Senior Validation Specialist

4 days ago


Colorado Springs, Colorado, United States Philips Full time
About the Role

As a Senior Validation Engineer at Philips, you will play a critical role in ensuring the labeling software tools meet the highest standards of quality and compliance. Your expertise will be instrumental in defining user needs and requirements, documenting key software functionality, and understanding relevant regulations such as 21CFR part 11 compliance.

Key Responsibilities
  • Understanding system functionality, technical requirements, and overall system architecture/integrations in a rapidly evolving software landscape.
  • Defining user needs and requirements, and documenting key software functionality during development/configuration.
  • Understanding relevant regulation including 21CFR part 11 compliance, key standards (e.g. ISO 15223-1, ISO 15415, ISO 15416, etc.), and defining the impact to needed software functionality and validation.
  • Assist operations team with the design and validation of labeling processes throughout the labeling lifecycle.
Requirements

We are seeking a highly motivated and detail-oriented individual with a strong background in software or system validation in regulated environments. Key qualifications include:

  • Bachelor's Degree in computer science, systems engineering, or equivalent.
  • 5+ years of experience in software or system validation in regulated environments.
  • Detail oriented, self-motivated, well organized, excellent written and verbal communication, and the ability to take high level goals or requirements and translate them to individual tasks/deliverables.
Salary Information

The estimated salary for this position is $92,000 to $150,000 per year, depending on location and experience.



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