Validation Engineer

5 days ago


Austin, Texas, United States Abbott Full time
Job Description

We are seeking a Senior Validation Quality Engineer to join our team in Austin, TX. As a Senior Validation Quality Engineer, you will provide quality support and oversight on product, process, and equipment related changes and implementations (validation & change control).

Main Purpose of Role

This position is responsible for providing quality support and oversight on product, process, and equipment related changes and implementations (validation & change control). Specifically:

  • Provide quality support and oversight (approval) of process and equipment validation and change control records and activities.
  • Ensure consistent deliver of high-quality documents, processes, products, and processes.
  • Review documentation for accuracy, clarity, consistency, completeness, and compliance to internal and external requirements.

Qualifications

  • Bachelor's Degree in Engineering or Technical Field or an equivalent combination of education and work experience.
  • Minimum 5 years experience in medical device/pharmaceutical manufacturing.
  • Demonstrated supervisory experience preferred.
  • Validation experience and demonstrated use of Quality tools/methodologies.
  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.

Benefits

  • A fast-paced work environment where your safety is our priority.
  • Training and career development, with onboarding programs for new employees and tuition assistance.
  • Financial security through competitive compensation, incentives, and retirement plans.

Estimated Salary: $97,300-$135,000 per year



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