MES Change Specialist

eTeam; Hillsboro (OR); On-site; USD 95,000 - 135,000; Full time

Job summary

eTeam in Hillsboro, Oregon seeks a MES/EBR engineer to lead change management, testing, validation, and electronic batch records in a highly automated pharma facility. You will manage MES changes from initiation through testing and closure, gather requirements from manufacturing, IT/OT, Quality, and cross‑functional teams, and develop test scripts and validation protocols.

A Bachelor's degree with 3–5 years of MES/EBR experience in regulated manufacturing is required.

Qualifications

• Bachelor's degree with 3-5 years in MES/EBR in regulated manufacturing
• Experience in computerized systems testing and validation
• Familiarity with CSV/CSA, GAMP, and quality systems/regulatory compliance
• Experience writing/executing test scripts and validation protocols
• Understanding of MES, SAP, PLC, and HMI systems

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 CV and FV testing
• Investigate defects, testing exceptions, and deviations; implement corrective actions
• Support electronic batch records, MES recipes, and workflow modifications
• Ensure compliance with CSV/CSA, GAMP, and regulatory requirements
• Monitor project timelines, identify risks, and escalate issues
• Support tech transfers, capital projects, shutdowns, and new product launches
• Assist with audits and regulatory inspections and MES findings
• Identify opportunities to improve manufacturing efficiency and system performance

Skills

MES & EBR systems

Test planning & execution

Regulatory compliance

Cross-functional collaboration

Documentation & reporting

Education

Bachelor's degree in a relevant field

Master's degree (preferred)

Tools

Veeva

TrackWise

GAMP

Job description

• 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 escalates 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.