Manufacturing Support Associate 1, Drug Product (2 Openings) - Fujifilm

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB 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 FDB 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.

External US

About This Role

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

What You’ll Do 

• During the project phase, leads operational readiness initiatives as well as site commissioning and qualification efforts.
• Supports and participates troubleshooting for their respective process area.
• Performs documentation updates to support reliable production.
• Creates non-batch activities and associated documentation for tech transfer, changeover, preventive maintenance plans (PMs), column packing.
• Supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities to supports manufacturing.
• Supports Inspections and audits by providing requested manufacturing documents.
• Performs other duties as assigned.

Who You Are 

You will perform manufacturing support activities related to drug product and finished goods to ensure compliant and reliable production. You will support change management records, investigations, corrective and preventive actions, documentation updates and more.

Basic Requirements 

• High School Diploma or GED with 4 years related experience.
• Strong verbal and written communication skills
• Strong time management skills
• Ability to adapt in a fast-paced environment, pivot and adjust plans accordingly.
• Ability to think critically and have superior problem-solving skills.
• Team based attitude and ability to work in a global team environment, build relationships, and communicate effectively with others
• Ability to update and create documents per schedule.

Preferred Requirements

• Associate degree in life sciences with 2 yr. direct experience OR
• BA/BS in life sciences with no experience OR
• Equivalent Military experience
• Manufacturing operations experience
• Understanding of change management, investigations, CAPAs and CIs
• BioWorks or BTEC Capstone cGMP coursework preferred.

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Will work in environment which may necessitate respiratory protection X No Yes
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
• Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
• Ability to discern audible cues. No X Yes
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
• Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
• Ability to stand for prolonged periods of time. No X Yes 30 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
• minutes)
• Ability to sit for prolonged periods of time. No X Yes 30 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
• minutes)
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
• Ability to operate machinery and/or power tools. No X Yes
• Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.