Senior Automation Engineer 2

1 week ago


Raleigh, North Carolina, United States FUJIFILM Diosynth Biotechnologies Full time
About This Role

The Senior Automation Engineer 2, MES, plays a crucial role in supporting Drug Substance Manufacturing (DSM) at FUJIFILM Diosynth Biotechnologies. This position involves implementing changes to Automation systems, updating design documents, executing testing, troubleshooting events, and participating in Automation on-call support.

This role leads projects and handles complex changes while coordinating with internal and external groups. The successful candidate will spearhead the Automation team through activities such as code configuration within process areas and scope work.

Key Responsibilities
  • Lead the development of various specification documents, including user requirements specification (URS), functional specification (FS), design qualification (DQ), and others.
  • Drive and coordinate global alignment of implemented capabilities, maintaining and protecting the global platform concept.
  • Develop and implement test protocols and functional testing documents, such as installation qualification (IQ), operational qualification (OQ), and others.
  • Plan and implement the technical direction for medium areas of responsibility.
  • Lead medium cross-functional teams through Automation projects.
  • Make complex decisions across single Automation systems.
  • Design Automation systems hardware and software, ensuring consistency across platforms.
  • Provide on-call support for Automation inquiries and troubleshooting.
  • Collaborate with other departments, such as Manufacturing, Maintenance, and Validation.
  • Conduct training and present information to teams or other stakeholders.
  • Provide mentorship to other Engineers, as needed.
Requirements
  • Bachelor's degree in a technical field of study relevant to Automation or Instrumentation & Controls with 12 years of Automation experience, or Master's degree with 8+ years of Automation experience.
  • Extensive experience with DeltaV MES (Syncade), including understanding behavior code, ET Configuration, EM configuration, DeltaV DCS configuration concepts, and SC consumer execution group configuration.
  • Proficiency in fundamental technologies used within DeltaV MES (Syncade), such as SQL Stored Procedures and xPath Matching.
  • Previous experience within pharma/GMP.
  • Personal ownership and proactive collaboration with external business partners and internal stakeholders.
  • Ability to define Automation standards and share across sites.
  • Effective communication, both written and oral.
  • Advanced strategic thinking skills.
  • Ability to effectively present complex information to others.
  • Ability to remain up-to-date on regulatory and quality requirements for manufacturing.
  • Ability to train or mentor others.
Preferred Requirements
  • Prior experience and exposure to modeling BPR and eBR recipe components in a Manufacturing Executing System.


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