MES Automation Engineer - PharmaSuite & GMP

Genentech

Hillsboro (OR)

On-site

USD 79,000 - 177,000

Full time

2 days ago
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Job summary

Genentech in Hillsboro, Oregon seeks an Information Technology and Automation Technology professional to author MES recipes and support a highly automated drug substance facility. You will design, validate, and troubleshoot MES recipes in a GMP 24x7 environment, reporting to the Manufacturing Systems Development Lead and collaborating with global IT OT teams.

The role requires a BS/MS in engineering or CS and 2–4 years of relevant experience, including project management and testing.

Qualifications

  • BS/MS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent.
  • 2-4 years of relevant experience.
  • MES Recipe Authoring experience preferred.
  • Project management skills.
  • Ability to multi-task while handling routine and impromptu assignments.
  • Plan and perform testing with documented results.

Responsibilities

  • MES Rockwell (PharmaSuite) recipe authoring and software development.
  • Troubleshoot MES execution and system integration issues.
  • Ensure compliance with processes, principles and quality procedures.
  • Develop qualification test plans and approve executions.
  • Implement production tech transfer requirements into automation IT systems.
  • Develop reporting/analytics tools and support batch review/release.
  • Present system and electronic batch records to health authorities.
  • Contribute to MES standards and best practices.
  • Provide consulting with Business Process owners.
  • Support after-hours on-call rotation.
  • Document changes and incidents in ServiceNow.
  • Manage Change records and Deviations in Veeva Quality System.

Skills

MES Recipe Authoring
Project management
Testing/validation
Multi-tasking under pressure
Autonomy in engineering collaboration

Education

BS/MS in Chemical, Electrical, Mechanical Engineering, Computer Science or equivalent
Experience: 2-4 years

Tools

Rockwell PharmaSuite
Veeva Quality System
ServiceNow

Job description

Genentech in Hillsboro, Oregon seeks an Information Technology and Automation Technology professional to author MES recipes and support a highly automated drug substance facility. You will design, validate, and troubleshoot MES recipes in a GMP 24x7 environment, reporting to the Manufacturing Systems Development Lead and collaborating with global IT OT teams.

The role requires a BS/MS in engineering or CS and 2–4 years of relevant experience, including project management and testing.

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