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CSV Engineer
3 weeks ago
Smart Bot Systems Somerville, United StatesJob Description · Job Description · Hope you are doing well. · Please go through the job description. If you are fine, please share your updated resume. · Role: · CSV Engineer · Location: Raritan, NJ (Hybrid) · Type: Contract · Job Description: · Roles and Responsibilities · ...
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CSV Engineer
3 weeks ago
Novozen Healthcare LLC Raritan, United StatesRole: CSV Engineer · Location: Raritan, NJ · Roles and Responsibilities: · 7+ years of CSV experience with exposure in SAP ECC/S4 HANA system validation, Solman/ChaRM change control process, JIRA/XRAY/qTEST tools for validation required. · Working Knowledge of regulations: 21 C ...
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CSV Engineer
2 weeks ago
AppLab Systems Inc Raritan, United StatesHi, · Hope you are doing good... · I am Baiju represented to Applab Systems and I have an excellent job opportunity for you. Please find the below job description and if you are comfortable, please reply or contact me for further discussion. · Job Title: CSV Engineer · Location: ...
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CSV Engineer
4 weeks ago
Katalyst Healthcares & Life Sciences Raritan, NJ, United StatesResponsibilities: 3+ years' Experience in Validating MES or Manufacturing an Lab systems. Experienced in CSV activities in Manufacturing related applications like SAP Systems, MES systems or Lab related systems in the manufacturing space. Perform review for GxP systems to ensure ...
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CSV Engineer
4 weeks ago
eTeam Raritan, United StatesMinimum 7 years in CSV required. · Experience in Validation and Testing (UAT, Regression Testing) · Experience in leading application profile, operational requirements, business process and other project knowledge, as required, to provide the Services Experience creating detail ...
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CSV Engineer
1 week ago
Katalyst HealthCares & Life Sciences Raritan, United StatesResponsibilities: · 7+ years of experience in Computer System Validation. · Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and proced ...
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CSV Engineer
1 week ago
Advanced Accelerator Applications USA, Inc. Millburn, United StatesAdvanced Accelerator Applications USA Inc. has openings for CSV Engineer in Milburn, NJ: Develop, execute, review, and approve validation protocols and reports and coordinate CSV work execution with various departments and contractors. Execute and/or oversee work required to CSV ...
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CSV/QA Engineer
2 weeks ago
Xyntek, Inc Rahway, United States ContractAbout us · Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies ...
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CSV Engineer
5 days ago
Katalyst HealthCares & Life Sciences South Plainfield, United StatesKey Responsibilities: · Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. · This includes deliverables such as Planning (Project Validation ...
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CSV Engineer
1 week ago
Katalyst Healthcares and Life Sciences South Plainfield, United States*Role: This work will be full on-site in North Carolina. This Consultant will be working on Computer Systems, Building out CSV Protocols. Must have experience executing CSV protocols. 21 CFR Part 11 experience is needed. The type of Laboratory Systems are LIMS, SCADA, etc. Client ...
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CSV Engineer
4 weeks ago
Katalyst Healthcares & Life Sciences South Plainfield, United States OTHERRoles & Responsibilities: · Authors, executes and/or reviews validation documents such as validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA and validation exceptions/deviations for Computer and IT systems. · Expertise i ...
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Technical Equipment Specialist
1 week ago
Legend Biotech USA Somerville, United StatesJob Description · Legend Biotech is seeking a Technical Equipment Specialist as part of theTechnical Operations team based inRaritan, NJ. · Role Overview · The Technical Equipment Specialist will be responsible for ensuring equipment/systems required to support an expanding Cell ...
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Technical Equipment Specialist
1 week ago
Legend Biotech US Raritan, United StatesCompany Information · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ...
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Lead, Emerging Technologies
3 weeks ago
Johnson & Johnson Raritan, United StatesJohnson & Johnson is recruiting for a Lead, Emerging Technologies, Raritan, NJ or near a Johnson & Johnson office in India, Switzerland, Belgium, or the United States. This position may require up to 20% travel. · - Per our J&J Flex Policy, the expectation for this position is to ...
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Sr. Principal Engineer
5 days ago
Eli Lilly and Company Branchburg, United StatesEli Lilly and Company seeks a Sr. Principal Engineer to lead and implement site-wide engineering initiatives and projects. Effectively own and efficiently implement new systems, system upgrades, and system modifications. Lead roll out of engineering initiatives including Commissi ...
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Senior SAP Project Manager
1 week ago
firstPRO, Inc Princeton, United StatesfirstPRO is seeking a highly experienced Senior SAP Project Manager with 10-15 years of expertise in SAP implementation for our client located in North Jersey. The ideal candidate will possess excellent communication skills, the ability to work effectively with executives, and a ...
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Associate Director, Manufacturing Systems IT
3 weeks ago
Legend Biotech US Somerset, United StatesCompany InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including aut ...
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Project Lead
1 week ago
eTeam Inc Rahway, United States$60-65/Hour. · Familiarity on Commercial Off the Shelf Lab systems, · Windows Server environment, · Network experience. · Role Description: · Provide hands-on end user support, administration, installation, and issue resolution for GxP controlled laboratory equipment, servers, de ...
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Associate Director, Manufacturing Systems IT
3 weeks ago
Legend Biotech US Somerset, United StatesCompany Information · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ...
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Manager, Information Technology
2 weeks ago
Rocket Pharmaceuticals Cranbury, United States Regular Full timeOverview · Work at ROCKET PHARMA and help cure rare diseases · Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member pro ...
CSV Engineer - Raritan, United States - Novozen Healthcare LLC
Description
Role:
CSV Engineer
Location:
Raritan, NJ
Roles and Responsibilities:
7+ years of CSV experience with exposure in SAP ECC/S4 HANA system validation, Solman/ChaRM change control process, JIRA/XRAY/qTEST tools for validation required.
Understanding of quality risk-management concepts (ICH Q9) and adept in applying Good Manufacturing Practices principles
Experience in systems validation and quality frameworks and risk based quality approach
Perform quality review of relevant validation documentation pre and post execution for accuracy, completeness and ensures compliance with regulatory and client requirements.
Experience in executing change control and document managementKnowledge of GAMP5 and Quality Systems
Experience on decommission, Archiving and Data Integrity (ALOCA+)
Prior experience in using of tools like qtest, Document Management system (EDMS), ServiceNow and JIRA
Experience in computer systems validation, GXP regulatory knowledge with good documentation methods and CSA approaches and risk-based validation required.
Test automation tools and methods, authoring and/or reviewing validation deliverables such as Compliance Plan, Summary Report, Test Protocols, Test Scripts, Requirements and Trace Matrix is required.
Experience working in Agile methodology and tools is required.#J-18808-Ljbffr