Manufacturing Specialist 2, MES & DCS

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Manufacturing Specialist 2 to support operations in a cutting-edge biopharmaceutical facility. This role involves recipe configuration, troubleshooting, and ensuring compliance within a fast-paced manufacturing environment. You will be part of a dynamic team dedicated to producing life-changing therapies, with opportunities for professional growth and development. Join a mission-driven organization that values innovation and collaboration, and make a tangible impact in the world of biopharma manufacturing. If you're ready to take on a challenging and rewarding role, this opportunity is for you!

Qualifications

• 12+ years of life sciences or automation experience required.
• Experience with DeltaV DCS or similar system is a must.

Responsibilities

• Execute simulations and troubleshoot within DeltaV DCS and MES.
• Support inventory management and develop necessary business processes.

Skills

Manufacturing Operations

Troubleshooting

Recipe Configuration

Technical Support

Cross-Functional Collaboration

Education

High School Diploma or GED

Associate’s Degree in Life Sciences or Engineering

Bachelor’s Degree in Life Sciences or Engineering

Tools

DeltaV DCS

DeltaV MES

Job description

Position Overview

The Manufacturing Specialist 2, MES & DCS performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to DeltaV Distributed Control Systems (DCS) and Manufacturing Execution System (MES). The manufacturing facility will be 24/7 operational and the role may require flexibility with working hours and shift rotation.

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 new large-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 solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated 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

1. Executes simulations (e.g., set-up and troubleshooting within DeltaV DCS and DeltaV MES, and recipe authoring)
2. Supports inventory management within DeltaV MES technically
3. Develops business processes as needed (e.g., configuration, troubleshooting transaction issues, and definition of required automation updates)
4. Owns MES/DCS system owner evaluations on behalf of DSM for local and global change controls
5. MES/DCS capability steward, assessing incoming processes against existing capability and translating that into capability change requests (e.g., initial assessment, detailed assessment during tech transfer)
6. Partners cross functionally, internally and across sites, to ensure consistency in application of major and minor updates to MES
7. Provides technical support and troubleshooting related to DCS and MES internally for DSM
8. Trains and mentors DSM Documentation and support staff to support recipe configuration and trouble shooting
9. Performs and supports configuration of text resources via Resource Editor
10. Drives documentation creation or updates related to recipe configuration
11. Supports tech transfer within manufacturing domain
12. Initiates, performs, and manages change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities
13. Assists inspections and audits, providing support to ensure compliance within the manufacturing environment
14. Performs other duties, as assigned

Basic Requirements

• High school diploma or GED with 12+ years of life sciences or automation experience OR
• Associate’s degree in life sciences or engineering with 10+ years of related experience OR
• Bachelor’s degree in life sciences or engineering with 8+ years of related experience OR
• Equivalent/Relevant Military experience
• 4 years' experience configuring, testing, or troubleshooting within DeltaV DCS or similar system
• Strong manufacturing operations experience, with understanding of operations sequence and cadence of activities

Preferred Requirements

• Bachelor’s degree in life sciences or engineering
• Bio Works or BTEC Capstone cGMP coursework

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 committed to 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]).