21 CFR Part 11 jobs in New Jersey

Remote

•

10d ago

<>General SummaryThe Senior Validation Analyst leads strategic validation initiatives to introduce new GxP technologies at Southern Research. From technology assessment and procurement through planning, validation, operational support, and eventual retirement, this role owns validation deliverables and ensures systems remain in a validated state throughout their lifecycle. This position collaborates with the Business, Application Administrators, Information Technology, and internal Quality teams

Full-time

Depends on Experience

Sr. Business Analyst with Clinical Trails _ 10+ Years Experience

Remote

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4d ago

Position:1 Position- Business Analyst with Clinical Trails Location- Remote Job Description: The Business Analyst (BA) will serve as a key liaison between clients, product teams, clinical operations, and technical delivery teams. The BA will gather, analyze, and translate complex clinical trial requirements into functional specifications for eSource, DDC, and eCOA solutions. This role requires strong understanding of clinical trial processes, data capture workflows, regulatory expectations (Go

Easy Apply

Contract

Depends on Experience

BRH Technical Configuration Lead

New Jersey

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8d ago

Role: BRH Technical Configuration Lead Location: Raritan, NJ (Onsite) Full-time with Quantim Integrators (W2 Contract will work) The Batch Release Hub Technical Configuration Lead is responsible for the architecture, technical design, and hands-on configuration of the SAP S/4HANA-based Batch Release Hub (BRH) solution within the Johnson & Johnson enterprise SAP SAS (Serialization & Aggregation System) landscape. This role ensures the end-to-end technical integrity of batch disposition and re

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Full-time, Contract

LabVantage LIMS Engineer

Remote

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8d ago

Provide L2/L3 incident resolution for LIMS applications (LabVantage or LabWare). Diagnose and resolve configuration issues, workflow errors, sample lifecycle problems, and data inconsistencies. Conduct detailed root-cause analysis and implement permanent fixes. Maintain LIMS master data, workflows, templates, and stability modules. Support version upgrades, patches, and environment maintenance. Assist laboratory users with operational questions, access issues, and data troubleshooting. Support i

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Contract, Third Party

Depends on Experience

Scrum Master

New Brunswick, New Jersey

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22d ago

We are seeking an experienced Scrum Master to lead Agile delivery for mission-critical software development initiatives in the Pharmaceutical and Healthcare Lifesciences space. The ideal candidate will have hands-on experience working in regulated environments such as those governed by ISO 27001, ISO 27701, GDPR, FDA 21 CFR Part 11, and other compliance frameworks relevant to life sciences. You will serve as a key enabler in driving high-performance Agile teams, ensuring smooth delivery of softw

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Third Party, Contract

Depends on Experience

SAP EAM Project Manager

Remote

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5d ago

SAP EAM Project Manager Pharma Manufacturing Background Professional Summary A results-driven SAP EAM (Enterprise Asset Management) Project Manager with deep experience in pharmaceutical manufacturing environments. Adept at leading end-to-end EAM implementations, optimizing maintenance operations, and ensuring compliance with GMP, FDA 21 CFR Part 11, and global quality standards. Combines strong technical SAP expertise with hands-on understanding of plant operations, reliability engineering, an

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Contract

Depends on Experience

Integration Validation Lead

Remote

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4d ago

Job Title: Integration Validation Lead Location: Remote/WFH Duration: 9 months+ contract CSV / Validation Lead, with MES experience considered a strong plus. The ideal candidate will have 510 years of relevant experience. Computer Systems Validation (CSV) Lead Key Responsibilities: The selected candidate will support client engagement teams in delivering projects within the Life Sciences domain, including: Leading computer systems validation activities to ensure GxP regulated

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Contract, Third Party

$60 - $65

CSV Engineer

South Plainfield, New Jersey

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Today

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati

Full-time

Veeva RIM Security Consultant

Remote

•

Yesterday

Job Title:Veeva RIM Security Consultant Location: Remote Employment Type:Contract Duration: 4+Months About VLink:Started in 2006 and headquartered in Connecticut, VLink is one of the fastest growing digital technology services and consulting companies. Since its inception, our innovative team members have been solving the most complex business, and IT challenges of our global clients. Job Description: Requirement Details Experience Minimum 7 years of hands-on experience with Veeva RIM with exp

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Contract, Third Party

Depends on Experience

Veeva RIMS Security consultantAVEVA Controls Engineer

Remote

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Today

Job Description: The Veeva Regulatory Information Management (RIM) Security Consultant is a specialized expert responsible for designing, implementing, and maintaining the security architecture within Veeva RIM. This role ensures that access controls, security profiles, and permission sets align with regulatory compliance requirements, business needs, and organizational policies including distributor management frameworks and US DOJ (Department of Justice) restrictions. Key Responsibilities: "

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Full-time, Part-time, Contract, Third Party

Enterprise Solution Architect

Remote or Hybrid in Marvin, North Carolina

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Yesterday

Location: Charlotte, NC Hybrid 16-24 months Project The Enterprise Solution Architect partners across business units, technology leadership, and external stakeholders to design scalable, future-proof architectures that drive client's mission: enabling our customers to make the world healthier, cleaner, and safer. This role demands an architect who can walk into a boardroom as confidently as a design review bridging strategy, science, and systems thinking. You will be a trusted advisor to busine

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Contract

$60 - $70

Principal IT Salesforce Architect - Medical Communications

Remote or North Carolina

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Principal IT Salesforce Architect is a technology and architecture leader with broad knowledge of systems, services, software architectural concepts and system integration patterns. In this role, the Architect, is a member of the Clinical Research Group, aligned to the Medical Communications business unit. The Architect is responsible for understanding the business goals, requirements and objectives; and alig

Full-time

SAP QM Consultant with Life Sciences / Medical Devices Domain Experience

Hybrid in Raritan, New Jersey

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Yesterday

Title: SAP QM Business Process Owner / Functional Lead Medical Devices Location: Raritan, NJ (HYBRID MODE 3 DAYS A WEEK) Duration: 6+ months Job Summary We are seeking a senior SAP QM Business Process Owner (BPO) with deep expertise in the Medical Device / Life Sciences industry to drive global quality processes, governance, and digital transformation initiatives. This role will act as the bridge between Quality Business (QA) and IT, owning the end-to-end Quality Management process landscape in

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Third Party, Contract

Depends on Experience

Senior Manager - IT Business Partner Quality

Franklin Lakes, New Jersey

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Today

Job Description Summary The IT Business Partner - Quality serves as a key liaison between the Global Quality organization and IT, supporting the execution of approved business and technology strategies through effective delivery of technology solutions. Reporting to Technology and Global Services (TGS) leader, this role focuses on translating Quality business needs into well-defined IT initiatives, coordinating solution delivery, and ensuring alignment with BD enterprise standards, governance, a

Full-time

USD 143,300.00 - 236,500.00 per year

Associate Director, External Data Management

Remote or Warren, Ohio

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Today

The Associate Director, External Data Services, plays a critical leadership role, overseeing team members to ensure all activities align with Regeneron's procedures and industry best practices. This position collaborates closely with Clinical Data Management teams and External Data Vendors to deliver structured external data in compliance with Regeneron SOPs. The role also involves coaching, mentoring, and managing the performance of direct reports, while contributing to the department's strateg

Full-time

USD 157,200.00 - 256,600.00 per year

DIRECTOR OF TECHNOLOGY SOLUTIONS, DCRI

Remote or Durham, North Carolina

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Today

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,

Full-time

Sr. IT Engineering Manager, Salesforce & Vault - Foster City

Remote or Foster City, California

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Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 169,320.00 - 219,120.00 per year

Data integrity Specialist

Edison, New Jersey

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Today

Job Description: Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards (21 CFR Part 11, Annex 11). Review audit trails, monitor user access, and perform periodic data reviews. Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II), including root cause analysis, hypothesis testing, and CAPA implementation. Perform titration-based content uniformity tests as per SOPs and pharma

Full-time

Data integrity Specialist

Edison, New Jersey

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Today

Job Summary: The Data Integrity Specialist is responsible for implementing and maintaining data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards such as 21 CFR Part 11 and Annex 11. The role ensures compliance with GLP, GMP, and good documentation practices while supporting validated systems, audit readiness, and laboratory data accuracy. Roles & Responsibilities: Implement and maintain data integrity controls for HPLC s

Full-time

Director, ERP Boundary Systems Lead (Oracle Fusion)

Remote or Sleepy Hollow, New York

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Today

The Oracle Fusion ERP Boundary Systems Lead provides functional and technical oversight for key boundary applications supporting the Oracle Fusion Cloud modernization program-including but not limited to Icertis (Contract Lifecycle Management), Reval (Treasury), Zycus (iSource), Concur (Travel & Expenses), Serengeti, Pas-X MES, Kinaxis-APS, Veeva Vault, LIMS, Tracelink, Orchestrate, BlueMountain, Tririga, and Nemo (Contractor Management). The role ensures these systems align with future-state Or

Full-time

USD 183,100.00 - 305,200.00 per year

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21 CFR Part 11 jobs in New Jersey, USA