Sr Automation Engineer 1, MES

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina seeks a Sr Automation Engineer 1, MES to support Drug Substance Manufacturing. You will manage automation changes, update design docs, test troubleshooting events, and help design and maintain the MES.

You will lead the Automation team, develop specification documents (URS/FS/DQ), and participate in on-call support and cross-department collaboration with Manufacturing, Maintenance, and Validation.

Qualifications

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or related field.
• 8 years of Automation, Instrumentation & Controls or related experience.
• Master’s degree with 6+ years in Automation/Instrumentation & Controls.
• Exposure to MES with DeltaV DCS configuration concepts.
• Preferred: modelling BPR/eBR components in MES; pharma/GMP experience.

Responsibilities

• Lead Automation team activities and DeltaV configuration across processes.
• Develop URS/FS/DQ documents.
• Lead testing protocols (IQ/OQ) and validation activities.
• Plan technical direction and coordinate small team changes.

Skills

Automation expertise

Cross-functional collaboration

Communication skills

Problem solving

Leadership

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

DeltaV DCS

DeltaV MES (Syncade)

SQL Stored Procedures

xPath Matching

Job description

Position Overview

The Sr Automation Engineer 1, MES provides support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. Additionally, this role participates in designing and maintain the Manufacturing Execution System (MES).

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 using DeltaV
• 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 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 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 Chemical, Electrical, or Mechanical Engineering or other relevant field
• 8 years of Automation, Instrumentation & Controls, or other relevant technical experience
• Master’s degree in technical field of study relevant to Automation or Instrumentation & Controls with 6+ years of Automation experience.
• Prior experience with MES that includes exposure to understanding behavior code, ET Configuration, EM configuration, DeltaV DCS configuration concepts, 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 YesMay 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 YesAbility 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 YesAbility to stand for prolonged periods of time. No X Yes 30 minutesAbility to sit for prolonged periods of time. No X Yes 240 minutesAbility to conduct activities using repetitive motions that include wrists, hands, and/or fingers. No X YesAbility to operate machinery and/or power tools. X No YesAbility to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).