What are the responsibilities and job description for the MES (Manufacturing Execution System) ENGINEER position at Maxis Clinical Sciences?
Job Description
Job Description
MES ENGINEER (Contract)
Onsite in Hillsboro, Oregon Location
Day Shift-Monday to Friday, 8 : 00am to 4 : 30pm
Contract end date 12 / 31 / 25 (possible contract extensions up to 36 months)
The Position
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 performs 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, 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 :
Job duties will be performed on-site in Hillsboro, Oregon.
Company Description
Maxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12 years of average experience.
Our popular service niches that earned us global accolades are : clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
Company Description
Maxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12 years of average experience. Our popular service niches that earned us global accolades are : clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.
