MES Change Specialist

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Manufacturing organization at HTO is divided into two groups, Aseptic Operations and Finished Goods, which combine to produce millions of units of life-saving medicine every year to patients around the world.

Please note there are multiple positions available across both Aseptic Operations and Finished Goods Manufacturing

The Opportunity:

As a key member of the Process and Compliance team, 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.

• 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
• 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 escalate 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.

• You hold a Bachelor’s degree in a relevant field plus 3-5 years of MES, electronic batch record, or computerized systems experience for regulated manufacturing OR Master’s 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
• 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