21 CFR Part 11 jobs in New Jersey

Branchburg, New Jersey

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Today

Responsibilities: Process and Cleaning Validation Experience. Equipment Qualification (IOQ/PQ). Quality System Experience (Veeva, Track wise, Compliance Wire). Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years. Statistical Analysis (Minitab or JUMP). The Process/Validation Engineer is responsible for providing engineering production support including: Implementing process and technology improvements. Process and Cleaning Validation. Equipment Qualifica

Full-time

Engineer Process Support II

Somerville, New Jersey

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Today

Responsibilities: Implementing process and technology improvements. Process and Cleaning Validation. Equipment Qualification. Collecting, monitoring, analysing, troubleshooting, and reporting manufacturing data related to performance in the areas of quality, cost, and speed/service to market. Investigating non-conformances, CAPAs, process performance drifts and implementing corrective and preventative actions. Responsible for the initiation and follow-through of the change control processe

Full-time

CSA Auditor, TraceLink

Remote

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23d ago

We are seeking a Computerized System Assurance (CSA) Auditor with deep experience in TraceLink and GxP-regulated environments to ensure the compliance, validation, and lifecycle integrity of computerized systems supporting serialization, traceability, and supply chain management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory expectations for data integrity and system validation. Key Responsibilities: Plan, conduct, and report CSA aud

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Contract

85 - 90

Computer System Validation Engineer

Princeton, New Jersey

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Today

Job Description Summary: The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality Assurance, and business stakeholders to validate new and existing systems, document validation evidence, and support audits and inspections. Roles & responsibility: Knowledge on FDA Guidance's and industry Standards Develop and execute validation plan

Full-time

Kneat System Developer (Technical & Validation Focus)

Remote or Parsippany-Troy Hills, New Jersey

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Today

Job Title: Kneat System Developer (Technical & Validation Focus) Location Remote/WFH Duration: 6 months+ contract Note: Need strong Kneat Development / Configuration and not a user of Kneat. Overview of the Project: You will be configuring Kneat workflows and interacting with business stakeholders. Key Responsibilities: Develop, configure, and maintain Kneat GxP Validation software. Create and manage disciplines and templates. Ensure system validation and compliance with GxP, 21 CFR Part 11,

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Contract, Third Party

Validation Engineer

New Brunswick, New Jersey

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Today

Job Description: Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international guidelines (like 21 CFR Part 11 and Annex 11), and company standards by validating their functionality throughout their lifecycle. Key responsibilities include developing and reviewing validation documentation (protocols, reports), performing risk and impact assessments, coordinating

Full-time

Veeva Migration Consultant

Remote

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12d ago

We have a below position for Veeva Migration expert for remote work, please find the JD below and let me know your interest. Title: Veeva Migration Consultant Exp: 7+ to 10 years of experience in Veeva migration and implementation activities Duration: 6-12 Months Responsibilities: Migration Work stream Lead-Veeva RIMS Implementation Key Responsibilities Migration Strategy & PlanningDefine migration scope, timelines, resources, and success metrics.Develop detailed migration plans and risk mitiga

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Contract, Third Party

Depends on Experience

Project Manager Regulated Systems (Veeva Implementation)

Remote

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Today

Job Title: Project Manager Regulated Systems (Veeva Implementation) Position Summary We are seeking an experienced Project Manager with a strong background in regulated systems and vendor/IT coordination to lead the implementation and enhancement of Veeva applications (Vault QMS, RIM, QualityDocs, etc.). The ideal candidate will have demonstrated success managing projects in GxP-regulated environments, ensuring compliance, alignment with business objectives, and timely delivery of system soluti

Contract, Third Party

Veeva Techno-Functional Lead Life Sciences

Remote

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Today

Job Title - VeevaTechno Functional Lead- Presales Remote 6 months contract to hire. Travel to Client sites as needed(expenses paid) Must currently live in WEST, mountain or CENTRAL time zone Key Responsibilities: Solution Design & Delivery Lead end-to-end implementation of Veeva CRM and Vault modules (PromoMats, MedComms, Align, Network, etc.). Translate business requirements into scalable Veeva solutions, ensuring compliance with GxP and regulatory standards. Oversee configuration, customiza

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Contract

Depends on Experience

Statistical Software Configuration Specialist (Statistica TIBCO)

Remote or Hybrid in Vacaville, California

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Today

Statistical Software Configuration Specialist (Statistica TIBCO) Vacaville, CA / A hybrid model (once or twice in the office) / Remote Duration: - 6-12 Months+ For a "Statistica Software configuration specialist" role, which likely involves both data analytics and potentially on-site manufacturing support or collaboration, a hybrid model (once or twice in the office) is a probable arrangement. Statistical Software Configuration Specialist (Statistica TIBCO) Position Overview The Statistical Soft

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Contract, Third Party

Depends on Experience

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Senior Medidata Consultant / Developer (EDC & Coder)

New Brunswick, New Jersey

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Today

Job Title: Senior Medidata Consultant / Developer (EDC & Coder) Location : New Brunswick, NJ Experience Level: 6 10 years Employment Type: Full-Time / Contract Position Overview We are seeking a Senior Medidata Consultant / Developer with extensive experience in Medidata EDC (Rave) and Medidata Coder platforms to support, enhance, and optimize clinical trial data management systems. The ideal candidate will possess a strong understanding of clinical data workflows, along with solid

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

Director - Lab Informatics

Remote

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Today

Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory complianc

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Contract, Third Party

Director, Lab Informatics

Remote

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Today

Director, Lab Informatics Job Location- Remote Long Term Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, incre

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

Senior Validation Engineer / Lead

Remote or Durham, North Carolina

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Today

Job Description Summary The Senior Validation Engineer is a subject matter expert in the Commissioning and Qualification program and provides leadership and mentorship in the qualification of equipment, utilities, and processes. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is a

Full-time

USD 103,600.00 - 192,400.00 per year

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Global Maximo (OMX/MAS) Technical Lead and Administrator

Remote or Hybrid in Pittsburgh, Pennsylvania

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Today

NTT DATA Services currently seeks a Global Maximo (OMX/MAS) Technical Lead & Administrator Project Overview Provide a comprehensive technical and security matrix as part of the new site implementation. This initiative includes conducting site-level settings workshops, delivering OMX orientation sessions for preventive maintenance and calibration for both GMP and non-GMP assets, and ensuring the new site fully adopts and aligns with existing OMX global policies and procedures. The selected consu

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Contract

BASED ON EXPERIENCE

GenAI Engineer

Piscataway, New Jersey

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Today

Pozent is a rapidly growing company focused on delivering next-generation digital, data, and AI-driven solutions to global clients and achieve measurable business outcomes. Our team is geared towards innovation and thrives where talent meets opportunity. We work on Generative AI, Cloud, Data Engineering, Automation, and Full-Stack Development, delivering impactful projects.Why join us: Exciting Global Projects and career growth: Work directly with top clients and cutting-edge technologies provi

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Full-time

BASED ON EXPERIENCE

Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing)

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 126,820.00 - 164,120.00 per year

Cyber Security Engineer

Remote

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Today

Job Description Summary The Caption Health SBU focuses on clinical applications that aid in early disease detection, using AI to assist in conducting ultrasound scans. The Product Security Leader PSR is part of our security team and helps safeguard the integrity, confidentiality, and availability of our healthcare technology products. This role is ideal for an experienced product security analyst who is passionate about building secure, compliant, and resilient systems in a regulated environment

Full-time

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21 CFR Part 11 jobs in New Jersey, USA