21 cfr part 11 jobs in new jersey

Hybrid in Raritan, New Jersey

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4d ago

Role CSV Validation Lead Location -Raritan, NJ(Hybrid) Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or Global regulated environment with good understanding of GxP standa

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Contract

Depends on Experience

CMO Digital Liaison & Data Steward

Remote

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Yesterday

Business Analyst / Digital Steward CMO Connections Role Overview We are seeking a technically grounded Business Analyst / Digital Steward to support digital connections with external Contract Manufacturing Organizations (CMOs). This person will help own the digital engagement with external manufacturing partners end to end from partner onboarding and tech transfer through commercialization and long-term sustainment of inline products. The role operates across a matrixed portfolio of strategic CM

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Contract

Depends on Experience

Clinical Project Manager with RBQM, Veeva, CTMS, eTMF, EDC

Remote

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13d ago

Title: Clinical Project Manager with RBQM & Veeva Foster City, CA or Remote for people who can travel for meetings Experience Range: 10- max 22 years Writeup Skills PM with BA background and experience 6+ years of proven expertise in theclinical domain and operations, including hands-on experience with systems likeCTMS, eTMF, RBQM, and EDC. 8+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. 6+ years of

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Full-time

Depends on Experience

SAP QM Consultant (Life Sciences)

Hybrid in Jersey City, New Jersey

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28d ago

Required Skills: 14+ years of SAP QM experience Strong Life Sciences/Pharma/Biotech background SAP S/4HANA experience Expertise in Quality Inspection, Quality Notifications, Batch Management, and QM integration with MM/PP Knowledge of GxP, GMP, and FDA 21 CFR Part 11

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Full-time

Depends on Experience

CSV Consultant

Hybrid in Raritan, New Jersey

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21d ago

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards. Key Responsibilities: Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.Develop and execute validation documentation, including Valida

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Contract

45 - 50

CSV Engineer

New Jersey

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Today

Job Description: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer

Full-time

Mendix Platform Architect

Remote

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3d ago

Mendix Platform Developer/Architect|| Location Jacksonville, FL Remote || Employment type - contract Job Description: 10 years of software development experience. 5 years of Mendix development experience Experience serving as a solution architect or technical lead. Experience delivering enterprise-scale applications. Technical Skills Mendix Platform Architecture Mendix Studio Pro Microflows and Nanoflows Domain Modeling XPath and OQL Java Actions REST and SOAP APIS SQL Databases Azure

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Third Party, Contract

$65 - $70

Business Application & Systems Administrator

Remote or Boston, Massachusetts

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Today

Job Description The Business Applications & Systems Administrator is responsible for managing, implementing, and optimizing business applications. The role will develop & coordinate testing with impacted departments, including specifically coordinating with IT and Quality for validation & compliance. Manages business application projects, ensuring effective communication across teams/functions as well as informing management of progress and key issues. Key Responsibilities Application Managem

Full-time

USD 116,800.00 - 219,000.00 per year

Senior Director, Information Technology (BioPharma Industry)

Morristown, New Jersey

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Today

Description The Senior Director, Information Technology will lead enterprise technology strategy, infrastructure, cybersecurity, GxP validation, SOX compliance, and the business application roadmap for a growing late-stage clinical biopharmaceutical organization transitioning toward commercialization. This role will architect scalable technology capabilities, establish practical governance, and align IT with business objectives. The leader will manage a small internal IT team, oversee managed s

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Full-time

USD 210,000.00 - 255,000.00 per year

CSV Consultant(Computer System Validation ? GenAI, Agentic , SAP

Raritan, New Jersey

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Today

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Contract

USD45.0/HOURLY - USD52.0/HOURLY

Senior Infrastructure Engineer

Jersey City, New Jersey

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Today

Senior Infrastructure Engineer The Senior Infrastructure Engineer is a hands-on, technically strong engineer responsible for the day-to-day operation, administration, and continuous improvement of ANI's core IT infrastructure and end-user computing environment. The role spans enterprise networking, Microsoft 365 administration, endpoint and mobile device management, server administration (including backup and recovery), and meeting-room / audio-video technology. A key dimension of this rol

Full-time

USD 50.00 - 60.00 per hour

Senior PLM Windchill Solution Architect

Remote

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5d ago

Position OverviewWe are looking for aSenior PLM Windchill Solution Architectto lead a strategic, customer-facing PLM engagement for a leadingMedical Device / Life Sciences organization.The ideal candidate will be a senior techno-functional architect with strongPTC Windchill PLMexpertise and experience owning end-to-end architecture, technical governance, integrations, migration, validation, AMS, and customer stakeholder management.Key ResponsibilitiesLead end-to-endPTC Windchill PLM solution arc

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Contract

80 - 90

Senior Infrastructure Engineer

Hybrid in Princeton, New Jersey

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5d ago

Title: Senior Infrastructure Engineer Manager: IT Infrastructure & Operations Lead Location: Princeton, NJ Hybrid (on-site presence required for executive and AV support) About the Role The Senior Infrastructure Engineer is a hands-on, technically strong engineer responsible for the day-to-day operation, administration, and continuous improvement of ANI's core IT infrastructure and end-user computing environment. The role spans enterprise networking, Microsoft 365 administration, endpoint and mo

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Contract

$55 - $55

Equipment Engineer

Summit, New Jersey

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Today

Job Summary: The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment. The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal t

Full-time

WME Data Operations Lead – Salesforce Life Sciences Cloud | Pharma : Hybrid - East Brunswick, NJ

Hybrid in East Brunswick, New Jersey

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12d ago

WME Data Operations Lead Salesforce Life Sciences Cloud | Pharma | Patient Engagement :Hybrid - East Brunswick, NJ We are looking to hire a candidate with the skills sets mentioned and experience for one of our clients within the pharmaceutical Industry. This is a Hybrid position. Role Summary This role is critical to designing and implementing the operational controls, monitoring processes, reporting, and issue management framework required to effectively manageWME data operationsfollowing de

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Contract

Depends on Experience

Senior Technical Business Analyst

Remote

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6d ago

DescriptionJob Title: Senior Healthcare Business Analyst Type: Part Time Experience Level: Senior Seeking a highly skilled and experienced Senior Business Analyst responsible for bridging the gap between business objectives and technology solutions, ensuring that our projects align with organizational goals and deliver maximum value. You will utilize your expertise in business analysis and data-driven decision-making to identify opportunities for improvement and drive successful project outcomes

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Part-time

Depends on Experience

Salesforce Architect- Health Cloud and Pharma Domain

Remote

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Today

Salesforce Architect Health Cloud & Life Sciences Cloud (Pharma Patient Services Focus) Remote Job Summary We are looking for an experiencedSalesforce Technical/ Solution Architectwith deep expertise inSalesforce Health CloudandLife Sciences Cloudto lead the architecture and delivery of complex, compliant solutions for the Pharmaceuticals industry, with a primary focus onPatient Services(Patient Support Programs / PSP). The ideal candidate will design scalable, secure, and patient-centric arch

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Contract, Third Party

80 - 85

Sr SampleManager Implementation Engineer

Remote or Indiana

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior SampleManager LIMS Implementation Engineer How will you make an impact? As a Senior SampleManager LIMS Implementation Engineer, you will be a technical expert responsible for the configuration, implementation, integration, and deployment of Thermo Scientific SampleManager LIMS solutions. This role is highly hands-on and focused on translating defined laboratory processes and solution designs into robus

Full-time

USD 93,800.00 - 140,675.00 per year

Project Manager- Life science industry

Remote

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15d ago

Job Title: Project ManagerLife science industryLocation: Foster City, CA (Fully remote)Duration: FTEEducational Qualification*Any Bachelor''s DegreeExperience Range10 YearsTagline/Tech Stack Snapshot -PM with BA background and experienceRole Summary - (To be filled by Practice /DO)We are seeking a PM and Business Analyst with requirements gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating bu

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Full-time, Third Party

0 - 0

CSV Validation Lead

Hybrid in Raritan, New Jersey

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5d ago

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Contract

Depends on Experience

21 cfr part 11 jobs in New Jersey, USA