MES Change & Validation Specialist

Motion Recruitment; Hillsboro (OR); On-site; USD 90,000 - 110,000; Full time

Job summary

Motion Recruitment seeks an MES Change Specialist to join the Process and Compliance Team in Hillsboro, OR. The role spans designing, testing, validating, and maintaining electronic documentation for operations across the site.

You will work cross-functionally to ensure compliant MES changes, develop test plans, and support regulatory readiness while leveraging data analytics to optimize performance.

Qualifications

• As part of a regulated manufacturing setting, a degree plus 3–5 years of MES or electronic batch record experience is required.
• Experience constructing, testing, and validating computerized systems is essential.
• Familiarity with change management systems (TrackWise, Veeva) to coordinate multi-department actions.
• General knowledge of CSV/CSA/validation concepts and GAMP is preferred.

Responsibilities

• Troubleshoot mechanical or automation-related production issues.
• Apply data analytics to improve efficiency and reduce costs.
• Lead user requirements for MES modifications and assess initial requirements.
• Own CSV functions including test script definition and execution.
• Translate requirements into MES recipe/workflow specifications and test protocols.
• Develop and execute CV/FV testing for MES recipes and workflows.
• Review and manage MES changes via change control processes.
• Monitor project schedule and escalate risks to leadership.
• Draft test plans for MES changes and assess deviations.
• Support MES components of capital projects, tech transfers, and regulatory findings.

Skills

MES experience

Data analytics

CSV testing

Regulatory compliance

Change management

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

TrackWise

Veeva

SAP

HMI

PLC

Job description

Motion Recruitment seeks an MES Change Specialist to join the Process and Compliance Team in Hillsboro, OR. The role spans designing, testing, validating, and maintaining electronic documentation for operations across the site.

You will work cross-functionally to ensure compliant MES changes, develop test plans, and support regulatory readiness while leveraging data analytics to optimize performance.