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Lead Root Cause Analysis (RCA), Design of Experiments (DOE), Corrective and Preventative Action (CAPA), LEAN, and similar continuous improvement initiatives with a solution-focused mindset. This position leads various teams within FMI, directing quality personnel working with manufacturing and IVD operations teams within the Quality System Program, including manufacturing process review, batch release of products, IVD assay validation and verification, manufacturing material acceptance, device non-conformance and CAPA investigation.
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Lean Six Sigma Black Belt At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. Commercial Operations; Finance and financial modeling; Supply Chain Management and/or developing lean supply chains.
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Process Engineer Position Summary:Catalent Pharma Solutions is Chelsea, MA is hiring a Process Engineer who is responsible for assisting senior engineering staff in the design and implementation of manufacturing processes, instrumentation and equipment for clinical and commercial manufacturing.
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Demonstrate basic knowledge of the GXP cellular therapy product manufacturing, and program development and evaluation, as well as needs assessment and marketing of the programWorking knowledge of flow cytometry, molecular biology, and genetic engineering is a plus.
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Act as the key contact to SQF practitioner, OSHA and for all plant manufacturing practices & maintenance. Contact: John@SourceRecruitmentSolutions.com Our client, a premier Food Manufacturing Company with products sold nation wide is seeking an experienced Quality Assurance Manager.
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Director/Sr. Director - Process DevelopmentGreater Boston Area Competitive Compensation + excellent bonus/benefitsDuties and Responsibilities:Lead all process development activities (cell culture/banking/development, fermentation, protein purification, tech transfers)Oversee internal(in-house) and external vendors (domestic & international CDMOs)Work cross-functionally with CMC & Manufacturing leaders such as Analytical, Drug Product, QA/QC, Manufacturing, Supply Chain, etc.
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Provide process and technical leadership in the manufacturing process operations for Drug Substance, including but not limited to: Solution preparation, Adherent and suspension cell culture, Operation of Wave and disposable, single use Bio reactors, Chromatography and Tangential Flow Filtration & Viral Filtration.
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Tecogen Inc. has an immediate opening for a full time Engine Mechanical Assembly Technician located in Waltham, MA to work in our manufacturing facility. Manufacturing Technicians are provided will all necessary tools.
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Our core mechanical competencies span precision fabrication, diamond turning, EDM machining, additive manufacturing, and 5-axis machining. Requirements: 3 years of experience applicable experience required in both milling and turning subtractive manufacturing technologies (manual and CNC) Competency in reading a mechanical drawing and basic understanding of GD&T Ability to design and fabricate basic fixtures Experience using basic hand tools and inspection equipment, such as: Calipers, thread/pin gages, micrometers, dial indicator, etc.
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Serve as the Quality SME on the Chemistry, Manufacturing, and Controls (CMC) Governance teams covering Analytical Development, Process Development, Technical Operations, and Supply Chain topics for technical transfers, new product introduction, clinical trial and commercial products to assure a compliant strategy is developed, executed and maintained.
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Minimum of 5 years experience in developing, building, and testing complex electro-mechanical medical devices, design transfer, and process validation with broad knowledge of electrical, mechatronics, firmware, software, and systems engineering, including design verification testing, and transfer to manufacturing within a regulated medical device development environment.
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ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
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Tasks include involvement in digital, analog, and RF design projects from initial bill-of-material selection through Printed Circuit Board (PCB) manufacturing, Circuit Card Assembly (CCA), and subsystem assembly including resolution on all technical and supplier related issues.
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It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
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The ideal candidate will have a strong background in polymer chemistry and photopolymerization processes, with specific experience in formulating resins for additive manufacturing applications.
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lean manufacturing jobs Company: Dispensing Systems in Cambridge, MA
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