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Performs ISO/cGMP appropriate quality tests for operations performed on all machines, maintains work area organization and documentation to satisfy ISO and GMP standards. The Lead Flexographic Printing Press Operator performs setup, testing, and cleaning of specialty pharma equipment.
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Experience operating any combination of manufacturing, converting, and finishing equipment (die cutting, laminating, slitting) You can always verify the validity of a job posting or recruiter interaction by contacting us at HRServiceCenter@zebra.com If you are a victim of identity theft contact your local police department.
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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods. The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing.
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Extensive knowledge of cGMP requirements and regulations for pharmaceutical manufacturing. Come work for the leader in reproductive medicine and maternal health! Minimum 5 years engineering experience in a pharmaceutical industry setting with a focus on aseptic processing and lyophilization.
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Immediate need for a talented Manufacturing Systems Validation Specialist. Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs.
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Title: Validation - Specialist, MSEO Manufacturing Systems Validation. The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle.
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Title: MSEO Manufacturing Systems Validation Specialist. Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment. The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant procedures, such as CSV SOP but no limited and applicable health authority regulations.
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The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant Client procedures, such as CSV SOP but no limited and applicable health authority regulations.
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General understanding of cGMP, ISO, FDA, MHRA, PMDA, USP, ATMP, PDA and EP regulations and guidelines as related to the manufactured of cell therapy products. At Bristol Myers Squibb we are reimagining the future of cell therapy.
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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR Part 11 electronic records and electronic signatures, and good documentation practices with the Client principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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Manufactures human blood-derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
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1+ years' relevant experience with materials management and/or supply planning within cGMP operations in matrixed organization with multi-level setup. Joining a team of highly qualified materials management and supply chain professionals, this individual will be responsible for supporting the supply chain management process, systems, and software functions for MRP, ERP, data sources, testing, integrations, reporting, analytics, and more within the cell therapy network.
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If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure.
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Jewelry, makeup, hair products, nail polish, nail extensions or other potential microbial sources are prohibited in cleanroom work areas. Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
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cgmp job in East Hanover, NJ
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