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Under direction of the Supervisor, the Manufacturing Associate will be responsible for job functions that support activities for manufacturing. The Associate is responsible for working on a shift with 3 – 8 peers with responsibilities of supporting implementation of new equipment, preparing filling and packaging materials, setting up the manufacturing line, sampling for QC testing, teardown and cleaning of equipment, managing raw material inventory, operating process equipment, visual inspection and packaging of drug product containers. In addition the manufacturing associate will be expected to operate in compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices. The position will require shift work and potentially include weekends, off hours, holidays, and overtime.
Understanding of process theory and operation of equipment including isolators, biological safety cabinets, automated filling/stoppering/capping machine, ultrasonic bath, autoclave, and filter integrity testers.
Ability to learn biopharmaceutical manufacturing processes including Aseptic Filling, Visual Inspection and Packaging, Sterile Filtration, Bio-process containers and Single Use Systems, and Lean manufacturing and 5S.
Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Support initiatives for implementation of new equipment and process optimization.
Identify and elevate processing issues and support solutions.
Gain experience with automation systems (LIMS, MES, PI, etc.).
Provide feedback and/or suggested changes to operational procedures.
Assist in the incorporation of new technologies, practices and standards into procedure.
Support trending of defined department metrics.
Crosstrain to support other manufacturing groups as needed.
Capable of writing and reviewing process documents.
Understanding of cGMPs as related to Manufacturing Operations.
Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
Ability to participate on projects and contribute to outcomes.
Capability to learn and support new business systems (TrackWise, ERP, etc.).
Specific vision abilities by this job include close vision, depth perception and ability to adjust focus
WORK ENVIRONMENT/PHYSICAL DEMANDS
• Consists of strenuous, repetitive work. The following list of physical movements maybe used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
• May require work around loud equipment.
• The use of personal protective equipment will be required.
• Requires various shift based work and off hours
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