MES System Owner - Hillsboro

Only for registered members Hillsboro, United States

2 weeks ago

Full time $95,200 - $176,800 (USD)

Job summary

Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? Are you curious to shape a digital manufacturing architecture ready to advance competitiveness on the market This role could be for you We Make Medicines Behind every product sold by Roche is Pharma Global Technical Operations PT Starting with Phase I of the development process and continuing through to product maturity PT makes lifesaving medicines at 11 locations with the support of partners from around the world Information IT and Automation Technology teams are key in producing and delivering medicine to patients The organization is currently undergoing a transformation towards digitalization advancing fundamental elements to meet future needs such as using new technologies The Opportunity As part of the Hillsboro IT OT team you will report to the ITOT Infrastructure and Manufacturing Systems Lead take System Ownership local Product Ownership accountabilities for MES system ensuring robust support for Product Transfers Make/Assess/Release in a 24x7 Goods Manufacturing Practice GMP environment Primary Responsibilities Serve as System Owner Local Product Owner for Manufacturing IT Applications in a 24x7 Good Manufacturing Practice Pharmaceutical Manufacturing Facility Oversee entire system lifecycle of MES system Rockwell PharmaSuite including procurement design documentation development integration modification operation maintenance retirement Oversee computer systems qualification validation Address mitigate global system application dependencies as global systems evolve their business processes technologies e g SAP upgrades EDMS LIMS integration Collaborate site Business Process Owners manage system upgrades patches changes ensuring GMP compliance Define criticality quality requirements partnership Delivery Service Managers appropriate service levels disaster recovery procedures governance change management compliance operational support Lead coordinate technical discussions vendor negotiations Utilize Agile delivery model providing leadership technical expertise implementation experience Build Run Squads Support inspection readiness internal external regulatory audits Who You Are Bachelor s Degree Informatics Engineering equivalent Minimum years experience implementing managing Manufacturing Systems solutions preferably Rockwell PharmaSuite demonstrated experience facilitate rapid learning relevant platforms Ability participate on call environment business continuity requirements weekends holidays required Experienced Biopharmaceutical similar domains Proficient informational operational technologies expertise MES integration interfaces enterprise global systems Knowledgeable About Execution Systems Preferably PharmaSuite LIMS PI Data Historian Quality Management Systems Preferably Veeva ValGenesis ERP etc Familiar New Introduction operations apply all Manufactruing Systems Exhibits behaviors Lean-Agile Leader Lean-Agile mindset Knowledgeable Good Practices Health Authority practices cGMP Annex Data Integrity principles Experience batch management distributed control SQL Server SQL Scripting Troubleshooting Proven track record working closely providers vendors Expected salary range based Oregon primary location $95 000 - $176 800 Actual pay determined experience qualifications geographic location permitted law Discretionary annual bonus available individual Company performance Position qualifies benefits detailed link provided below Benefits Relocation benefits not available this posting Genentech equal opportunity employer Policy practice employ promote treat any employees applicants merit qualifications competence companys policy prohibits discrimination consistent federal state local laws If have disability need accommodation online application process please contact completing form Accommodations Applicants}

Job description

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