Validation Engineer

Your Job

Phillips-Medisize, a Molex Company is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries.

Our Global Technical Services Team is seeking a Validation Engineer to support operations in our Hudson, WI site and other Wisconsin locations.

This role will support manufacturing in the effort to ensure optimum validation of projects/programs to meet customer, regulatory and manufacturing requirements.

This is a hybrid position that can be based out of Hudson, New Richmond, or Menomonie depending on where the individual resides.

Our Team

Phillips-Medisize is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries.

Our team at Hudson, WI is made up roughly of 300 employees that support our production, Engineering, Quality, Molding & Tooling departments.

What You Will Do



* Coordinate and lead validation projects and discussions.


* Work with project teams to define the validation strategy.


* Draft MVPs, equipment qualification, protocol/test case, deviations and summary report documentation for project wrap up.


* Execute computer system/software validation activities including risk assessments and part 11 compliance requirements


* Interface with customers to resolve issues and harmonize validation requirements.


* Learn and deploy SAP related tools and deliverables associated with validation documents and document approval workflows.


* Provide statistical analysis support to sites and validation teams.


* Assist with creating, updating, and training on WI, SOP, and other necessary documents needed to perform validation work.


* Support global rollout of Global Validation requirements and on-site or desk audits of Phillips-Medisize sites to ensure compliance to the global standards.


* Share validation best practices information and suggest improvement opportunities


* Travel to other Wisconsin Phillips Medisize sites (up to 50%) with occasional travel outside Wisconsin as needed.

Who You Are (Basic Qualifications)



* Bachelor's Degree in a scientific discipline or 4 + years of direct Quality experience


* 1+ years experience working in a regulated manufacturing environment; medical manufacturing preferred

What Will Put You Ahead



* Strong organizational, and problem-solving skills and an understanding of quality system requirements


* Ability to identify problems, and develop and implement actions to resolve them


* Experience working with Microsoft Outlook, Word, Excel, and PowerPoint


* Project management experience


* Leadership/mentorship experience


* Working knowledge of medical device assembly and inspection equipment

This position does not qualify for VISA Sponsorship.

In order to comply with U.S.

export control laws and regulations, this position requires applicants t...