Manufacturing Hiring Event

Position Overview:

Fujifilm Diosynth Biotechnologies in Holly Springs, NC is hosting a Manufacturing Hiring Event this Spring - INVITE ONLY.

We will have a day shift and a night shift. 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 (days and nights).

Company Overview:

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

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

This will be the largest end-to-end cell culture CDMO provider in North America.

The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description:

What You’ll Do as a Manufacturing Associate:

During the project phase, you may:

• Participate and support testing activities, such as: FAT, PQ etc.
• Support and contribute in the preparation of the documentation package (i.e. Standard Operating Procedures and Work Instructions)
• Contribute to the preparation for operational readiness related to Weigh and Dispense, bulk Drug Substance or Drug Product manufacturing
• Possible assignments include, supporting projects related to procedure review and/or creation, development or 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, process monitoring and control
• Perform operations of functional area
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Maintain compliance of GMP documents and ensure your own training level is compliant and maintained
• Support and/or assist senior level associates or supervisor with scheduling daily activities for your functional area, as needed
• This role is on a 2-2-3,12 hour shift schedule (days or nights)
• Perform other duties as assigned

What You’ll Do as a Supervisor:

• 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*

• 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 (days or nights)
• Performs other job as assigned

• 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 with 6 years of experience in Life Sciences Manufacturing OR
• Associate degree with 4 years’ experience in Life Sciences Manufacturing OR
• BA/BS with 2 years of experience in Life Sciences Manufacturing 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 Degree with 6 years’ experience in a Life Sciences Manufacturing environment OR
• BA/BS, preferably in Life Sciences/Engineering with 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

• Manufacturing Associate 2
• 2 Years of direct experience in a cGMP Manufacturing Environment
• BioWorks or BTEC Capstone cGMP coursework preferred
• Manufacturing Associate 3
• Qualified Experience on Unit Operation (DPFG Filler or Cell Culture – Seed Train)
• BioWorks or 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 and expertise of the operation of specific production equipment
• BioWork or BTEC Capstone cGMP Coursework Preferred
• Manufacturing Associate 5
• Proficient understanding of cGMP regulations and pharmaceutical industry standards
• BioWorks or 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

• Be exposed to an environment that may necessitate respiratory protection.
• Be exposed to noisy environments.
• Have a normal range of vision
• Climb ladders and stairs of various heights.
• Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours.
• Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required.
• May be required to lift up to 50 pounds on occasion.

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).