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  • MES System Owner

    Avispa Technology (Hillsboro, OR)



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    MES System Owner ROCGJP00037172 * Hourly pay: $60-$70/hr * Worksite: Leading biotechnology company (Hillsboro, OR 97124 - Onsite) * W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL * 40 hours/week, 12 Month Assignment, Potential conversion A leading biotechnology company is seeking a MES System Owner to join the IT OT team. The successful candidate will contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape. MES System Owner Responsibilities: * Serve as the system owner/local product owner for manufacturing IT Applications in a 24x7 Good Manufacturing Practice (GMP) pharmaceutical manufacturing facility. * Oversee computer systems qualification and validation. * Address and mitigate global system application dependencies as global systems evolve their business processes and technologies (e.g., SAP upgrades, EDMS, LIMS integration). * Utilize the Agile delivery model, providing leadership, technical expertise, and local implementation experience as a member of Build and Run Squads. * Collaborate with site Business Process Owners to manage system upgrades, patches, and changes, ensuring GMP compliance. MES System Owner Qualifications: * 5+ years of experience implementing and managing Manufacturing Systems solutions, preferably Rockwell PharmaSuite, or demonstrated experience that will facilitate rapid learning on the relevant platforms. * MES System experience in manufacturing. * Holds a Bachelor's Degree in Informatics, Engineering, or equivalent. * Experience in 24x7 support, and ability to participate in an on-call environment to meet business continuity requirements, including weekends and holidays if required. * Experienced in the Biopharmaceutical or similar Manufacturing domains. * Experience with batch management and a distributed control system. * Experience with Microsoft SQL Server, SQL Scripting, and SQL Troubleshooting. * Experience working closely with IT/OT providers and vendors. * Experience in the life sciences Manufacturing domain. * Proficient in informational and operational technologies (IT/OT), with expertise in MES integration and interfaces to enterprise global systems. * Knowledgeable about Manufacturing Execution Systems (Preferably PharmaSuite), LIMS, PI Data Historian, Quality Management Systems (Preferably Veeva and ValGenesis), ERP, etc. * Familiar with new product introduction and manufacturing operations as they apply to all Manufacturing Systems. * Stays updated with key trends in Manufacturing IT, and maintains curiosity about Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data * Integrity principles, Technology, and data standardization, among other topics. * Exhibits the behaviors of a Lean-Agile Leader, with a Lean-Agile mindset. * Knowledgeable of Good Manufacturing Practices (GMP), Health Authority practices, 21CFR Part 11, cGMP Annex 11, and Data Integrity principles. Shift: * 8 am -5 pm are typical working hours. Must be flexible to take after-hours calls, including weekends and holidays if required.

     


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