Manufacturing System Analyst

MES Change Specialist

📍 Onsite in Hillsboro, Oregon

Help strengthen the digital systems behind pharmaceutical manufacturing. In this role, you’ll partner with Manufacturing, Process & Compliance, IT/OT, Master Data, and other teams to build, test, validate, and maintain MES recipes and workflows in a highly automated production and packaging environment.

What you’ll do

• Gather operational requirements and translate them into MES recipe and workflow requirements.
• Lead change reviews for assigned manufacturing processes, from testing through implementation.
• Own Computerized System Validation (CSV) activities, including requirements, test scripts, and CV/FV protocol execution.
• Investigate test exceptions, MES defects, and deviations; drive effective corrective actions.
• Support new recipes, tech transfers, capital projects, shutdowns, and product launches.
• Track schedules, raise risks early, and support MES audit demonstrations and regulatory follow-up.
• Identify opportunities to improve system performance, efficiency, and cost.

What we’re looking for

• A bachelor’s degree in a relevant field plus 3–5 years of MES, electronic batch record, or computerized systems experience in regulated manufacturing—or a master’s degree in a relevant field.
• Experience building, testing, and validating computerized systems.
• Hands-on change ownership in systems such as Veeva or TrackWise.
• Knowledge of CSV/CSA, GAMP, quality systems, and electronic-data compliance requirements.
• Familiarity with MES, SAP, PLCs, and HMIs.
• Experience in sterile pharmaceutical manufacturing, such as formulation, vial filling, PFS, inspection, or packaging.

Strongly preferred: Rockwell systems troubleshooting experience.

A plus: EBR or MES deployment experience.

If you enjoy solving complex manufacturing challenges and making compliant digital processes work better, let’s connect.

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