The Associate Product Validation Specialist prepares equipment configurations and instrument interfaces, executes quality control testing and validation test cases from the user’s workflow perspective and meticulously documents validation test results. They may be involved in the planning of validation testing, developing test protocols, and identifying and investigating product performance issues.
Principal Contributions / Accountabilities & Associated Activities:
- Prepares equipment configurations and interfaces
- Executes product validation test runs and produces object evidence to support testing
- Reports equipment, procedures, and product testing results
- Identifies testing problems and product issues and reports them to Validation project leads
- Executes quality control testing, documents results and generates reports
- Participates in the analysis of testing issues and product anomalies
- Ensures products meet company requirements
- Writes concise problem statements which describe the issue, resolution, and impact to validation
- Provides input into the validation strategy and testing plans along with other members of the validation team
- Seeks information about the company’s products and their uses
- Prepares for the defense of validations for design reviews, internal audits and assists with preparation for external audits
Experience, Skills & Qualifications:
- Bachelors of Science degree (Preferably in Clinical Laboratory Science, Biology, Health Science, or Microbiology)
- Minimum 2 years of experience performing testing and or validation in a laboratory setting with BIOMERIEUX or competitor products
- Demonstrated communication skills, both verbal and written
- Experience with VITEK 2, VITEK 2 Compact, VITEK MS, OBSERVA, MYLA, VIRTUO and/or BACT/ALERT preferred
- Experience with setup/maintenance/troubleshooting of computer interfaces is desired
