MES Change Specialist

Hillsboro Technical Operations (HTO) is a drug product and finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio and pipeline products. The manufacturing organization at HTO is divided into two groups: Aseptic Operations and Finished Goods, which together produce millions of units of life‑saving medicine every year. Multiple positions are available across both groups. The Opportunity As a key member of the Process and Compliance team, the MES Change Specialist will design, build, test, validate, and maintain pharmaceutical production in a state‑of‑the‑art, highly‑automated facility. The role works cross‑functionally with manufacturing, P&C, ITOT, Master data, and many other departments to ensure the efficient construction and effective functionality of electronic documentation across HTO. Responsibilities Troubleshoot and identify resolutions for mechanical or automation failures in production. Identify opportunities to improve using data analytics of system performance to reduce costs and increase efficiency. Lead user requirement gathering for operational needs and perform initial requirement assessments for MES modifications. Own CSV functions – define requirements, write and execute test scripts. Plan, execute, and review MES changes for assigned manufacturing processes through the change management process, including testing and implementation. Monitor project schedules and elevate concerns to leadership to mitigate risks. Assist with drafting test plans for MES changes, including comprehensive plans and reports for new recipes. Own MES‑related deviations, including high‑complexity or multi‑site deviations, and ensure corrective actions resolve issues effectively. Support MES components of other site initiatives: capitalized projects, tech transfers, DS/DP changes, shutdown projects, and new launches. Serve as audit support for MES, providing demonstrations, presentations, and answering questions; support closure of any MES‑related regulatory findings when applicable. Qualifications Bachelor’s degree in a relevant field with 3–5 years of MES, electronic batch record, or computerized systems experience in regulated manufacturing, or Master’s degree in a relevant field. Prior experience with construction, testing, and validation of computerized systems. Extensive experience working with electronic change management systems (e.g., TrackWise, Veeva) to own changes and coordinate action items across multiple departments. Strong understanding of test requirements for electronic data systems for regulatory compliance. Knowledge of automation systems including SAP, MES, PLC, and HMI. 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 (e.g., Veeva) from initiation to closure. Experience troubleshooting Rockwell systems (remote or on‑site) strongly preferred. Preferred: prior experience on an EBR or MES deployment project. Salary & Benefits Location: Hillsboro, OR Salary Range: $79,000 – $146,000 (based on experience, level, qualifications, geography, and other lawful factors). Additional compensation may include a discretionary annual bonus based on individual and company performance. This position is eligible for relocation benefits. For full benefits information, refer to the company benefits package. EEO Statement Genentech is an equal‑opportunity employer. The company’s policy prohibits unlawful discrimination, including discrimination on the basis of protected veteran status, disability status, and is consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr F. Hoffmann-La Roche AG