"Alerted.org

Position Overview

Fujifilm Diosynth Biotechnologies in Holly Springs, NC is hosting our second Manufacturing Hiring Event this Summer - INVITE ONLY.

Theseroleswill execute manufacturing processing steps and associated activities when operational.You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-newfacilitywill be 24/7 operational. We are hiring for night-specific roles; however, all roles may requires flexibility with working hours and/or shift.

We operate on a 2-2-3, 12 hour shift schedule and are hiring for NIGHT SHIFT ONLY.

Company Overview

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

We’re 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 we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

_What_** **_You’ll_** **_Do as a Manufacturing Associate:_

_During the project phase, you may:_

+ Participate and support testing activities, suchas:FAT, PQ etc.

+ Support and contributeinthepreparation of the documentation package(i.e.Standard Operating ProceduresandWork Instructions)

+ Contribute to the preparation for operational readiness related toWeigh and Dispense,bulkDrugSubstance orDrugProduct manufacturing

+ Possible assignmentsinclude,supporting projects related to procedure review and/or creation,developmentor transfer of manufacturing business processes, testing and commissioning support

+ This role is on a 2-2-3,12 hour shift schedule * _Must be flexible to night shift as part of your work schedule once in operations*_

_Once we are operational, you may:_

+ Lead, execute and document manufacturing processing steps and/or manufacturing support activities, processmonitoringand control

+ Perform operations offunctional area

+ Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)

+ Maintain compliance of GMP documents and ensureyourown training level is compliantand maintained

+ Support and/orassistsenior level associates or supervisor with scheduling daily activitiesfor your functional area, as needed

+ This role is on a 2-2-3,12 hour shift schedule (night shift)

+ Perform other duties asassigned

_What You’ll Do as a Supervisor:_

_Project Phase (Through Mid-2025)_

+ Supports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicable

+ Performs other operational readiness tasks as required, such as: document review/approval, team onboarding, and materials management

+ Supervises manufacturing associates on technical and operational topics, such as: area unit operations and equipment

+ Administers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employees

+ This role is on a 2-2-3,12 hour shift schedule * _Must be flexible to night shift as part of your work schedule once in operations*_

_Operations Phase (Starting Mid-2025)_

+ Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates

+ Coordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalations

+ Fosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reports

+ Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training

+ Supports manufacturing investigations and continuous improvement projects

+ Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipment

+ Administers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees

+ This role is on a 2-2-3,12 hour shift schedule (night shift)

+ Performs other job as assigned

Basic Requirements

+ **_Manufacturing Associate 2_**

+ High School Diploma or GED with 2 years of related experience in Life Sciences Manufacturing **OR**

+ Associate's Degree with 0 years of related experience **OR**

+ Equivalent Military training/experience

+ **_Manufacturing_** **_Associate 3_**

+ High School Diploma or GED with 4 years of related experience in Life Sciences Manufacturing **OR**

+ Associate's Degree with 2 years of experience in Life Sciences Manufacturing **OR**

+ BA/BS with 0 years of experience **OR**

+ Equivalent Military training/experience

+ **_Manufacturing Associate 4_**

+ High School Diploma or GED with6 years of experienceinLifeSciencesManufacturing **OR**

+ Associate degreewith 4 years’ experience inLifeSciencesManufacturing **OR**

+ BA/BS with 2 years of experience inLifeSciencesManufacturing **OR**

+ Equivalent Military training/experience

+ **_Manufacturing Associate 5_**

+ High School Diploma or GED with 8 years’ experience in a Life Sciences Manufacturing environment **OR**

+ Associate Degreewith 6 years’ experience in a Life Sciences Manufacturing environment **OR**

+ BA/BS, preferably in Life Sciences/Engineeringwith 4 years of experience in Life Sciences Manufacturing **OR**

+ Equivalent Military Experience

+ **_Supervisor, DSM (Upstream & Downstream)_**

+ High School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projects **OR**

+ Associate's Degree and 6 years of experience in Life Sciences Manufacturing **OR**

+ BA/BS and 4 years of experience in Life Sciences Manufacturing

Preferred Requirements

+ **_Manufacturing Associate 2_**

+ 2 Years of directexperience in a cGMP Manufacturing Environment

+ BioWorksor BTEC Capstone cGMP coursework preferred

+ **_Manufacturing Associate 3_**

+ Qualified Experience on Unit Operation (DPFG Filler or Cell Culture – Seed Train)

+ BioWorksor BTEC Capstone cGMP coursework preferred

+ **_Manufacturing Associate 4_**

+ Understanding of manufacturing run cadence and order of shift activities

+ Knowledge in cGMP, Safety and Operational Procedures

+ A high degree of knowledge andexpertiseof the operation of specific production equipment

+ BioWorkor BTEC Capstone cGMP Coursework Preferred

+ **_Manufacturing Associate 5_**

+ Proficient understanding of cGMP regulations and pharmaceutical industry standards

+ BioWorksor BTEC Capstone cGMP Coursework preferred

+ **_Supervisor, DSM (Upstream & Downstream)_**

+ Experience in manufacturing of biological products, familiar with GMP/GLP Requirements

+ Previous experience leading, supervising or managing others

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

+ Be exposed to an environment that maynecessitaterespiratoryprotection.

+ Be exposed to noisyenvironments.

+ Have a normal range of vision

+ Climb ladders and stairs of variousheights.

+ Experience prolonged sitting, standing, walking, bending,stoopingand stretching throughout the shift, up to 12hours.

+ Use hand-eye coordination and manual dexterity sufficient tooperatea computer keyboard, telephone, calculator, and other office equipment isrequired.

+ May berequiredtolift upto 50 pounds onoccasion.

_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 ([email protected]).

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

**Posted Date** _2 weeks ago_ _(5/6/2025 1:48 PM)_

**_Requisition ID_** _2025-34505_

**_Category_** _Manufacturing_

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