MES Change Lead — CSV & Validation Testing

Tranzeal Incorporated; Hillsboro (OR); On-site; USD 90,000 - 130,000; Full time

Job summary

Tranzeal Incorporated is seeking an MES Change Specialist to support design, build, test, validate, and maintain pharmaceutical production in a state-of-the-art facility. You will work across manufacturing, P&C, ITOT, and other departments to ensure accurate electronic documentation for operations in HTO.

You will lead requirements gathering for MES modifications, own CSV testing, and oversee CV/FV testing of MES recipes and workflows, including deviation handling and audit support to close

Qualifications

• Troubleshoot mechanical or automation failures in production.
• Identify opportunities to improve efficiency through data analytics.
• Lead user requirement gathering for operational needs and MES changes.
• Own CSV functions: defining requirements, writing and executing test scripts.

Responsibilities

• Develop, author, and execute CV/FV testing protocols for MES recipes and workflows.
• Investigate and assess exceptions and deviations from CV and FV testing.
• Plan, execute, and improve review of MES changes across manufacturing processes.
• Monitor project schedule and escalate concerns to leadership with mitigation plans.
• Draft test plans for MES changes and provide comprehensive test reports.
• Manage MES-related deviations and drive corrective actions across sites.

Skills

Troubleshooting

Automation

Data analytics

Requirements gathering

CSV testing

CV/FV testing

Change management

Test planning

Deviations management

Audit support

Job description

Tranzeal Incorporated is seeking an MES Change Specialist to support design, build, test, validate, and maintain pharmaceutical production in a state-of-the-art facility. You will work across manufacturing, P&C, ITOT, and other departments to ensure accurate electronic documentation for operations in HTO.

You will lead requirements gathering for MES modifications, own CSV testing, and oversee CV/FV testing of MES recipes and workflows, including deviation handling and audit support to close