Computerized System Validation Engineer I

Takeda

Social Circle, GA, USA
Base: $58,400.00 - $91,740.00; bonus/equity: short...
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Bachelor's degree in engineering discipline
Experience in gmp regulated environment
Knowledge of ispe, pda, fda, ich, iso regulations
** Takeda is seeking a Computerized System Validation Engineer I to support engineering operations at their Social Circle, GA facility. The role involves ensuring quality, safety, and performance standards in production processes, primarily through commissioning, qualification, and validation studies. **

Job Summary

  • This role supports Takeda's mission by ensuring reliable and efficient engineering operations through rigorous validation practices.
  • The engineer will independently design, author, execute, and summarize commissioning, qualification, and validation studies for various disciplines.
  • Employees are eligible for comprehensive benefits including medical, dental, vision, 401(k) match, and up to 120 hours of paid vacation.

Matching Summary

Match Score: 75

** Takeda is seeking a Computerized System Validation Engineer I to support engineering operations at their Social Circle, GA facility. The role involves ensuring quality, safety, and performance standards in production processes, primarily through commissioning, qualification, and validation studies. **

Salary

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

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering discipline
  • Experience in GMP regulated environment
  • Knowledge of ISPE, PDA, FDA, ICH, ISO regulations
  • Strong organizational and communication skills
  • Proficiency in Microsoft Office suite

Nice-to-have

  • Experience with Honeywell Delta V and PLC systems
  • Knowledge of paperless validation tools
  • Familiarity with Microsoft Project and Visio
  • Experience with protein purification processes
  • Background in automation platforms like Siemens XFP

Key Requirements

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

Work Rights

Not specified

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