MES Change Specialist

TalentBurst•Hillsboro, OR

8d•Onsite

About The Position

The MES Change Specialist is part of the Process and Compliance Team in a highly automated pharmaceutical manufacturing and packaging facility. The role supports the design, construction, testing, validation, and maintenance of production systems and electronic documentation. Working cross-functionally with manufacturing, P&C, ITOT, Master Data, and other departments, the specialist ensures electronic documentation functions effectively for operations across HTO. The specialist owns CSV activities and MES change reviews for assigned manufacturing processes, including requirements gathering, recipe and workflow development, test protocol preparation and execution, exception investigation, and implementation. The role also supports deviations, site initiatives, audits, regulatory finding closure, and continuous improvement of system performance. The position is onsite in Hillsboro, Oregon, for a stated duration of 07+ months.

Requirements

Bachelor's degree in a relevant field plus 3–5 years of MES, electronic batch record, or computerized systems experience in regulated manufacturing, or a master's degree in a relevant field.
Prior experience constructing, testing, and validating computerized systems.
Extensive experience using electronic change management systems such as TrackWise or Veeva to own changes and coordinate action items across multiple departments.
Prior experience in IT, OT, or software technical writing, quality systems, and validation (CSV/CSA, GAMP), preferably in a regulated industry.
Strong understanding of test requirements for electronic data systems in support of regulatory compliance.
Knowledge of automation systems including SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC), and Human Machine Interfaces (HMI).
Prior experience with sterile pharmaceutical manufacturing, such as solution preparation, equipment preparation, liquid or lyophilized vial filling, PFS, formulation, inspection, or packaging.
Experience owning changes in a change management system, such as Veeva, from initiation through closure.

Nice To Haves

Experience troubleshooting Rockwell systems, including remote or onsite support.
Prior experience on an EBR or MES deployment project.

Responsibilities

Troubleshoot mechanical or automation-related production failures and identify resolutions.
Use system performance data analytics to identify opportunities to reduce costs and improve efficiency.
Lead user-requirement gathering for operational needs and perform initial assessments of MES modifications.
Own computerized system validation (CSV) functions, including defining requirements and writing and executing test scripts.
Translate operational requirements into recipe and workflow requirements that define CSV test protocols.
Develop, author, and execute configuration verification (CV) and functional verification (FV) protocols for MES recipes and workflows according to approved procedures and CSV principles.
Investigate and assess exceptions and deviations from CV and FV protocol testing.
Plan, execute, and improve reviews of MES changes for assigned manufacturing processes, including testing and implementation through the change management process.
Monitor project schedules and escalate concerns to leadership early enough to allow mitigation.
Assist with drafting MES change test plans, including comprehensive test plans and reports for new recipes.
Own MES-related deviations, including high-complexity or multi-site deviations relating to MES defects, and ensure corrective actions resolve issues effectively.
Support MES components of site initiatives, including capital projects, tech transfers, Drug Substance/Drug Product changes, shutdown projects, and new launches.
Provide MES audit support through demonstrations, presentations, and responses to questions; support closure of MES-related regulatory findings when relevant.