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Direct knowledge of design and troubles hooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
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Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.
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And familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation. Providing trouble shooting support to reduce production downtime.
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Oversee the operational functionality of the physical and electronic security systems, including access control systems, intrusion detection systems, CCTV, video management systems, visitor management programs, and electronic badging systems.
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In this role, the staff will be reporting into MCS Reliability Principal Engineer for guidance as well as interact with other F&E plant leaders for client feedback and support. Proficient in Spotfire/Tableau, SQL, Python, R as well as ability to develop advanced visualizations via R-shiny, Dash, or JavaScript technologies.
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Working in close coordination with technical teams and cross-functional stakeholders (e.g., Finance & Accounting, Procurement, Information Security), the IT Asset Manager establishes, enforces, monitors, and continuously improves asset management processes, standards, and controls.
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Providing strong process engineering/ technology transfer support of human therapeutic products in clinical development through commercial production. Purification/"downstream" laboratory (PD) or MFG experience with monoclonal antibodies, HR/EWC can look for keywords such as chromatography, filtration, UFDF, UF/DF, final fill, viral filtration, viral inactivation.
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Analyze survey reports, maps, drawings, blueprints, aerial photography, and other topographical or geologic data to plan projects. The applicant will join the engineering team responsible for designing industrial site development, pipeline improvement, renewable energy systems, and oil and gas facility projects.
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The Production Machinist performs semi-repetitive specialized machine operations. Description: Job Title: Production Machinist. This is a large modern production facility with many different positions available and opportunities to train and advance with the company.
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The Sr. Quality Mission Assurance Engineer will have either Customer Quality responsibilities or Product Quality responsibilities, in addition to the general responsibilities outlined, utilizing statistical methods to analyze production data to optimize the full production process and drive continuous improvement.
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Interact and coordinate with IC design team to validate and characterize new ROICs and ASICs against design specifications. Experience with liquid nitrogen and vacuum systems and components.
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Working knowledge of and exposure to phase appropriate quality systems, including deviations, CAPA, change control, and document management systems. Position Overview: We are seeking a highly experienced laboratory scientist with a strong conceptual understanding of and demonstrated expertise in analytical methods and Quality Assurance functions in the area of biotherapeutics to support the day-to-day operation of the process development and production labs.
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Coordinate regular management meetings to review corrective action and quality systems. Regal Rexnord PSI, a leading supplier in the Aerospace industry, is seeking a Quality Engineering Manager, who will be based at our Simi Valley, California manufacturing facility.
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Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.
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Proficiency in statistical analysis and experimental design, knowledge of laboratory and pharmaceutical production equipment including bioreactors, chromatography processes, ultrafiltration, diafiltration, sterile filtration, process tanks, and CIP/SIP systems.
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systems manager production policies analyze feedback coordinate formulate jobs in Moorpark, CA
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