MES Change Specialist: CSV & Test Protocol Leader

Pride Global; Hillsboro (OR); On-site; USD 90,000 - 96,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) retirement savings

Life & disability insurance

Employee discounts

Equal opportunity employer

Job summary

Pride Global is seeking an experienced MES/CSV professional for an onsite Hillsboro, OR contract role. You will troubleshoot automation in production, drive MES changes, and own CSV test protocols across multiple departments.

Responsibilities include validating CV/FV for MES recipes, coordinating change management, and supporting site initiatives. Prior experience with regulatory compliance and IT/OT is highly valued. This is an 8+ month assignment with competitive hourly pay.

Qualifications

• Bachelor's degree plus 3–5 years MES/electronic batch record experience or a Master's degree
• Experience with construction, testing, and validation of computerized systems
• Extensive experience with electronic change management systems (Trackwise, Veeva, etc.) to own changes across departments
• Experience in IT/OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP)
• Strong understanding of test requirements for electronic data systems for regulatory compliance

Responsibilities

• Troubleshoot and resolve mechanical or automation failures in production
• Lead requirements gathering for MES modifications and assess initial requirements
• Own CSV functions including writing and executing test scripts
• Translate operational requirements into recipe/workflow requirements for CSV test protocols
• Develop, author, and execute CV and FV testing of MES recipes/workflows
• Investigate deviations from CV/FV protocols and assess exceptions
• Plan, execute, and improve review of MES changes across manufacturing processes
• Monitor project schedule and escalate concerns to leadership
• Draft test plans for MES changes and prepare comprehensive test reports
• Own MES-related deviations and ensure effective corrective actions
• Support MES components of site initiatives and capitalized projects
• Provide audit support for MES with demonstrations and regulatory responses

Skills

MES knowledge

CSV testing

Data analysis

Trackwise

Veeva

Rockwell troubleshooting

Regulatory manufacturing

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

SAP

MES

PLC

HMI

Job description

Pride Global is seeking an experienced MES/CSV professional for an onsite Hillsboro, OR contract role. You will troubleshoot automation in production, drive MES changes, and own CSV test protocols across multiple departments.

Responsibilities include validating CV/FV for MES recipes, coordinating change management, and supporting site initiatives. Prior experience with regulatory compliance and IT/OT is highly valued. This is an 8+ month assignment with competitive hourly pay.