Manufacturing Associate 1 - Upstream (Night Shift)

Position Overview The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility will be 24/7 operational and the role may require flexibility with working hours and shift rotation. Job Description Contributes to the preparation for operational readiness related to bulk drug substance manufacturing. Supports projects related to procedure review and creation, development or transfer of manufacturing processes, testing and commissioning support. May be required to travel up to 25% (international or domestic). Executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control. Performs in‑process testing (pH, conductivity, visual inspection). Executes validation protocols according to cGMP Standard Operating Procedures (SOPs). Maintains training to perform all required activities. Requires shift work (weekend and potential for nights). Performs other duties as assigned. Knowledge, Skills and Abilities Knowledge of the operation of support process equipment. Understanding of cGMPs, safety and operational procedures. Ability to perform operations and document them accurately. Ability to follow technical instructions and document them. Ability to work closely and effectively in a team environment. Strong verbal and written communication skills. Ability to adapt in a fast‑paced changing environment. Minimum Education and Experience Requirements High School Diploma or GED and 2 years of related experience. Preferred Education and Experience Associate degree, preferably in Life sciences or similar. 2 years or more of direct experience in a cGMP manufacturing environment. Qualified on a support area (e.g., Formulation Buffer Prep, Media Prep or DSM Buffer prep) after training. BioWorks or BTEC Capstone cGMP coursework preferred. Physical Demands and Working Environment 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 verbal 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 wrists, 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. 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 (View email address on click.appcast.io). #J-18808-Ljbffr FUJIFILM Holdings America Corporation