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MES Specialist
Job in
Hillsboro, Washington County, Oregon, 97104, USA
Listed on 2026-10-16
Listing for:
eTeam
Full Time
position Listed on 2026-10-16
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
- 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.
- 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.
- Bachelor's degree in a relevant field with 3-5 years of MES, E , 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 Track Wise.
- 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.
- Experience in sterile pharmaceutical manufacturing, including formulation, filling, inspection, or packaging.
- Experience with MES or E 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.
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