Title: Manufacturing Execution System Recipe Author, Req#: ROCGJP00029090

Location: Hillsboro, OR (100% onsite)

Duration: 10+ months Contract (by the end of the year)

Job Description:

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 the MES system
• Knowledge of 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 the client, 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 directly with Engineering and Value Streams
• Work with the Global Recipe Authors Team on common templates for PharmaSuite MES
• Job duties include hours on-call support at least one week a month