Validation Engineer

Fresenius Kabi

Base: $60,966 - $85,694; bonus/equity: not specifi...
Not specified (assumed to be onsite based on job responsibilities)
Cgmp regulatory requirements knowledge
Equipment commissioning and qualification execution
Statistical analysis and data recording skills
Fresenius Kabi is seeking a Validation Engineer responsible for equipment/system initial validation and requalification, with a focus on regulatory compliance and performance enhancement. Candidates should have a strong understanding of cGMPs, effective report writing skills, and the ability to analyze data. The position offers competitive salary and comprehensive benefits

Job Summary

  • The role is responsible for providing technical support to operations regarding equipment initial validation and requalification.
  • Candidates must have a comprehensive understanding of cGMPs and be certified to enter controlled areas of the plant.
  • The position offers a competitive salary range, comprehensive health benefits, and a 401(k) plan with company contributions.

Matching Summary

Match Score: 75

Fresenius Kabi is seeking a Validation Engineer responsible for equipment/system initial validation and requalification, with a focus on regulatory compliance and performance enhancement. Candidates should have a strong understanding of cGMPs, effective report writing skills, and the ability to analyze data. The position offers competitive salary and comprehensive benefits.

Salary

Base: $60,966 - $85,694; Bonus/Equity: Not specified; Benefits: 401(k), medical, dental, vision, paid vacation

Skills & Requirements

Must-have

  • cGMP regulatory requirements knowledge
  • equipment commissioning and qualification execution
  • statistical analysis and data recording skills
  • clear technical report writing ability
  • controlled area certification eligibility

Nice-to-have

  • experience with deviation investigations
  • team collaboration on system improvements
  • presentation skills for regulatory agencies

Key Requirements

  • Comprehensive understanding of cGMPs
  • Certification for Controlled Areas (Grade D, C, B/A)
  • Ability to write clear and accurate reports
  • Basic understanding of statistical analysis

Work Rights

Not specified

Tailored Resume

Cover Letter