Pharma MES Change Specialist - Validation & CSV Expert

Planet Pharma; Hillsboro (OR); On-site; USD 76,000 - 94,000; Full time

Job summary

Planet Pharma is seeking an MES Change Specialist to design, test, validate, and maintain electronic documentation for operations in a state-of-the-art pharmaceutical facility. You will own MES changes across multiple departments, perform CV/FV testing, and drive change management to ensure compliant, efficient production processes.

The role requires a Bachelor’s or Master’s degree in a relevant field with 3–5 years of MES/EBR experience, familiarity with TrackWise and Veeva, and strong

Qualifications

• Bachelor's or Master's in a relevant field with 3–5 years MES/electronic batch record experience.
• Experience constructing, testing, and validating computerized systems.
• Extensive experience with electronic change management systems (e.g., TrackWise, Veeva).
• Knowledge of SAP, MES, PLCs, and HMI in regulated environments.

Responsibilities

• Troubleshoot mechanical/automation failures in production.
• Identify opportunities to improve using data analytics for efficiency.
• Lead requirements gathering and assess MES modifications.
• Own CSV requirements, test scripts, and execution.
• Translate requirements into recipe/workflow specs for CSV testing.
• Develop, author, and execute CV/FV testing protocols for MES.
• Investigate deviations from CV/FV testing.
• Plan, execute, and review MES changes per Change Management process.
• Monitor project schedules and escalate as needed.
• Draft test plans for MES changes.
• Own MES-related deviations and ensure corrective actions.
• Support MES components of site initiatives (capital projects, tech transfers, DS/DP changes).
• Provide audit support for MES and assist with regulatory findings closure.

Skills

Troubleshooting

Data analytics

Requirements gathering

CSV testing

CV testing

FV testing

Change management

Deviations handling

Project management

Test planning

MES issue resolution

Cross-functional collaboration

Audit support

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

TrackWise

Veeva

Rockwell

Job description

Planet Pharma is seeking an MES Change Specialist to design, test, validate, and maintain electronic documentation for operations in a state-of-the-art pharmaceutical facility. You will own MES changes across multiple departments, perform CV/FV testing, and drive change management to ensure compliant, efficient production processes.

The role requires a Bachelor’s or Master’s degree in a relevant field with 3–5 years of MES/EBR experience, familiarity with TrackWise and Veeva, and strong