MES Specialist

The MES Change Specialist supports a highly automated pharmaceutical production and packaging facility by designing, building, testing, validating, and maintaining manufacturing execution system (MES) recipes and electronic documentation. This onsite role in Hillsboro, OR operates within the Process and Compliance team, working cross-functionally with manufacturing, process control, IT/OT, master data, and other departments to ensure efficient construction and reliable functionality of electronic batch records and workflows across the site.

• Troubleshoot and resolve mechanical and automation-related failures in production to maintain reliable operations.
• Analyze system performance data to identify opportunities for process improvement, cost reduction, and increased efficiency.
• Lead the gathering of user requirements for operational needs and perform initial assessments for MES modifications.
• Own computer system validation (CSV) activities, including defining requirements and authoring and executing test scripts.
• Translate operational requirements into MES recipe and workflow specifications that define CSV test protocols.
• Develop, author, and execute protocols for configuration verification (CV) and functional verification (FV) testing of MES recipes and workflows in accordance with approved procedures and CSV principles.
• Investigate and assess exceptions and deviations arising from CV and FV protocol testing, and support resolution activities.
• Plan, execute, review, and continuously improve MES changes for assigned manufacturing processes as part of the formal change management process, including testing and implementation.
• Monitor project schedules for MES-related activities and elevate concerns to leadership in time to enable effective mitigation.
• Assist in drafting comprehensive test plans and reports for MES changes, including new and updated recipes.
• Own MES-related deviations, including high-complexity or multi-site deviations linked to MES defects, and ensure corrective actions effectively resolve underlying issues.
• Support MES components of broader site initiatives, including capital projects, technology transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new product launches.
• Serve as audit support for MES by providing demonstrations, presentations, and responses to auditor questions, and contribute to the closure of MES-related regulatory findings.
• Maintain accurate document control and quality assurance practices related to MES configurations, changes, and test documentation.
• Coordinate action items and approvals across multiple departments within electronic change management systems to drive changes from initiation through closure.

• Bachelors degree in a relevant field with 35 years of MES, electronic batch record, or computerized systems experience in regulated manufacturing, or a Masters degree in a relevant field.
• Demonstrated experience in the construction, testing, and validation of computerized systems in a regulated environment.
• Extensive experience using electronic change management systems such as Track Wise, Veeva, or similar platforms to own changes and coordinate cross-functional activities.
• Prior experience in IT, OT, software technical writing, quality systems, and validation (CSV/CSA, GAMP) within a regulated industry.
• Strong understanding of test requirements for electronic data systems to meet regulatory compliance expectations.
• Knowledge of automation systems including SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC), and Human Machine Interfaces (HMI).
• Hands-on experience with sterile pharmaceutical manufacturing processes such as solution preparation, equipment preparation, liquid and lyophilized vial filling, pre-filled syringe (PFS) formulation, inspection, and packaging.
• Proven ownership of changes in electronic change management systems (for example, Veeva) from initiation through closure.
• Experience troubleshooting Rockwell automation systems, with remote or onsite support strongly preferred.
• Ability to author and execute CSV protocols, including CV and FV testing, and to manage related deviations and corrective actions.
• Strong document control and quality assurance skills related to MES and computerized systems.
• Ability to work effectively in cross-functional teams and communicate clearly with manufacturing, IT/OT, quality, and other stakeholders.