Pharma MES Change Lead — Validation & CSV Expert

Russell Tobin; Hillsboro (OR); On-site; USD 65,000 - 71,000; Full time

Job summary

Russell Tobin is partnering with a top pharmaceuticals and diagnostics company in Hillsboro, OR to identify an MES Change Specialist. The role focuses on troubleshooting MES, CSV, CV, FV testing, and change management across manufacturing processes.

Requirements include a bachelor's (or master’s) in a relevant field with 3–5 years’ MES or electronic batch record experience, trackwise/Veeva exposure, and strong regulatory knowledge. On-site position with extended duration and competitive pay.

Qualifications

• Bachelor's degree in a relevant field with 3–5 years MES, electronic batch record, or computerized systems experience; or a Master's degree in a relevant field.
• Experience with construction, testing, and validation of computerized systems.
• Experience with electronic change management systems (Trackwise, Veeva) to own changes and coordinate actions across departments.
• IT/OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP) in regulated environments.
• Understanding test requirements for electronic data systems for regulatory compliance.
• Knowledge of SAP, MES, PLCs, and HMI in automation environments.

Responsibilities

• Troubleshoot and identify resolutions for mechanical or automation failures in production.
• Lead data analytics to improve performance, reduce costs, and increase efficiency.
• Own changes in MES, from initiation to closure, across multiple processes.
• Develop, author, and execute protocols for CV and FV testing of MES recipes and workflows.
• Draft test plans and reports for MES changes, including new recipes and regression testing.

Skills

MES

Electronic Batch Record

Computerized systems

IT/OT knowledge

Regulatory compliance

Education

Bachelor's degree in relevant field

Master's degree in relevant field

Tools

Trackwise

Veeva

Job description

Russell Tobin is partnering with a top pharmaceuticals and diagnostics company in Hillsboro, OR to identify an MES Change Specialist. The role focuses on troubleshooting MES, CSV, CV, FV testing, and change management across manufacturing processes.

Requirements include a bachelor's (or master’s) in a relevant field with 3–5 years’ MES or electronic batch record experience, trackwise/Veeva exposure, and strong regulatory knowledge. On-site position with extended duration and competitive pay.