MES Change Specialist

Motion Recruitment; Hillsboro (OR); On-site; USD 90,000 - 110,000; Full time

Job summary

Motion Recruitment seeks an MES Change Specialist to join the Process and Compliance Team in Hillsboro, OR. The role spans designing, testing, validating, and maintaining electronic documentation for operations across the site.

You will work cross-functionally to ensure compliant MES changes, develop test plans, and support regulatory readiness while leveraging data analytics to optimize performance.

Qualifications

• As part of a regulated manufacturing setting, a degree plus 3–5 years of MES or electronic batch record experience is required.
• Experience constructing, testing, and validating computerized systems is essential.
• Familiarity with change management systems (TrackWise, Veeva) to coordinate multi-department actions.
• General knowledge of CSV/CSA/validation concepts and GAMP is preferred.

Responsibilities

• Troubleshoot mechanical or automation-related production issues.
• Apply data analytics to improve efficiency and reduce costs.
• Lead user requirements for MES modifications and assess initial requirements.
• Own CSV functions including test script definition and execution.
• Translate requirements into MES recipe/workflow specifications and test protocols.
• Develop and execute CV/FV testing for MES recipes and workflows.
• Review and manage MES changes via change control processes.
• Monitor project schedule and escalate risks to leadership.
• Draft test plans for MES changes and assess deviations.
• Support MES components of capital projects, tech transfers, and regulatory findings.

Skills

MES experience

Data analytics

CSV testing

Regulatory compliance

Change management

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Tools

TrackWise

Veeva

SAP

HMI

PLC

Job description

Title:

MES Change Specialist

Work Location :

Hillsboro, OR, 97124.

Contract Duration :

8 months with Possible extension

Summary:

As part of the Process and Compliance Team in manufacturing, you will perform a wide variety of tasks and operations that are required to design, build, test, validate, and maintain pharmaceutical production in a state-of-the-art, highly-automated production and packaging facility. The MES Change Specialist works cross-functionally with manufacturing, P&C, ITOT, Master data, and many other departments to ensure the efficient construction and effective functionality of our electronic documentation for operations across HTO.

Responsibilities:

• You will troubleshoot and identify resolutions for mechanical or automation related failures in production
• You will identify opportunities to improve leveraging data analytics of system performance to deliver reduced costs and increased efficiency.
• You will lead user requirement gathering for operational needs and perform initial requirement assessments for MES modifications
• You will own CSV functions including defining requirements, writing and execution of test scripts
• Translate operational requirements into recipe and workflow requirements that will define CSV test protocols
• Development, authoring, and executing of protocols for configuration verification (CV) and functional verification (FV) testing of MES recipes and workflows according to approved procedures and CSV principles
• Investigate and assess exceptions and deviations from CV and FV protocol testing
• You will own plan, execute, and improve review of MES changes for a set of assigned manufacturing processes driven by the change management process, including testing and implementation
• You will monitor project schedule and escalator concerns to leadership with appropriate time to mitigate
• You will assist with drafting test plans for MES changes, including comprehensive test plans and/or reports for new recipes
• You will own MES-related deviations, including high-complexity or multi-site deviations relating to MES defects. Ensure corrective actions resolve issues effectively
• You will support MES-components of other site initiatives, including capitalized projects, tech transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new launches
• You will serve as an audit support for MES, providing demonstrations, presentations, and answering questions as required. If topical, support closure of any MES-related regulatory findings.

Who you are:

• You hold a Bachelors degree in a relevant field plus 3-5 years of MES, electronic batch record, or computerized systems experience for regulated manufacturing OR Masters degree in a relevant field
• You have prior experience with construction, testing, and validation of computerized systems
• You have extensive prior experience working in electronic change management systems (trackwise, Veeva, etc.) to own changes and coordinate action items spanning multiple departments
• Prior experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry.
• You have a strong understanding of test requirements for electronic data systems for regulatory compliance
• You have knowledge of the automation systems that include SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC) and Human Machine Interfaces (HMI)
• You have prior experience with sterile pharmaceutical manufacturing (solution prep, equipment prep, liquid/lyo vial filling, PFS, formulation, inspection, packaging, etc)
• Ownership of changes in a change management system (ex. Veeva) from initiation to closure
• You have experience with troubleshooting Rockwell systems, including remote or on-site support, is strongly preferred
• It is preferred you have prior experience on an EBR or MES deployment projects.