**Position Overview** This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This position will ensure drugproduct manufacturing start up phase is supported from a knowledge standpoint and will then help the supervisor lead the manufacturing effort afterstart up phase. **Job Description** **What You’ll Do** _During Project Phase:_ • Key contributor in supporting the preparation for operational readiness related to drug product manufacturing. • Supports projects related to: Commissioning and qualification of equipment, procedure review and/or creation, support onboarding of manufacturing staff, development orTransfer of Manufacturing business processes, new item creation, or single-use assembly transfer or design. • 0-25% travel (international and/or domestic) may be required. _In Operations:_ • Adheres to strict safety protocols and contribute to culture of safety within the manufacturing environment. Leads, executes and documentsmanufacturing processing steps and/or manufacturing support activities, process monitoring and control within a functional area, ensuring compliance with Standard operating procedures (SOPs) and cGMP regulations. • Oversees and/or performs in-process testing (pH, conductivity, visual inspection) • Executes validation protocols according to cGMP Standard Operating Procedures (SOPs). Provides approval as a backup to the supervisor. • Maintains training to perform all required activities. • Trains and mentors manufacturing associates to enhance team capabilities. • Supports scheduling daily activities on the manufacturing floor and act as a back-up for the supervisor, as needed. • Leads troubleshooting as required for operational issues. • Assists the supervisor with shift huddles and tier escalations, investigation, and continuous improvement (CI) projects, as needed. • Area lead for cycle counts and materials management • Other duties as assigned. • After start-up phase this role requires shift work (weekend and potential for nights) **Basic Requirements** + High school diploma or GED with 8 years’ experience in life sciencesmanufacturing **OR** + Associate degree with 6 years’ experience in life sciencesmanufacturing **OR** + BA/BS, preferably in Life sciences or Engineering 4 years ofexperience in life sciences manufacturing **OR** + Equivalent Military experience **Preferred Requirements** + Proficient understanding of cGMP regulations and pharmaceutical industry standards. + Fully Qualified in a functional area (ex. Drug Product Formulation andFilling, Weigh and Dispense or Cell Culture or Purification). + Bioworks Certification **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** + Will work in environment which may necessitate respiratory protection + May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program + Ability to discern audible cues. + Ability to ascend or descend ladders, scaffolding, ramps, etc + 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 writs, hands and/or fingers + Ability to conduct work that includes moving objects up to 33 pounds + Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. + 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._ **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). **Job Locations** _US-NC-Holly Springs_ **Posted Date** _6 days ago_ _(7/28/2025 10:05 AM)_ **_Requisition ID_** _2025-35213_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_