MES Change Specialist

MES Change Specialist ROCGJP00043352

• Hourly pay: $70/hr
• Worksite: Leading biotechnology company (Hillsboro, OR 97124- Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 8 Month Assignment (With possibility of extension)

A leading biotechnology company is seeking an MES Change Specialist to design, test, validate, and maintain Manufacturing Execution System (MES) electronic documentation for a highly automated pharmaceutical production and packaging facility.

MES Change Specialist Responsibilities:

• Lead user requirement gathering and initial assessments for MES modifications, translating operational requirements into recipe and workflow requirements that define CSV test protocols, and work cross-functionally with manufacturing, process and compliance, IT/OT, master data, and other departments.
• Own computerized system validation (CSV) functions, including defining requirements, writing and executing test scripts, and developing, authoring, and executing configuration verification (CV) and functional verification (FV) protocols for MES recipes and workflows. Investigate exceptions and deviations from protocol testing, and help draft comprehensive test plans and reports for MES changes and new recipes.
• Own the planning, execution, and continuous improvement of MES change reviews for assigned manufacturing processes through the change management process, including testing and implementation, while monitoring project schedules and escalating concerns to leadership in time to mitigate them.
• Own MES-related deviations, including high-complexity or multi-site deviations tied to MES defects, ensuring corrective actions resolve issues effectively. Troubleshoot mechanical or automation-related production failures, and use data analytics on system performance to identify improvements that reduce costs and increase efficiency.
• Support the MES components of other site initiatives, including capital projects, tech transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new launches, and serve as MES audit support by providing demonstrations, presentations, and answers and supporting closure of MES-related regulatory findings.

MES Change Specialist Qualifications:

• 3-5 years of MES, electronic batch record, or computerized systems experience in regulated manufacturing with a Bachelor's degree in a relevant field; OR
• Master's degree in a relevant field.
• Experience with the construction, testing, and validation of computerized systems.
• Extensive experience working in electronic change management systems, such as TrackWise or Veeva, owning changes from initiation to closure and coordinating action items across multiple departments.
• 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, MES, Programmable Logic Controllers (PLC), and Human Machine Interfaces (HMI).
• Experience with sterile pharmaceutical manufacturing, such as solution prep, equipment prep, liquid/lyo vial filling, PFS, formulation, inspection, and packaging.
• Experience troubleshooting Rockwell systems, including remote or onsite support, is preferred.
• Prior experience on EBR or MES deployment projects is preferred.

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