FUJIFILM Cellular Dynamics, Inc · 3 days ago
Engineer 2 (Downstream)
US-NC-Holly Springs
Full-time
Onsite
Entry, Mid Level
2+ years expFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina, and they are seeking an Engineer 2 to provide technology transfer support and technical oversight during manufacturing operations. The role involves leading technology transfer activities, collaborating on sampling protocols, and providing training and technical support in a dynamic work environment.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Leads and supports technology transfer (TT) sub-team activities by conducting lab and pilot plant experiments
Collaborates and leads execution of sampling protocols, as directed
Participates in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs)
Supports training of manufacturing staff
Supports training members of the process sciences group on the use of equipment in the lab and pilot plant areas
Analyzes and summarizes lab data for clients
Writes process performance qualification (PPQ) protocols and reports
Supports and leads TT within unit operation, as directed
Interprets and communicates results to the TT team
Provides technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations
Writes reports and aids in closing out deviations
Provides process training and consultation on topics related to manufacturing and process
Provides input to technical risk assessments for new manufacturing processes
Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigations
Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
Supports continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
Manages lab equipment
Collaborates with colleagues to develop lab scale protocols
Executes and oversees sampling plans for lab runs
Serves as on-call for lab issues and concerns
Other duties, as assigned
Qualification
Required
Associate degree in Engineering, Life Science or Chemical Engineering with 4 years of related work experience (e.g., manufacturing); or
Bachelor's degree in Engineering, Life Science or Chemical Engineering with 2 years of related work experience (e.g., manufacturing); or Master's degree with no prior experience
Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)
Preferred
Experience working in a Good Manufacturing Practices (GMP) environment
Company
FUJIFILM Cellular Dynamics, Inc
Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.
51-200 employees
H1B Sponsorship
FUJIFILM Cellular Dynamics, Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (4)
2021 (1)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
Blake Anson
Senior Director - Discovery Research Partnering
Ilyas Singec
Chief Scientific Officer
Recent News
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