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TheLine Mechanicis responsible for the production equipment, production projects (assigned by management), follow maintenance programs of the Personal Care in the Production Area, which includes all Line equipment (Fillers, labelers, Cappers, Torquers, pluggers, Tubers, check weighers, cartoners, pumps, conveyors, Ink-Jet printers), and all packaging related equipment.
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Sr. Manufacturing Equipment Maintenance Technician will problem solve, repair, and perform preventative maintenance on GMP packaging and serialization equipment. Maintain equipment files and document maintenance activities in compliance of SOPs and Good Manufacturing Procedures (cGMP.
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Equipment Maintenance and Repair:Conduct routine inspections, preventive maintenance, and repairs on pharmaceutical manufacturing equipment, including but not limited to mixing machines, compression machines, encapsulation machines, coating machines, and packaging machines.
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Leads Clinical Packer Technicians by operating a variety of packaging machinery; assisting in the set-up/changeover of packaging machinery or equipment by using layout schematic; leading rework efforts; and interpreting statistical process control charts.
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Perform decommissioning activities and final reports for equipment, systems, utilities, facilities and/or manufacturing/packaging process for pharmaceutical, biotech and medical devices industries in accordance with cGMP requirements.
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Tasks for this role are likely to include but not limited to: Updating and or formatting cGMP procedures, methods, specifications, work instructions, job aids, training instructions, and protocols, manufacturing and packaging batch records into the document management system or other process.
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Quality Assurance responsibilities include, but are not limited to, cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production and process controls.
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Maintain outgoing packaging quality levels and assures compliance of cGMP's. Sign-off that the packaging line was properly prepared by initialing and dating the Equipment Use and Cleaning Log.
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To have packaging lines running the highest quality product in the most effective, safest and productive manner by also ensuring compliance with the Quality Systems. Comply with all Standard Operating Procedures (SOPs) and current Good Manufacturing Process (cGMP.
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Founded in 2014, our company has rapidly expanded from a Research and development entity to a fully functional cGMP facility that can support product development, analytical testing, product registration, and commercial manufacturing and packaging of high-quality drug products.
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Position SummaryThe Head of Quality Management USA is the overall Quality responsible of our Healthcare Solutions sites in Middletown, DE and Pennsauken, NJ. Within those facilities, Datwyler produces rubber and aluminum parenteral drug packaging components.
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Troubleshooting of packaging equipment problems associated with die cutting/punching of transdermal patches, web alignment, pick & place, cartoning and other packaging and labeling equipment components.
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This person will support activities within Warehouse operations, including goods receipt, sampling, and outbound shipping process as well as perform incoming inspections including ID testing, sampling of raw materials/GMP supplies (components, printed packaging materials, etc.
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Previous experience with combination products, device assembly, pharmaceutical packaging, and filling in aseptic environment. 7+ years demonstrated ability in a GMP FDA, cGMP, ISO, or other regulated production environments.
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This position is responsible for performing operations related to the manufacturing and/or packaging of pharmaceutical products through equipment set-up, operation, clean-up and maintenance in compliance with all regulatory cGMP requirements and company policies and procedures.
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