Responsible for enhancement, maintenance, administration, and qualification of the plant's Manufacturing Execution System (MES) and its associated interfaces to upstream and downstream systems in support of various site initiatives and projects. This includes authoring and maintaining GMP/Non-GMP documentation, change control, and departmental support processes and procedures. Candidate must be willing to work extended hours as needed to support internal customers including supporting 24x7 site operations.
MES recipe authoring and software development.
System lifecycle documentation creation and updates.
Test script authoring, dry runs, and formal execution to maintain the system’s validated state.
Authoring and assessment of change records related to system modifications.
Troubleshooting plant floor MES execution and business system integration issues.
Development of solutions that extend the existing system capabilities to provide or improve production and operational analysis tools, batch review/release, equipment automation integration, and business system integration.
Contributing to the development and optimization of departmental and site business processes such as configuration management, tech transfer execution, change implementation and testing, and release management.
Provide oversight of vendors and deliver guidance to support project implementations that require MES.
3-5 years of hands-on experience with Emerson’s Syncade platform (recipe authoring, behavior development, stylesheets, etc.) and/or Rockwell’s PharmaSuite or PMX platforms, with system change experience preferred.
Theoretical and applied knowledge of S88 batch programming, validation, and GMP regulations applicable to automation computer systems.
Strong initiative and integrity as well as strong written and verbal communication skills.
Must demonstrate an ability to apply solutions and troubleshoot complex problems on highly automated equipment to address business needs.
Must have experience working in regulated industries such as Pharmaceutical, Medical Device, or Food and Beverage.
Must be able to successfully work independently and within teams.
B.S or M.S. in Engineering, Computer Science, or equivalent degree.
Sound understanding of Good Manufacturing Practices (cGMPs), particularly as they relate to the operation, validation and maintenance of computerized systems, information systems, and electronic records.
Experience with Visual Basic scripting, .NET programming, and/or Java a strong plus
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
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