MES Change Specialist

About the role

Hillsboro Technical Operations (HTO) is a drug product and finished goods manufacturing organization within Roche, producing millions of units of medicine each year. As part of the Process and Compliance team, the MES Change Specialist designs, builds, tests, validates and maintains electronic documentation for operations across HTO's highly automated production and packaging facility, working cross-functionally with manufacturing, P&C, ITOT, master data and others.

Key responsibilities

• Troubleshoot and resolve mechanical or automation-related failures in production
• Identify efficiency improvements using data analytics of system performance
• Lead user requirement gathering and initial assessment of MES modification requirements
• Own CSV functions, including defining requirements, writing and executing test scripts
• Plan, execute and improve the review of MES changes for assigned manufacturing processes, including testing and implementation
• Monitor project schedules and escalate concerns to leadership
• Assist with drafting test plans and reports for MES changes and new recipes
• Own MES-related deviations, including high-complexity or multi-site ones, and ensure corrective actions resolve them
• Support MES components of site initiatives such as tech transfers, DS/DP changes, shutdowns and new launches
• Serve as audit support for MES, including demonstrations, presentations and regulatory finding closure

Required profile

• Bachelor's degree in a relevant field plus 3-5 years of MES, electronic batch record or computerized systems experience for regulated manufacturing, or a Master's degree
• Prior experience constructing, testing and validating computerized systems
• Extensive experience with electronic change management systems (e.g., TrackWise, Veeva)
• Experience owning changes in a change management system from initiation to closure
• Prior experience on EBR or MES deployment projects preferred
• Experience troubleshooting Rockwell systems, including remote or on-site support, strongly preferred

Required skills

• Strong understanding of test requirements for electronic data systems for regulatory compliance
• Knowledge of SAP, MES, PLC and HMI automation systems
• Prior experience in sterile pharmaceutical manufacturing (solution prep, equipment prep, vial filling, PFS, formulation, packaging, etc.)

What we offer

• Salary range of $79,000 - $146,000 for the Hillsboro location, depending on experience and qualifications
• Discretionary annual bonus based on individual and company performance
• Relocation benefits and the benefits described in the company's benefits page