Pharma MES & CSV Systems Analyst

Motion Recruitment; Hillsboro (OR); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Motion Recruitment seeks a highly skilled MES/CSV professional to strengthen the digital systems behind pharmaceutical manufacturing. You will collaborate 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.

You will lead change reviews, own CSV activities, and ensure regulatory compliance while supporting new recipes, tech transfers, and product

Qualifikationen

• Bachelor's degree in a relevant field and 3–5 years MES/electronic batch record or computerized systems experience in regulated manufacturing.
• 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.

Aufgaben

• 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.

Kenntnisse

MES experience

electronic batch record

computerized systems

CSV/CSA

GAMP

regulatory compliance

SAP

PLCs

HMIs

validation

Ausbildung

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

Veeva

TrackWise

Rockwell

SAP

Jobbeschreibung

Motion Recruitment seeks a highly skilled MES/CSV professional to strengthen the digital systems behind pharmaceutical manufacturing. You will collaborate 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.

You will lead change reviews, own CSV activities, and ensure regulatory compliance while supporting new recipes, tech transfers, and product