MES Engineer
About The Position
This position, based in Genentech's Hillsboro, Oregon facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The IT OT 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 Innovative Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies. As part of the Hillsboro IT OT team, you will report to the Manufacturing Systems Development Lead to support the Manufacturing Execution System (MES) as a Recipe Author, designing, building, validating, and troubleshooting MES recipes in support Make/Assess/Release in a 24x7 Goods Manufacturing Practice (GMP) environment. As part of the Site Team and larger Global IT OT organization, you will also be expected to contribute to Manufacturing Operations Management initiatives and optimization/standardization of the global IT OT landscape.
Requirements
- A BS/MS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent
- A minimum of 2-4 years of relevant experience
- 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 Rockwell PharmaSuite MES
- Job duties include after hours on call support at least one week a month
Nice To Haves
- MES Recipe Authoring experience preferred
Responsibilities
- Manufacturing Execution System (MES) Rockwell (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 automation IT systems
- Contribute to the development of solutions for reporting, production and operational analysis tools, recipe procedural enhancements, batch review/release, equipment automation integration, and business system integration
- Present system and electronic batch record process to health authorities
- Contributing to development of supply chain network MES standards and best practices
- 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
- Participate in an after hours on-call support rotation
- Document system changes and incidents in ServiceNow
- Own and manage Change records and Deviation in Veeva Quality System
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Relocation benefits are not available for this job posting.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
