MES CHANGE SPECIALIST

Location: Hillsboro, OR | Category: Manufacturing | Employment: Contract | Worksite: On-Site

About the role

As part of the Process and Compliance Team in manufacturing, 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.

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
• Translate operational requirements into recipe and workflow requirements that will define CSV test protocols
• Development, authoring, and executing of protocols for configuration verification (CV) and functional verification (FV) testing of MES recipes and workflows according to approved procedures and CSV principles
• Investigate and assess exceptions and deviations from CV and FV protocol testing
• 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

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
• 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 for 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 (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 with troubleshooting Rockwell systems, including remote or on-site support (strongly preferred)
• Prior experience on an EBR or MES deployment projects (preferred)

Pay

Pay Rate Range: 55-68/hr depending on experience