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Statistical Process Control (SPC), Quality Management Systems (QMS) - Change Control, Project Management, Lean Six Sigma, SOP/Batch Record Development, cGMP Regulatory Compliance, Process Development, Process Validation.
$50 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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As a Process Controls & Validation Engineer, a typical day might include the following:Working with a multi-functional team to support technology transfer and scale-up of processes from Regeneron’s process development teamAnalyzing R&D, late-stage characterization studies, and historical manufacturing data to support process control programs.
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Prior experience with control evaluation within model risk, operational risk, compliance risk, financial reporting, regulatory reporting, or internal audit is ideal. Identify the control activities performed by Model Validation and Governance team, and document the control activities in a formal control library.
$195,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Process Control Engineer will be responsible for maintaining instrumentation and control systems in support of plant production, quality, FDA, and safety goals. A fortune 500 company in the Chicago, Illinois area is looking to bring on a Hybrid Process Control Engineer.
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Related Terms: Embedded Controls Engineer, Embedded HITL, Embedded Software Development, Embedded Software Engineer, Embedded Systems Software Engineer, Embedded Verification and Validation Engineer, Embedded Test Engineer, Software QA, Software Quality Analyst, Software Validation Engineer, System and Performance Validation Engineer, System Test and Validation Engineer, Systems Validation Engineer, Validation Software Engineer, Verification Engineer.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Based in St. Gabriel, LA, the Process Control Engineer provides first-line process technical support to the plant operations’ control systems (DCS, PLC & SIS) to ensure safe and efficient operation.
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Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals. Lead pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, process optimization, and process validation activities related to solid oral dosage and parenteral drug products.
$118 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Execution of CSV protocols for associated commercial software systems including LIMS, MES and Master Control. 5+ years of validation experience in a cell and gene therapy GMP environment.
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The Process Control Engineer should have 5 years of recent experience working in a large industrial environment, preferably an integrated paper mill. The Process Control Engineer position reports to the Process Control Manager for the Arkansas Kraft Division.
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Process Control Engineer/Chemical Engineer/Electrical Engineer/Engineering/Process Controls/Chemicals/Mining/Petrochemicals/Paper Manufacturing/Controls Engineer/Chemical Manufacturing/Automation Engineer/Allen Bradley/Honeywell/PLC/DCS/Manufacturing.
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This individual will be responsible for interacting with analytical development, quality control, manufacturing, quality assurance and regulatory departments to enable the timely development and transfer processes of biologics drug substances to provide clinical materials for the company’s global clinical programs.
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0-3 years of Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems (Emerson DeltaV and/or Syncade experience is highly preferred.
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Responsible for delivering process control narrative documentation, assigning DCS and SIS I/O points, configuring regulatory controls, alarms, and HMI graphics on a DCS, and configuring logic in SIS.
$165,000 a yearFull-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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The ideal candidate will have a solid understanding of Anti-Money Laundering (AML) and Bank Secrecy Act (BSA) laws; regulatory consent order action plans and artifact validation; risk and control matrices; and design/operational effectiveness testing.
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Certified Anti-Money Laundering Specialists (CAMS), Certified Internal Auditor (CIA), Certified Information Systems Analyst (CISA), Certified Regulatory Compliance Manager (CRCM) or other relevant professional certification.
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validation engineer regulatory process control jobs Company: Philips Iberica Sau
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