Senior Automation Engineer 1, MES

Position Overview

The Automation Senior Engineer 1, MES, provides support to the Drug Substance Manufacturing (DSM) facility. This includes implementing changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being part of Automation on-call support. This role will lead projects and handle complex changes while coordinating with other internal and external groups.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

• Spearheads the Automation team through activities, such as code configuration within several process areas and scope work
• Leads the development for various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
• Supports global alignment of our implemented capabilities, maintaining and protecting our global platform concept
• Leads the development for various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
• Plans and implements the technical direction for the area of responsibility
• Leads small teams through Automation changes and Tech Transfers
• Makes complex decisions across single Automation systems
• Contributes to Automation system hardware and software designs
• Serves as on-call support for Automation inquiries and troubleshooting
• Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
• Conducts training and presents information to the team or other stakeholders
• Other duties, as assigned

 

Knowledge and Skills

• Personal ownership and proactive collaboration with external business partners and internal stakeholders
• Effective communication, both written and oral
• Advanced problem-solving skills
• Ability to effectively present complex information to others
• Ability to provide feedback to others, including leaders
• Ability to remain up to date on regulatory and quality requirements for manufacturing

 

Basic Requirements

• Bachelor’s degree in a technical field of study relevant to Automation or Instrumentation & Controls with 8 years of Automation experience OR
• Master’s degree in a technical field of study relevant to Automation or Instrumentation & Controls with 6+ years of Automation experience.
• Prior experience with MES that includes understanding behavior code, ET Configuration, EM Configuration, DeltaV DCS Configuration concepts, and SC Consumer Execution Group Configuration.

Preferred

• Prior experience and exposure to modelling BPR and eBR recipe components in a Manufacturing Executing System
• Proficiency in the fundamental technologies used within DeltaV MES (Syncade), such as SQL Stored Procedures and xPath Matching.
• Previous experience within pharma/GMP experience

 

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection X No Yes

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes

Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes

Ability to discern audible cues. No X Yes

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes

Ability to stand fo