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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.

Job Description

What You’ll 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 ContinuousImprovement (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**

• Bachelor’s degree with 5 years of applicable industry experience **OR**

• Master’s 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 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._

**Job Locations** _US-NC-Holly Springs_

**Posted Date** _3 weeks ago_ _(10/6/2025 3:46 PM)_

**_Requisition ID_** _2025-35831_

**_Category_** _Manufacturing_

**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_