • Cross-functional team collaboration

Key Requirements

  • Bachelor's degree in Engineering or related field
  • 0-2 years experience in CQV/CSV
  • Knowledge of FDA, ICH, ISO, EU regulations

Work Rights

Not specified

Tailored Resume

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