MES System Owner

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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