MES Change Specialist

Genentech•Hillsboro, OR

1d•Onsite

About The Position

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 that there are multiple positions available across both Aseptic Operations and Finished Goods Manufacturing. 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.

Requirements

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
Prior experience with construction, testing, and validation of computerized systems
Extensive prior experience working in electronic change management systems (trackwise, Veeva, etc.) to own changes and coordinate action items spanning multiple departments
Strong understanding of test requirements for electronic data systems for regulatory compliance
Knowledge of the automation systems that include SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC) and Human Machine Interfaces (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 (ex. Veeva) from initiation to closure

Nice To Haves

Experience with troubleshooting Rockwell systems, including remote or on-site support, is strongly preferred
Prior experience on an EBR or MES deployment projects

Responsibilities

Troubleshoot and identify resolutions for mechanical or automation related failures in production
Identify opportunities to improve leveraging data analytics of system performance to deliver reduced costs and increased efficiency
Lead user requirement gathering for operational needs and perform initial requirement assessments for MES modifications
Own CSV functions including defining requirements, writing and execution of test scripts
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
Monitor project schedule and escalate concerns to leadership with appropriate time to mitigate
Assist with drafting test plans for MES changes, including comprehensive test plans and/or reports for new recipes
Own MES-related deviations, including high-complexity or multi-site deviations relating to MES defects. Ensure corrective actions resolve issues effectively
Support MES-components of other site initiatives, including capitalized projects, tech transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new launches
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.