Manufacturing Support Associate 2

Position Overview

This role will perform manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours. 

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 the project phase, you will lead operational readiness initiatives as well as site commissioning and qualification efforts
• Lead troubleshooting for their respective process area
• Recommend and perform documentation updates
• Coordinate non-batch activities and creation of associated documentation for tech transfer, changeover, preventive maintenance plans (PMs), column packing
• Create change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities to support manufacturing
• Execute and drive general improvement projects within Drug substance manufacturing
• Work with cross-functional groups to organize equipment startup and transfer into GMP manufacturing
• Support Inspections and audits by providing requested manufacturing documents 
• Other duties as assigned 

Basic Requirements

• High School Diploma or GED and 6 years of related experience ORAssociates degree with 4 years of direct experience OR
• BA/BS with 2 years of direct experience
• Equivalent Military training/experience

 Preferred Requirements

• Associates or Bachelor’s in life sciences or engineering
• BioWorks or BTEC Capstone cGMP coursework preferred

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

• Ability to discern audible cues

WORKING ENVIRONMENT

PHYSICAL DEMANDS  

• 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 wrist, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 lbs.

ENVIRONMENTAL CONDITIONS

• Will 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).