21 CFR Part 11 jobs in New Jersey

Manufacturing Data Strategy & Architecture Consultant

Remote

•

19d ago

Job title: Manufacturing Data Strategy & Architecture Consultant Location: Remote Position Overview Seeking a senior Manufacturing Data Strategy & Architecture Consultant to support the development of a future-state data vision, strategy, and architecture roadmap. The ideal candidate will bring deep expertise in pharmaceutical manufacturing data ecosystems, industrial data architectures, contextualization, semantics, and GxP-regulated environments. This role will serve as a trusted advisor to Pf

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Full-time, Third Party

Depends on Experience

SAP Validation

Remote

•

9d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

Sr Technical Writer

Remote

•

3d ago

Hi, Hope you are doing well. Job Title: Sr IT Technical Writer Location: Remote Duration:12+ Months Job Description: We areseeking a Senior IT Technical Writer with 10+ years of experience to support technical documentation initiatives within a Bio-Pharma/Life Sciences environment. The consultant will work closely with IT, engineering, application, infrastructure, quality, validation, and business teams to develop accurate and compliant documentation for regulated systems. The role involves cr

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Contract

Depends on Experience

GxP Deployment Lead – Kneat Gx

Hybrid in Raritan, New Jersey

•

7d ago

GxP Deployment Lead Kneat Gx Location: Lawrenceville, NJ Onsite Experience: 10+ Years Employment Type: W2 / C2C (as applicable) Position Summary: We are seeking an experienced GxP Deployment Lead with hands-on expertise in Kneat Gx to lead the implementation, configuration, validation, and rollout of paperless validation and digital execution processes within a regulated life sciences environment.The ideal candidate will act as a bridge between Business, Quality, IT, and Validation teams, ensu

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Third Party, Contract

60 - 65

Data Architect

Hybrid in Edison, New Jersey

•

Yesterday

RAYVEN IT Solutions is a leading IT Consulting firm offers a comprehensive range of services that are domain specific with a strong focus on technology, business process & practices. Founded by top-notch profs with the vision of bridging the gap between people, process & technology. RAYVEN has the capability & resources to help clients realize their technology driven business transformation initiatives. We are specialized & provide solution-based services to our clients in the areas of SAP/ERP.W

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Contract, Third Party

Depends on Experience

Product Owner

Remote

•

3d ago

Iris's direct client, a leader in Healthcare services, looking to hire a strong Product Owner for a Long-Term Contractual role Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, Clinical Trial Platform Job Description: Product Manager Clinical Trial Platform Role Overview The Product Manager for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end-to-end clinical trial executio

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Contract

Depends on Experience

Senior Consultant - GxP & Clinical Quality Assurance

Remote

•

24d ago

Arthur Lawrence is looking for a Senior Consultant - GxP & Clinical Quality Assurance one our clients project based on Remote. Please find the job description below and send us your updated resume if interested: Must-Have Skills:10+ years of GxP Quality Assurance experience in biopharma, biotech, or medical devices, including 3+ years at Senior Manager or Director level. Hands-on expertise in Google Cloud Platform site audits, CRO governance, TMF management, and FDA BIMO inspections. Strong ex

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Contract, Third Party

$70 - $75

ServiceNow Technical Architect

Franklin Township, New Jersey

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2d ago

Job Title: ServiceNow Technical Architect Location: Somerset, NJ-onsite Duration: 12+ Months Rate: DOE Job Description Experience as a Senior Technical Lead / Architect / Consultant Experienced in ITIL Process Definition, Integration Solutions, Architecture level configurations. Experienced in leading at least 3 or more Transformation Implementation projects in ITSM /ITOM /ITAM / Integrations area and complete Implementation lifecycle for ServiceNow. Experience in ServiceNow custom applicati

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Contract

Depends on Experience

Technical Architect

New Jersey

•

Today

Job Title : Technical Architect - ServiceNow Location : Somerset, NJ Client: TCS Rate: $55/hr on W2 $60/hr on C2C Positions: 3 JD : PLEASE NOTE The rates may be negotiable based on experience, education, geographic location, and other factors.. Technical Architect - ServiceNow Experience as a Senior Technical Lead / Architect / Consultant Experienced in ITIL Process Definition, Integration Solutions, Architecture level configurations. Experienced in leading at least 3 or more Transformation

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

SENIOR PRODUCT OWNER

Remote

•

Today

Hi, Greetings from Iflowsoft Solutions Inc Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, with Clinical Trial Platform experience-- MUST Job Description: Product Manager Clinical Trial Platform Required Qualifications Bachelors degree in life sciences, engineering, product management, or related field. 12+ years of product management experience, ideally within clinical trials, healthcare technology, or regulated SaaS platforms. Strong understanding of

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Full-time

Depends on Experience

Manual QA with Healthcare Experience

Remote

•

2d ago

Title -Manual QAwith Healthcare Experience Location:Dallas, TX (Hybrid - Onsite) Work Type: W2/C2C/1099 Contract Experience: 5 Years of experience candidate Job Description:We are looking for a SeniorQAEngineer with deep expertise in healthcare processes and AI driven applications. This role is critical in ensuring the safety, accuracy, and compliance of our healthcare-focused AI products. The ideal candidate will have a strong background inQAmethodologies (bothmanualand automatedtesting, buildi

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Contract, Third Party

32 - 36

Equipment Engineer

Summit, New Jersey

•

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 and Validation Engineer

New Jersey

•

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 s

Full-time

Data Engineering Manager & Architect (Hybrid Leadership/Architect Role)

Hybrid in Raritan, New Jersey

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9d ago

Job Title: Data Engineering Manager & Architect (Hybrid Leadership/Architect Role) Experience Required: 15+ Years Time Zone Coverage: Eastern Time (ET) - required overlap with client leadership and onshore/offshore teams Domain: Life Sciences (Highly Regulated Environment) Cloud/Platform: Microsoft Azure, Databricks About the Role We are seeking a seasoned Data Engineering Manager/Architect to lead complex data migration and data engineering initiatives within a highly regulated life sciences en

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Contract, Third Party

80 - 90

Sr SampleManager Implementation Engineer

Remote or Indiana

•

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

Planisware PPM Administrator w/ Power BI

Remote

•

Today

Systems / Data Analyst Location: Remote (Easter Time Zone) Contract Duration: 12 Months plus Start Date: ASAP About the Role Our client is seeking an experienced Systems / Data Analyst to support its Technical Services organization within the pharmaceutical and life sciences industry. This position will serve as the primary Planisware System Administrator, with responsibility for platform configuration, governance, user access, and ongoing enhancements. The Systems / Data Analyst will also d

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Contract

GxP Systems and Support Administrator

Remote

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Solutions Engineer, Life Sciences

Remote

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27d ago

Who we are At Domino, we build software that helps the largest, AI-driven organizations build and operate advanced data science and AI solutions at scale. Our platform integrates a streamlined model development environment, MLOps capabilities, and novel features for collaboration, reuse, and reproducibility - all of which make data science teams more productive, reduce time to value, and ensure compliance. Our customers - like Johnson & Johnson, GSK, Bristol Myers, UBS, FINRA and the US Navy -

Full-time

USD 160,000.00 - 230,000.00 per year

Manager, IT Assurance and Compliance-Quality Systems

Remote

•

Today

Job Description Position Summary The Manager, IT Assurance and Compliance - Quality Systems is responsible for leading and managing the IT Quality Compliance program, ensuring alignment with corporate and site quality and compliance initiatives. This role oversees the establishment, maintenance, and continuous improvement of global IT assurance and compliance processes, including computer software assurance (CSA), software quality management (SQM), and regulatory compliance (GxP, SOX, and other

Full-time

Platform Information Security Officer (PISO), Life Sciences Platform

Remote

•

Today

Bring more to life. At Danaher, our work saves lives. And each of us plays a part. Fueled by our culture of continuous improvement, we turn ideas into impact - innovating at the speed of life. Our 60,000+ associates work across the globe at more than 15 unique businesses within life sciences, diagnostics, and biotechnology. Are you ready to accelerate your potential and make a real difference? At Danaher, you can build an incredible career at a leading science and technology company, where we

Full-time

USD 225,000.00 - 275,000.00 per year

21 CFR Part 11 jobs in New Jersey, USA