Job Details

Job Title: Manufacturing Execution System Recipe Author

Job Location: 4625 NE Brookwood Parkway, Hillsboro, OR 97124

Duration: 10 months contract with possibility of extension or conversion

Note: Job duties will be performed on-site in Hillsboro, Oregon.

Job Description:

The ITOT Team in Hillsboro is supporting Hillsboro Technical Operations (HTO) which is the commercial Make Assess and Release (MAR) and launch site for North America and Hillsboro Individualized and Cell Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.

The role will support Hillsboro Technical Operations (HTO), located in Hillsboro Oregon, which is a Drug Product manufacturing facility (Component Prep & Compounding, Liquid/Lyophilized Filling, automated/Manual Inspection, Packaging/Finished Products and Distribution.) This role would perform Recipe Author activities for the operations that utilize MES in support of Tech Transfer projects.

Responsibilities:

• Manufacturing Execution System (MES) (PharmaSuite) recipe authoring and software development
• Troubleshooting plant floor MES execution and business system integration issues
• Compliance with corporate and site business processes, valid design principles, and quality procedures
• Qualification test plan development/review/approval and execution
• Implementing production tech transfer requirements into MES system
• Knowledge on batch record structure and exception handling, with sharing among the broader project team and affected site personnel
• Understanding of the Core practices that need to be adopted at the site, including recipe requirement documentation, validation, project deliverables such as project and implementation plans, etc.
• Development of recipe and workflow requirement specifications, formal design specifications of system master data configuration.
• Create, as directed by Genentech, project-specific documentation required for implementation.
• Creation and finalizing recipe requirement specifications for all recipes and workflows
• Contributing to the development and optimization of departmental and site business processes
• Provide Consulting with Business Process owners in the Value Streams
• Contribute with MES Recipe Authoring knowledge to Projects/Squads for MES Projects, process improvement initiatives or support

Qualifications / Requirements:

• A BS/MS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent
• A minimum of 5 to 7 years of manufacturing execution systems experience, preferably PharmSuite
• Strong interpersonal communication skills
• Project management skills
• Ability to multi-task while handling routine and impromptu assignments with minimal supervision
• Must be able to plan and perform testing, including documenting test conditions, expected results, and test validation
• Must be comfortable working under pressure, delivering quality results with schedule deadlines and have a proven track record in meeting schedule for tasks while still meeting or exceeding business requirements and goals
• Work autonomously direct with Engineering and Value Streams
• Work with Global Recipe Authors Team on common templates for PharmaSuite MES
• Job duties include after hours on call support at least one week a month