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Process validation practices (GMP), Risk analysis including use of FMEA. Technical Lead Engineer (Metals / Plastics) Deep understanding of metal, Plastic, and assembly manufacturing methods used for component manufacturing by either - stamping, machining (conventional CNC, mill turn, Electro chemical, Metal injection molding, powder metal, welding, mechanical joining, fine blanking, additive manufacturing (3-D printing), plastic injection molding, welding, joining, electro-mechanical, and others.
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Manufacturing Electronic Batch Record (EBR) generation using PAS-X (Korber)Validation of new Electronic Batch Records (Application Lifecycle Management)Assisting in implementation of new MES functionalityDevelop standard work and business practices for new MES functionalityContributing to Lean Transformation through recording NPI/EBR metrics and application of continuous improvement tools.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Secondary Loop Process Control Engineer provides technical leadership and automation support of manufacturing operations in accordance with appropriate Good Manufacturing Practices (GMP) and safety guidelines.
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Support and track deviations, investigations, and CAPA plans for the GMP Facilities Department Role will include conducting detailed investigations to determine root cause and necessary CAPAs by working cross-functionally with Facility Management, QA, Validation, and Business Area Management.
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Proactively implements recommended optimizations and adjustments of production facilities and equipment including self-reliant assurance of GMP compliance (change management, qualification, and validation activities.
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We are seeking an experienced Senior Validation Engineer to join our growing team. Senior Validation Engineer. Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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E.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. The Principal Quality Engineering Independently supports the most complex projects, collaborating with other quality, engineering, and manufacturing operations functions to ensure the quality aspects of validation and qualification activities, performing various types of analysis and generating and reviewing internal investigations, CAPAs, and change controls.
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Key Words: Field Service Engineer | HPLC | LCMS | MALDI | Prep LC | SFC | Maintenance | GMP | GLP | Service Schedules | Installation | Validation | Instrumentation | IQOQ | SAP | Troubleshooting.
ExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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The QA Engineer position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies. Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents.
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Working knowledge of Validation Lifecycle Approach (DQ, IQ, OQ, PQ, PV, and RQ) Knowledge of applicable US and worldwide regulatory requirements ( GMP, GDP, ICH) Ability to develop and/or review protocols using design documents and user requirements.
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We are currently seeking a Validation Engineer to be responsible for the qualification of various Analytical Laboratory Instruments & Software as well as, manufacturing equipment. VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries.
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Knowledge in CAPA, Nonconformance Technical Writing, Process & Software Validation, MES System. Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired. As a Quality Engineer you will ensure compliance to company/divisional policies and procedures and with FDA and ISO requirements by reviewing non-conformances, complaints, defect reports, and audit findings in order to coordinate corrective action.
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Actively ensures GMP quality, safety, environmental, and operating cost goals are achieved. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
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Experience in leading product/process support within a GMP setting: leading investigations, technology transfer, process monitoring, process validation, or routine clinical/commercial support is preferred.
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Responsible for the qualification of cleaning manufacturing equipment independently in aseptic filling and GMP areas, including autoclave, Vessel Equipment validation, Sterilization in Place of filling vessels and COP validation in accordance with corporate and departmental procedures.
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