Validation Engineer (Test Method Validation) – Medical Device Insdustry
Start Date: October 11th
Duration: 9 months initial duration with potential for work through 2023.
Our client in Bloomington, IN is looking for a Test Method Validation Engineer that can work a hybrid role 50% on site with full expenses covered and 50% remote.
Project Details:
Our medical device client on the east coast is in need of a Test Method Validation Subject Matter Expert to help with a legacy prodcut remediation program.
Primary responsibilities include:
- Review legacy products and apply accurate TMV standards
- Establish standard best practices
- A background in metrology is a bonus
- Training / mentoring junior leve engineers
Additional responsibilities may include:
- Run process qualifications including Instillation Qualification, Operational Qualification and Performance / IQ OQ PQ.
- Develop, design and execute validation protocols
- Review and approve engineering change control, plant validation protocols and reports
- Establish, coordinate and act as subject matter expert for the site’s Master Validation Plan, schedule, execution of schedule, validation police and practice
- Write, review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures, standard calibration methods, standard test methods, specifications CAPAs and exception reports.
- Lead Engineering team in the qualification of new equipment for inspection, including development and validation of routines for automation of complex visual inspection systems.
- Perform training to procedural and quality system changes.
- Facilitate Risk Management process in compliance to appropriate external standards and corporate policies.
- Drive Quality Engineering activities designed to improve customer satisfaction and achievement of company quality objectives.
- Has advanced knowledge in the areas of Quality Assurance, Process Validation, Design Controls, Risk Management and Statistical Techniques.
- Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures.
***FOR IMMEDIATE CONSIDERATION, please submit your contact information and resume.
Qualified candidates will be contacted immediatley. No 3rd party vendors please.
Thank you for your interest in Treximo!