21 cfr part 11 jobs in raritan, nj

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

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

Remote

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12d 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

CMO Digital Liaison & Data Steward

Remote

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Today

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

CSV Consultant

Hybrid in Raritan, New Jersey

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20d 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 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

Hybrid in Princeton, New Jersey

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4d 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

Veeva Vault Regulatory Product Owner

Hybrid in Trenton, New Jersey

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4d ago

Job title: Veeva Vault Regulatory Product Owner Location: Ewing, NJ Work Arrangement: Hybrid Onsite 3 days a week Local Candidates: Required Job Summary We are seeking a Technical Product Owner to lead the strategy, roadmap, and delivery of digital solutions supporting Product Lifecycle Management (PLM), Quality Management Systems (QMS), and Regulatory processes across global R&D. This role combines product ownership with business analysis, partnering with stakeholders and technical t

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Contract, Third Party

Depends on Experience

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

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

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

CSV Validation Lead

Hybrid in Raritan, New Jersey

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5d ago

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Contract

Depends on Experience

CSV Lead

Hybrid in Raritan, New Jersey

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Today

About Us: CodeForce 360 is a trusted global IT talent partner helping Fortune 500 companies, system integrators, and enterprise organizations build high-performing technology teams. With over 16 years of industry expertise, we combine speed, precision, and market intelligence to deliver exceptional talent across today's most in-demand technologies. About the Job- We are looking for an experienced CSV Lead to join one of our enterprise client engagements. The ideal candidate should have st

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Contract, Third Party

$47 - $52

Lead Full Stack Developer

Hybrid in Princeton, New Jersey

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30+d ago

Lead Full Stack DeveloperAs part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference. We are seeking a

Full-time

140,000 - 175000

Staff Automation Engineer

Raritan, New Jersey

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Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 94,000.00 - 144,500.00 per year

Sr. Director, Data Science & AI, Orthopedics

Raritan, New Jersey

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Today

Full-time

USD 196,000.00 - 342,700.00 per year

Associate Director, Senior AI Engineer

Princeton, New Jersey

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Today

*NOTE: This is a Hybrid position based out of Princeton NJ* We are seeking a hands on Sr. AI Platform Engineer (Associate Director) to collaborate and drive platform aligned AI outcomes across the enterprise. The role provides engineering leadership and AI solution architecture oversight for platform and framework deliverables - reference patterns and guardrails, CI/CD & IaC blueprints, governance by design controls, observability, and cost/performance posture - delivered on approved platforms

Full-time

USD 169,222.00 - 253,000.00 per year

Senior Systems Analyst - Veeva/Vault CRM

Plainsboro Township, New Jersey

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Today

About the Department The Finance & Operations department brings insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance & Operations works closely across the organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our focus on innovation ensures we're c

Full-time

USD 120,300.00 - 222,600.00 per year

SAP BRH Functional / Support Lead

Remote

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Today

Job Summary: Seeking a Senior SAP Batch Release Hub (BRH) Functional/Support Lead with strong SAP BRH and S/4HANA QM expertise to support implementation, production sustainment, hyper care, and go-live activities in a regulated Life Sciences environment. Key Responsibilities Lead SAP BRH implementation, design, and production support. Handle P1/P2 incidents, RCA, defect resolution, integration troubleshooting, and hypercare. Support S/4HANA QM, including batch management, inspection lots, usage

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Contract

Depends on Experience

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

Senior Engineering/ IT Program Manager

Remote or Ponce, Ponce

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Today

Job Title: Senior Engineering/ IT Program Manager Client: Medical Device Manufacturing Company Duration: 12 Months Location: 100% Remote (Travel to Ponce, Puerto Rico as needed) Role Overview Lead large cross-functional engineering programs Support manufacturing, digital transformation, and regulated systems Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership Manage enterprise engineering programs Build roadmaps, milestones, and resource plans Deliver withi

Full-time

21 cfr part 11 jobs in Raritan, NJ, USA