Manufacturing Specialist 1, Drug Product

Position Overview

The Manufacturing Specialist 1 DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24 / 7 manufacturing facility.

Company Overview

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

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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 : Description

What Youll Do

During the project phase support operational readiness initiatives as well as site commissioning and qualification efforts

Supports trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)

Coordinates Batch Planning including process template creation and import and management of Preventative Maintenance (PMs)

Owns performs or drives documentation major documentation updates (i.e. Initiates new documents for new processes)

Coordinates non-batch activities (e.g. Changeover PMs Aseptic Process Simulation APS)

Supports the MSAT group with tech transfer within manufacturing

Ensures compliance and safety procedures are followed in manufacturing environment

Create and updates Electronic Batch Records (EBRs) and Paper Batch Records

Manages performs initiates or supports change management records investigations Corrective and Preventive Actions (CAPAs) and Continuous Improvement (CI) activities

Manages projects leads execution and participates in projects within Drug Product Finished Goods

Assists and supports inspections and audits providing support to ensure compliance within the manufacturing environment

Assists Manager with projects and training as needed

Other duties as needed

Basic Requirements

High School Diploma or Equivalent with 9 years of applicable industry experience OR

Bachelors degree with 5 years of applicable industry experience OR

Masters degree 3 years of applicable industry experience OR

PhD without experience OR

Equivalent Military Experience

Preferred Requirements

High degree of understanding of operations sequence and cadence of activities in a manufacturing environment

Bio Works or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Will work in environment which may necessitate respiratory protection
• May work in Mechanical / Production spaces that may require hearing protection and enrollment in a hearing conservation program
• Will work in environment operating a motor vehicle or Powered Industrial Truck
• Ability to discern audible cues
• Ability to inspect or perform a task 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 of time
• Ability to sit for prolonged periods of time
• 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
• Will work in warm / cold environments

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 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 ().

Required Experience :

IC

Key Skills

Sales Experience,Marketing,Customer Service,Communication skills,Military Experience,Retail Sales,Product Demos,Customer Support,Product Management,Product Development,Unity,Microscopy

Employment Type : Unclear

Department / Functional Area : Manufacturing

Experience : years

Vacancy : 1