Welcome page Returning Candidate? Log back in! Manufacturing Specialist 1 Job Locations US-NC-Holly Springs Posted Date 19 hours ago(1/23/2025 4:22 PM) Requisition ID 2025-33201 Category Manufacturing Company (Portal Searching) FUJIFILM Diosynth Biotechnologies Overview

The Manufacturing Specialist 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be 24/7 operational and the role may require to be flexible 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

 

During Project Phase:

Supports operational readiness initiatives as well as site commissioning and qualification efforts

In Operations:

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, import and management of preventative maintenance (PMs)Maintains current and accurate documentation, ensuring timely updates of records (redlines and process improvements)Coordinates of non‐batch activities including Changeover, PMs and column packing  Assists in inventory management and offers support in utilizing SAP for effective manufacturing operationsSupports tech transfer within manufacturing domainEnsures compliance and safety procedures are followed in manufacturing environmentManages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activitiesIdentifies and/or drives improvement projects in drug substance manufacturingAssists and supports inspections and audits.  Provides support to ensuring compliance within the manufacturing environmentOther duties as assigned

Basic Requirements

High School Diploma/GED and 10 years of related experience ORAssociate’s degree, preferably in life sciences or engineering with 8 years of direct experience ORBachelor’s degree preferably in life sciences or engineering with 6 years of direct experience OREquivalent Military experience/training

Preferred Requirements

Strong cGMP manufacturing operations experienceUnderstanding of operations sequence and cadence of activitiesPrior experience in updating and creating manufacturing documents per scheduleBioWorks or BTEC Capstone cGMP coursework preferred

Physical Requirements & Working Environment

Ability to discern audible cuesAbility to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of time - up to 120 minutesAbility to sit for prolonged periods of timeAbility to conduct activities using repetitive motions that include writs, hands and/or fingersAbility to conduct work that includes moving objects up to 10 poundsWill work in heights greater than 4 feet

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 (FDBN_PNC@fujifilm.com).

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