Automation Engineer 3, MES (Syncade)

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled Automation Engineer 3 to support its cutting-edge Drug Substance Manufacturing facility. In this dynamic role, you will implement changes to automation systems, update design documents, and execute testing. As part of a collaborative team, you will help design and maintain the Manufacturing Execution System (MES), ensuring compliance with good manufacturing practices. This is a unique opportunity to contribute to the development of life-saving biopharmaceuticals in a state-of-the-art facility, where your expertise will play a pivotal role in shaping the future of healthcare.

Benefits

Health insurance

Retirement plan

Paid time off

Professional development

Flexible working hours

Qualifications

• 5 years of experience in Automation, Instrumentation & Controls.
• Knowledge of modeling BPR and eBR components in MES.

Responsibilities

• Perform Automation activities including code configuration and testing.
• Design and maintain the global MES platform.

Skills

Effective communication

Advanced problem-solving

Knowledge of Automation subject areas

Education

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in Electrical Engineering

Bachelor’s degree in Mechanical Engineering

Tools

DeltaV MES (Syncade)

Batch Production Record (BPR)

electronic Batch Record (eBR)

Job description

Position Overview

The Automation Engineer 3, 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 maintaining the Manufacturing Execution System (MES).

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a newlarge-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will alsoprovideautomated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description

What You’ll Do

• Performs Automation activities, such as code configuration, document development, and test execution within several process areas
• Delivers accurate and on-time Automation work
• Creates standard code utilizing complex control strategies
• Participates in designing and maintaining the global MES platform to accommodate for new capabilities.
• Assesses requirements and needs identified during Tech Transfers (TT) and participates in the implementation.
• Ensures good manufacturing practice (GMP) integrity of MES is maintained.
• Collaborates with Senior Engineers to develop (generate, review, maintain) various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
• Collaborates with Senior Engineers to develop (generate, review, maintain) various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
• Serves as on-call support for Automation inquiries and troubleshooting
• Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
• Other duties, as assigned

Knowledge and Skills

• Effective communication, both written and oral
• Advanced problem-solving skills
• Ability to effectively present information to others
• Ability to provide feedback to others, including leaders
• Ability to present and explain knowledge of several Automation subject areas to internal partners
• Knowledge of modeling Batch Production Record (BPR) and electronic Batch Record (eBR) recipe components in MES

Basic Requirements

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or other relevant field
• 5 years of Automation, Instrumentation & Controls, or other relevant technical experience

Preferred Requirements

• 3+ years of DeltaV MES (Syncade) experience (including exposure to behavior code, equipment tracking (ET) and event monitor (EM) configuration, basic DeltaV distributed control system (DCS) configuration concepts, SC consumer execution group configuration)
• Previous experience within a pharmaceutical or GMP environment

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 writs, 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

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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]).