Manufacturing Specialist 1 - Production Scheduling

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.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll 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 nonbatch activities including Changeover PMs and column packing
• Assists in inventory management and offers support in utilizing SAP for effective manufacturing operations
• Supports tech transfer within manufacturing domain
• Ensures compliance and safety procedures are followed in manufacturing environment
• Manages performs initiates or supports change management records investigations corrective and preventive actions (CAPAs) and continuous improvement (CI) activities
• Identifies and/or drives improvement projects in drug substance manufacturing
• Assists and supports inspections and support to ensuring compliance within the manufacturing environment
• Other duties as assigned

Basic Requirements

• High School Diploma/GED and 10 years of related experience OR
• Associates degree preferably in life sciences or engineering with 8 years of direct experience OR
• Bachelors degree preferably in life sciences or engineering with 6 years of direct experience OR
• Equivalent Military experience/training

Preferred Requirements

• Strong cGMP manufacturing operations experience
• Understanding of operations sequence and cadence of activities
• Prior experience in updating and creating manufacturing documents per schedule
• BioWorks or BTEC Capstone cGMP coursework preferred

Physical Requirements & Working Environment

• Ability to discern audible cues
• Ability to ascend or descend ladders scaffolding ramps etc.
• Ability to stand for prolonged periods of time up to 120 minutes
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include writs hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds
• 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 viaemail 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.

Fujifilm is committedto 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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .