Phillips-Medisize is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries. Our Hudson, Wisconsin location is seeking a Validation Engineer to provide global support for Phillips-Medisize medical device manufacturing operations. In this role, you’ll provide direction to and leadership on process validation activities for all aspects of our medical product manufacturing operations. You will work directly with other Quality and automation personnel to drive the validation compliance needs of Phillips-Medisize and the customer. If you’re solution-based, committed to value creation and dedicated to quality, this could be the opportunity for you!
What You Will Do In Your Role
- Coordinate and lead commissioning, qualification, and validation activities for manual and automated manufacturing equipment and computerized systems
- Prepare compliant and efficient validation plans, protocols, test cases, and summary reports
- Assist with the execution of validation protocols
- Interface with internal and external customers on all matters related to quality and process validation
- Drive continuous improvement via Key Performance Indicators (KPIs)
- Serve as a subject matter expert to provide support during customer and regulatory inspections, reviews, and on-site meetings
The Experience You Will Bring
- Bachelor’s Degree
- Experience within a medical Quality organization
- Highly competent with Microsoft Office (Word/Excel/Outlook/PowerPoint)
What Will Put You Ahead
- 2+ years of hands-on process validation experience
- Experience with IQ/OQ/PQ in medical device manufacturing
- Experience in creating SOP’s & instructions
- Experience with SAP
Salary and Benefits Commensurate with Experience.
Equal Opportunity Employer.
Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test.
This employer uses E-Verify. Please visit the following website for additional information: www.kochcareers.com/doc/Everify.pdf
This role is not eligible for VISA sponsorship