Automation Engineer 2, MES
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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 deliver the next vaccine, cure, or therapy. Holly Springs combines small-town warmth with proximity to Raleigh’s thriving tech scene.
About the role
This position provides support to the Drug Substance Manufacturing (DSM) facility, including implementation of changes to Automation systems, updating design documents, executing testing, troubleshooting events, and participating in Automation on-call support. Additionally, this role participates in designing and maintaining the Manufacturing Execution System (MES).
Responsibilities
- Spearhead the Automation team through activities such as code configuration within several process areas and scope work using DeltaV.
- Lead the development of various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.).
- Support global alignment of implemented capabilities, maintaining and protecting our global platform concept.
- Lead the development of various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.).
- Plan and implement the technical direction for area of responsibility.
- Lead small teams through Automation changes and Tech Transfers.
- Make complex decisions across single Automation systems.
- Contribute to Automation system hardware and software designs.
- Serve as on-call support for Automation inquiries and troubleshooting.
- Collaborate with other departments, such as Manufacturing, Maintenance, and Validation.
- Conduct training and present information to team or other stakeholders.
- Perform other duties as assigned.
Requirements
- Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or other relevant field.
- 2 years of Automation, Instrumentation & Controls, or other relevant technical experience.
Preferred Qualifications
- 3+ years of DeltaV MES (Syncade) experience, including exposure to behavior code, equipment tracking (ET), event monitor (EM) configuration, basic DeltaV distributed control system (DCS) configuration concepts, and SC consumer execution group configuration.
- Previous experience within a pharmaceutical or GMP environment.
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.
Working Conditions & Physical Requirements
- May work in environments that necessitate respiratory protection.
- May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
- May operate a motor vehicle or Powered Industrial Truck.
- Ability to discern audible cues.
- Ability to inspect or perform tasks with 20/20 corrected vision, visual acuity, including distinguishing color.
- Ability to ascend or descend ladders, scaffolding, ramps, etc.
- Ability to stand for prolonged periods (30 minutes).
- Ability to sit for prolonged periods (240 minutes).
- Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
- Ability to operate machinery and/or power tools.
- Ability to conduct work that includes moving objects up to 33 pounds.
- Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.