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PSG products are manufactured on three continents - North America, Europe, and Asia - in state-of-the-art facilities that practice lean manufacturing and are ISO-certified. Headquartered in Oakbrook Terrace, IL, USA, PSG is comprised of several world-class brands, including Abaque®, All-Flo™, Almatec®, Blackmer®, Ebsray®, em-tec®, Griswold®, Hydro™, Malema™, Mouvex®, Neptune®, PSG® Biotech, Quantex™, Quattroflow®, and Wilden.
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Awareness of External Regulations and Standards for Facilities & Corporate Security (PCI-DSS, NIST, ISO, OSHA, etc.) Awareness of External Regulations and Standards for Facilities & Corporate Security (PCI-DSS, NIST, ISO, OSHA, etc.
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Drive controls system hardware selection and implementation to create functionally safe systems capable of achieving SIL levels dictated by assessments as confirmed by SISTEMA. 5 Support the structuring, development, integration, and maintenance of a digitally integrated manufacturing facility included but not limited to SCADA, SDMS, LIMS, MES, BAS, QMS, data historians/storage, or other digital software solutions.
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The Equipment Cleaning Technician is responsible for performing all aspects of tank trailer and ISO cleaning, including inspecting the trailer for residual product, and post-cleaning inspection of the interior/exterior of the trailer.
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Proficient with the TrackWise QMS modules for Quality Events, CAPA, OOS, and Audit (or equivalent eQMS system). As a Quality System Manager in the pharmaceutical industry, your primary responsibility will be to develop and maintain an effective quality management system (QMS) to ensure compliance with pharmaceutical regulatory requirements and industry standards.
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Understand principles of Quality Management System, including requirements of Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), Quality System Regulation (QSR), United States Department of Agriculture (USDA), and International Organization for Standardization (ISO) 13485.
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Properly operate atmospheric testing equipment and understand the use and care of rescue equipment use in confined space rescue. Safely and effectively perform all duties to prepare, clean and inspect tank trailers and ISO's, including but not limited to: vents, valves, clean-out caps, clamps, loading/unloading lines, hoses, and other equipment that is to be cleaned as per normal tank cleaning procedures.
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Familiarity with CAD, preferably SolidWorks, static and dynamic FEA, generation of models & drawings. Create, modify and/or maintain complex design files (3D & 2D) using CAD to 3D model, analyze and document the product design preferably using Solidworks.
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Conduct information security risk assessments, including risk/issue intake/identification, triage and treatment plan preparation and tracking in accordance with our client Information Security and Compliance Frameworks as well as regulatory standards and requirements (i.e., SOX, PCI, ISO, SOC2, GDPR.
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Follow all company policies, cGMP, Food Safety, FDA, USDA, GFSI, FSMA, OHSA Safety regulations, QMS and SOP / SSOPs∯*∯ The QA Technician will support the implementation and enforcement of the Quality and Food Safety Management System requirements throughout all of the manufacturing process in order to ensure compliance with the company policies, FDA cGMP, and industry standards.
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Good understanding of Food Safety and Quality Systems (such as FSSC, AIB, ISO, GMP, GHP, HACCP) that are relevant to assigned area(s) of activity. Bachelor's degree in Food Science, Chemistry, Biology, Environmental Science or business degree with technical experience.
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What You'd Do: Position Summary: Director, Global Engineering: Reporting to the site General Manager, the Director of Global Engineering is responsible for development and implementation of engineering strategy for PSG Hydro brand globally.
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Manage programs, requirements, and matters involving patent, product liability, and intellectual property. Provides technical sales support as needed for special and customized products. Provides engineering expertise in the areas of tooling, prints, product specifications, product maintenance, raw materials and outside purchases throughout the organization.
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General Responsible for compliance of Quality System regarding ISO Standard 13485 alignment with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), FDA and other applicable requirements, laws, and standards.
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And requires the willingness and ability to cross train and work in multiple areas of the facility as needed It would be a plus if you also possess previous experience in: Experience working on high-performing teams in fast-paced environments Computer experience using Oracle and Microsoft applications a plus Prior experience in working in an FDA/ISO regulated environment.
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