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Job description
Job TitleThis role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.Job DescriptionDuring Project Phase:Key contributor in supporting the preparation for operational readiness related to bulk drug substance manufacturing.Supporting projects related to commissioning and qualification of equipment, procedure review and/or creation, support onboarding of manufacturing staff, development or Transfer 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:Adhere to strict safety protocols and contribute to culture of safety within the manufacturing environment. Lead, execute and document manufacturing 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.Oversee and/or perform in-process testing (pH, conductivity, visual inspection)Execute validation protocols. Provide approval as a backup to the supervisor.Maintain training to perform all required activities.Train and mentor junior manufacturing associates to enhance team capabilities.Support scheduling daily activities on the manufacturing floor and act as a back-up for the supervisor, as needed.Lead troubleshooting as required for operational issues.Assist 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.This role requires shift work (weekend and potential for nights).Who You AreYou have strong troubleshooting ability as well as verbal and written communication skills. You have the ability to adapt in a fast-paced changing environment, pivot and adjust plans accordingly. You have strong time-management skills and are able to think critically with superior problem-solving skills. You have a team-based attitude and the ability to work in a global team environment by building relationships while communicating effectively with others.Basic Requirements8 Years of experience in life sciences manufacturing with a High School Diploma or GED OR6 Years of experience in life sciences manufacturing with an Associate's Degree OR4 Years of experience in life sciences manufacturing with a Bachelor's Degree OREquivalent Military ExperiencePreferred RequirementsAssociate's DegreeBA/BS Degree, preferably in Life Sciences or EngineeringProficient understanding of cGMP regulations and pharmaceutical industry standardsFully qualified in a functional area (Ex: Drug Product Formulation and Filling, Weigh and Dispense, Cell Culture or Purification) while also acting as an SME on all unit operations within that functional area (i.e. Inoc, Seed Train and Production Bioreactor)BioWorks CertificationPhysical RequirementsPHYSICAL DEMANDSWill work in environment which may necessitate respiratory protectionMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.Ability to discern audible cuesWORKING ENVIRONMENTAbility 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 wrist, hands and/or fingers.Ability to conduct work that includes moving objects up to 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.ENVIRONMENTAL CONDITIONSWill work in heights greater than 4 feetEEO InformationFujifilm 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 InformationIf 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 ( ).
Worksite address
holly springs, NC, 27540, US
Who can apply
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