Manufacturing System Analyst

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.

• 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.

• 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 Track Wise.
• 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.

Rockwell systems troubleshooting experience.

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

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