21 CFR Part 11 jobs in New Jersey

Hybrid in Raritan, New Jersey

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Today

Role - Computer System Validation Engineer Location - Raritan, NJ(Hybrid) Job Details: 5-10 years experience in Computer System Validation of GxP systems Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation 5+ years of experience in validating SAP application implementation, test script review, test execution review, test defect management. Has working experience in any one or

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Contract, Third Party

$55 - $60

Clinical Data Engineer/Analyst

Remote

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5d ago

Qualifications: Bachelor s or Master s degree in Computer Science, Data Engineering, Life Sciences, or a related field.3+ years of experience in data engineering, preferably within clinical research, pharma, or healthcare domains.Strong experience with ETL/ELT tools, data integration, and data ingestion pipelines.Proficient in SQL, Python, and/or Scala for data engineering tasks.Experience with cloud-based platforms such as AWS, Azure, or Google Cloud Platform, and tools like Databricks, Snowfla

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Third Party, Contract

Depends on Experience

Validation Engineer

Raritan, New Jersey

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Today

Job Description: We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation skills. This role is critical in ensuring compliance, validation, and accurate documentation of enterprise applications, particularly in regulated environments (GxP/21 CFR Part 11). Responsibilities: Perform Computer System Validation (CSV) activities for SAP and OpenText systems. Develop and execute validation protocols (IQ, OQ, PQ

Full-time

Computer System Validation Engineer

New Jersey

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 3-7 years of experience in CSV within pharmaceutical, biotech, or medical device industries. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines. Experience with ERP, LIMS, MES, or other GxP systems. Extensive Experience in HPALM with Manual testing. Deep knowledge in Defect Management Life cycle. Proficient in writing validation protocols, reports, and SOPs

Full-time

Senior Clinical Data Manager

Remote

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20d ago

100% Remote Job Description Senior Clinical Data Manager Role Overview We are seeking an experienced Clinical Data Manager (CDM) to support multiple outsourced clinical studies. The ideal candidate will have strong hands-on expertise in EDC systems, data review activities, vendor data reconciliation, and CRO oversight. Responsibilities Manage 4 concurrent clinical studies outsourced to CROs, ensuring data integrity and compliance. Oversee day-to-day data review activities in the EDC, including

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Contract, Third Party

$50 - $90

Google Cloud Platform Auditor - IT SaaS

Remote

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20d ago

Education: Bachelor s degree in Life Sciences, Pharmacy, Chemistry, or a related field.Experience: Minimum 10+ years in Healthcare/Pharma QA, including 7+ years in Google Cloud Platform audit (preferably in SaaS platforms).Vendor Audits: Ability to assess third-party SaaS providers for compliance with contractual and regulatory obligations.Regulatory Knowledge: Strong expertise in ICH Google Cloud Platform E6, FDA, EMA, HIPAA, 21 CFR Part 11, and global standards. Experience working with clinica

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Contract

Depends on Experience

CSV Engineer

Raritan, New Jersey

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Today

Job Details: 5-10 years experience in Computer System Validation of SAP Application Implementation Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation 5+ years of experience in validating SAP application implementation, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like Servi

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Third Party, Contract

Depends on Experience

R&D Business Systems Lead (BSA/PM) with Life Sciences -GxP Expereince

Remote

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21d ago

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: R&D Business Systems Lead (BSA/PM) Location: Cambridge, MA (Remote) Duration: 12+ months Qualifications & Experience Required: 8+ years of combined experience in Life Sciences IT, including:Minimum 4 years in a GxP-regulated system administrator or support capacity.Minimum 4 years in project management, delivering cross-functional systems in R&D or Clinical domains.Str

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Contract

Depends on Experience

Clinical Data Engineer- "Clinical Research AND Pharma experience is Mandatory"

Remote

•

Today

We are seeking a skilled and motivated Clinical Data Engineer to join our data engineering team supporting clinical research and development initiatives. This role will focus on building and maintaining robust data pipelines to ingest, transform, and manage clinical trial and operational data across various sources and platforms. The ideal candidate has a strong background in data engineering within a life sciences, with experience supporting GxP or regulated data workflows. Qualifications: Bach

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Contract

$52 - $60

ServiceNow Admin

Remote

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4d ago

Experience Required: 7 10 years Position Overview We are looking for an experienced ServiceNow Developer with 7 10 years of proven expertise in managing, configuring, and optimizing ServiceNow platforms within the Life Sciences domain. The ideal candidate will have strong technical administration and development skills, experience in regulated environments (GxP, FDA 21 CFR Part 11), and the ability to align ITSM/ITIL processes with compliance and business objectives. Key Responsibilities Design,

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Contract

Depends on Experience

W2-Remote :: Senior QA Auditor / Computer System Validation (CSV) in Life Sciences Domain

Remote

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Today

Senior QA Auditor / Computer System Validation (CSV) in Life Sciences Domain 6-12 Months EST Zone (Remote) Position Overview: An accomplished Senior QA Auditor with a background in life sciences is required for a contract position that could extend from 6 months up to 12 months, with potential for permanent employment. This professional will play a vital role within a dynamic 18-person team, focusing on quality assurance and regulatory compliance across the US&C regions. The role entails perfor

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Full-time

Depends on Experience

Controls Engineer (DeltaV)

Remote

•

Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

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Full-time

USD 120,000.00 - 160,000.00 per year

SAP ABAP Developer

Remote or Boston, Massachusetts

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Today

Solution IT Inc. is looking for SAP ABAP Developer for one of its clients in Boston/Remote Job Title: SAP ABAP Developer Summary We are seeking an experienced SAP ABAP Developer to support and enhance SAP systems critical to our global medical device operations. This role will help deliver secure, compliant, and innovative SAP solutions aligned with business needs and SAP best practices, across manufacturing, quality, supply chain, and regulatory functions. The ideal candidate will bring techni

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Full-time, Third Party, Contract

SAP BTP Consultant

Remote

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7d ago

Job Role: SAP BTP Consultant Location: Memphis, TN Duration: 12+ months Role Description: Lead the design and delivery of enterprise integrations on SAP Business Technology Platform (BTP) with a primary focus on SAP Cloud Platform Integration (CPI/SAP Integration Suite).You will architect, implement, and govern integrations between SAP (S/4HANA/ERP/EWM/IBP/etc.), MOM/Manufacturing systems (e.g., Siemens Opcenter, Rockwell FactoryTalk), and ASRS/AGV ensuring secure, compliant, and highly availabl

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Contract, Third Party

Depends on Experience

Systems Administrator

Branchburg, New Jersey

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Today

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Full-time

USD 70,500.00 - 159,500.00 per year

Senior Commissioning, Qualification & Validation (CQV) Engineer

Remote or Athens, Georgia

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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

IBM Maximo EAM Specialist

Remote

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Today

Job Title: IBM Maximo EAM Specialist Job Location: RemoteDuration: 6+ months contract About Edify Headquartered in Naperville, IL, we are a dynamic team with over two decades of industry expertise, dedicated to delivering robust business solutions, staff augmentation, and a comprehensive range of application and web services. Recognized as one of Inc. Magazine's Fastest Growing Private Companies, we're committed to empowering businesses with innovative technology solutions. At Edify Technologies

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Contract

$55 - $60

Operational Technology (OT) Cyber Security Architect

Remote or Maryland

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Operational Technology (OT) Cyber Security Architect will serve as a senior authority driving the definition, composition, and implementation of security architectures across Thermo Fisher Scientific's manufacturing, laboratory, and R&D operations, as well as influencing the overall security of our enterprise corporate network. This role requires expertise in security principles and operations technology arch

Full-time

USD 143,000.00 - 190,600.00 per year

Software Quality Engineer

Secaucus, New Jersey

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Today

Job Description The Software Quality Engineer (SQE) within Quality and Regulatory organization plays a critical role in ensuring that software whether embedded in products, supporting clinical workflows, or used in enterprise quality systems meets rigorous internal quality standards and global regulatory requirements. The SQE is responsible for driving and executing software validation activities across the development lifecycle, contributing to design control, risk management, and audit readi

Full-time

Systems Administrator

Remote or Tennessee

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Today

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives

Full-time

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21 CFR Part 11 jobs in New Jersey, USA