What are the responsibilities and job description for the Validation Engineer III position at TekOne IT Services Pvt. Ltd.?
Role: Validation Engineer III
Location: Plymouth, MN - 55442
Duration: 06 Months
Summary
Location: Plymouth, MN - 55442
Duration: 06 Months
Summary
- We are seeking a Method Validation Engineer with 2-5 years of experience in R&D or quality roles to support a project focused on validating test methods used in receiving inspection and production. The individual will develop and execute test method validation protocols, ensuring alignment with industry standards and regulatory requirements.
- Document existing test methods used in manufacturing processes.
- Write and execute test method validation protocols with clear documentation and appropriate data analysis.
- Ensure compliance by routing documentation within the company's quality management system.
- Review existing quality system documentation and evaluate against current industry standards.
- Bachelor's degree in an Engineering discipline or other technical field.
- Preferred: BS in Mechanical Engineering (ME) or Biomedical Engineering (BME) or other science-based fields.
- Minimum 2-5 years in a related R&D or Quality role.
- Expertise in test method development, including familiarity with industry standards.
- Experience with test method validation, inspection method validation, and gage R&R.
- Strong background in protocol development and report writing.
- Ability to coordinate testing activities and manage documentation.
- Exceptional attention to detail.
- Competent in data analysis and application of statistical techniques.
- Ability to document findings and communicate deviations clearly, with justification.