The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.
Job Description
What You’ll Do
During the project phase
Participate and support testing activities, such as FAT, PQ etc. as well as other related activitiesSupport and contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work InstructionsContribute to the preparation for operational readiness related to bulk drug product manufacturing Possible assignments include: Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes as well as testing and commissioning supportTravel up to 0-25% (international or domestic) may be required during the project phaseIn operations
Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and controlPerform operations of the Drug product filling lineExecute validation protocols according to cGMP Standard Operating Procedures (SOPs)Own the establishment of processes and trainings to become a trainer for coworkersMaintain compliance of GMP documents and ensure own training level is complaint and maintainedSupport and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor, as needed This role requires shift work (weekend and potential for nights)Perform other duties as assigned
Basic Requirements
High School Diploma or GED6+ years of direct experience in a manufacturing environmentPreferred Requirements
Associate’s Degree + 4 years of direct experience in a cGMP manufacturing environment ORBA/BS + 2 years of direct experience in a cGMP manufacturing environment Equivalent Military training or experience Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing)Understanding of manufacturing run cadence and order of shift activities Knowledge of cGMP, safety and operational proceduresA high degree of knowledge and expertise of the operation of specific production equipmentWORKING CONDITIONS & PHYSICAL REQUIREMENTS
Be exposed to an environment that may necessitate respiratory protectionBe exposed to noisy environmentsHave a normal range of visionClimb ladders and stairs of various heightsExperience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hoursUse hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is requiredMay be required to lift up to 50 pounds on occasion
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.
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