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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.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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L’ensemble du corpus associé à chaque solution d’activation, selon les normes définies par leur cycle de vie (software development lifecycle – SDLC), avec le concours des différentes parties prenantes (locales et/ou régionales et/ou globales.
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Experience designing CI/CD pipelines and branching strategy for MuleSoft API Deployment within an Agile SDLC is a plus. Preferred candidates with MuleSoft Certificrations: Mulesoft Certified Platform Architect Mulesoft Certified Integration Architect.
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Ensure SDLC (System Development Life Cycle) and CSV (Computer System Validation) compliance according to our company guidelines, participating in regulatory audits of the site. Seasoned Expertise: 5-10 years of related IT and/or OT leadership experience in pharmaceutical manufacturing or a similar domain.
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Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods. Our client, a leading pharmaceutical company, is hiring a MSEO Manufacturing Systems Validation Specialist on a contract basis.
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Our Pharmaceuatical client is seeking a SDLC and GMP Documentation Specialist to join their team in West Point, PA. This individual will primarily support the BCMT Automation team supporting the GMP Biologics Pilot Plant.
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Our client, a leading Pharmaceutical company is hiring a MES Validation Specialist. 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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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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Solid understanding of software development lifecycle (SDLC) and Agile methodologies. MouthWatch is a privately held technology and software company servicing the dental healthcare industry, headquartered in Metuchen, NJ. Dedicated to improving overall health worldwide through innovative teledentistry software and intraoral imaging products, the company focuses on solutions that enhance care coordination, boost patient understanding, and facilitate the delivery of advanced dentistry.
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Title: Validation - Specialist, MSEO Manufacturing Systems Validation. 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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Java engineer with hands on development experience familiar with full SDLC exposure across design, build, unit test (not manual testing) and automation testing leveraging frameworks such as Selenium Web Driver.
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10+ year’s experience in a hands-on technical leadership/Integration Architect position. As the Integration Architect, you will design reusable assets, components, standards, frameworks, and processes to support and facilitate API and integration projects.
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Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. Experience in the qualification of cell therapy equipment a plus.
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Involve In All Phases Of Software Development Life Cycle (SDLC) Analysis, Design, Development Testing And Production Support With Agile (Scrum) Methodology. Providing Proper Branching Strategy, Enabling Continuous Integration And Continuous Deployment (CI/CD) For Deploying Applications Using Azure Devops.
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Advanced knowledge of pharmaceutical, manufacturing and laboratory systems. The Equipment Validation Engineer supports the successful implementation of laboratory equipment at multi-use sites through interaction with internal customers and external service providers.
Full-timeExpandApply NowActive JobUpdated 9 days ago
sdlc job in Rahway, NJ
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