MES Change Specialist

MES Change Specialist

Location: Hillsboro, OR

Work Arrangement: Onsite

Job Summary

• Support MES change management, system testing, validation, and electronic batch records in a highly automated pharmaceutical manufacturing facility.
• Ensure manufacturing workflows meet operational requirements and regulatory compliance standards.

Key Responsibilities

• Manage MES changes from initiation through testing, implementation, and closure.
• Gather requirements from manufacturing, IT/OT, Quality, and cross-functional teams.
• Develop and execute test scripts, test plans, and validation protocols.
• Perform Configuration Verification (CV) and Functional Verification (FV) testing.
• Investigate system defects, testing exceptions, and deviations; implement corrective actions.
• Support electronic batch records, MES recipes, and manufacturing workflow modifications.
• Ensure compliance with CSV/CSA principles, GAMP, and regulatory requirements.
• Monitor project timelines, identify risks, and escalate issues to leadership.
• Support technology transfers, capital projects, shutdowns, and new product launches.
• Assist with audits, regulatory inspections, and MES-related findings.
• Identify opportunities to improve manufacturing efficiency and system performance.

Required Qualifications

• Bachelor's degree in a relevant field with 3–5 years of MES, EBR, or computerized systems experience in regulated manufacturing, or a relevant master's degree.
• Experience in computerized systems testing and validation.
• Experience with change management systems such as Veeva or TrackWise.
• Knowledge of CSV/CSA, GAMP, quality systems, and regulatory compliance.
• Experience writing and executing test scripts and validation protocols.
• Understanding of MES, SAP, PLC, and HMI systems.
• Experience in pharmaceutical, biotechnology, or other regulated manufacturing environments.

Preferred Qualifications

• Experience in sterile pharmaceutical manufacturing, including formulation, filling, inspection, or packaging.
• Experience with MES or EBR implementation projects.
• Familiarity with Rockwell Automation systems and troubleshooting.
• Experience managing deviations, CAPA, and cross-functional change controls.
• Strong documentation, communication, and problem-solving skills.

Key Skills

MES | EBR | CSV/CSA | GAMP | Change Control | Veeva | TrackWise | GMP/cGMP | Validation Testing | SAP | PLC/HMI | Rockwell Automation