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Manufacturing Associate 5 Column Packing

FUJIFILM Holdings America Corporation

Position Overview Join a high‑growth biologics manufacturing team that’s bringing lifesaving therapies from concept to clinic. As a Senior Manufacturing Associate, you’ll lead day‑to‑day operations on a 24/7 manufacturing floor and play a hands‑on role in getting our new facility fully operational. If you love cGMP precision, coaching teammates, and solving problems on the fly, this is your next move. What you’ll do During the project phase, you will: Serve as a key contributor for operational readiness in bulk drug substance manufacturing. Support commissioning and qualification of equipment. Create and/or review procedures and SOPs. Help onboard manufacturing staff and transfer or develop manufacturing business processes. Support new item creation and single‑use assembly transfer or design. In routine operations, you will: Champion a strong safety culture and strictly follow EHS protocols. Lead, execute, and document manufacturing processing steps and support activities within your functional area, ensuring adherence to SOPs and cGMP regulations. Monitor and control processes, performing and/or overseeing in‑process testing (pH, conductivity, visual inspections). Execute validation protocols per cGMP SOPs and provide approvals as a backup to the supervisor. Maintain all required training and qualifications; train and mentor junior associates to elevate team capabilities. Support daily floor scheduling and act as a back‑up to the supervisor as needed. Lead troubleshooting for operational issues to restore steady‑state production. Assist the supervisor with shift huddles, tiered escalations, investigations, and continuous improvement projects. Serve as area lead for cycle counts and materials management. Perform other duties as assigned to meet production goals. What you bring Minimum education and experience (one of the following): High school diploma or GED with 8 years of experience in life sciences manufacturing, OR Associate degree with 6 years of experience in life sciences manufacturing, OR BA/BS, preferably in Life Sciences or Engineering, with 4 years of experience in life sciences manufacturing, OR Equivalent military experience. Plus: Proficient understanding of cGMP regulations and pharmaceutical industry standards. Fully qualified in a functional area (e.g., Drug Product Formulation and Filling, Weigh and Dispense, Cell Culture, or Purification) and subject‑matter expertise across all unit operations within that area (e.g., Inoculation, Seed Train, Production Bioreactor). Preferred Bioworks Certification. Why you’ll love it here Make a direct impact on patients by ensuring reliable, compliant manufacturing of critical therapies. Work with state‑of‑the‑art technologies and single‑use systems in a collaborative, safety‑first environment. Grow your leadership skills by mentoring others and acting as a back‑up to the supervisor. EEO Information 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. 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

Vacancy posted 5 days ago
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