21 CFR Part 11 jobs in New Jersey

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

Process/Validation Engineer

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

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,

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 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

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

CSV Engineer

Raritan, New Jersey

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Today

Roles & Responsibilities: 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 two of the following domains Tool validation like Servic

Full-time

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

Remote

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15d 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

Easy Apply

Contract

Depends on Experience

Remote-Sr Business Analyst with Lifesciences client - CRM experience

Remote

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Today

Location: - Remote work but client would prefer candidates from New Jersey.Candidates should be authorized to work in the United States. Educational Qualifications: - Engineering Degree BE/ME/BTech/MTech/BSc/MSc.Technical certification in multiple technologies is desirable. The Senior Business Analyst Pharmaceutical is a pivotal client-facing role responsible for driving business transformation initiatives within leading pharmaceutical companies. This position requires deep expertise in FDA reg

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Contract, Third Party

Depends on Experience

Sr Business Analyst - CRM experience, LifeScience -Remote

Remote or Hybrid

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Today

Role: Sr Business Analyst - CRM experience Location: REMOTE (client would prefer candidates from New Jersey) The Senior Business Analyst Pharmaceutical is a pivotal client-facing role responsible for driving business transformation initiatives within leading pharmaceutical companies. This position requires deep expertise in FDA regulations, including 21 CFR Part 11, PDMA, and the Sunshine Act, and a comprehensive understanding of US pharmaceutical sales and market data. The successful candidat

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Third Party, Contract

$Depends on Experience

SDMS Validation Engineer

Remote

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27d ago

Role: Scientific Data Management System (SDMS) Validation Engineer Location: NEAR SHORE - South America/Canada Length: Long term rolling contract CSV engineers and for the applications: Discoverant, BIOVIA ELN, SDMS, Empower, LabX, SoftMax Pro. Job Description: Job Overview: The SDMS (Scientific Data Management System) Validation Engineer is responsible for the qualification, validation, and compliance of scientific data management systems within laboratory environments, particularly in regula

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Contract

$30 - $35

Commercialization & Validation Engineer

Remote or Hybrid

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Today

The CSA Validation SME is a key stakeholder within the ELC CSA Center of Excellence (COE). This role ensures the integrity of CSA projects with a strong focus on risk assessment, compliance, and regulatory adherence. Acting as a subject matter expert (SME), the CSA Validation SME serves as a bridge between COE leadership, protocol authors, and testers. The SME will ensure projects meet regulatory, data integrity, and organizational (R&D/GSC/IT) policies while maintaining best practices in valida

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Contract

$70 - $75 per hour

Controls Engineer (DeltaV)

Remote

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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

Biovia ELN System Administrator

Remote

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27d ago

Role: Biovia ELN System Administrator Location: NEAR SHORE - South America/Canada Length: Long term rolling contract Job Description: The BIOVIA ELN (Electronic Laboratory Notebook) System Administrator is responsible for managing, maintaining, and supporting the BIOVIA ELN platform within laboratory environments. Primarily working in regulated industries like pharmaceuticals, biotechnology, and chemicals, this role ensures the ELN system is fully operational, secure, and configured to meet sci

Easy Apply

Contract

$30 - $40

Biovia Discoverant System Administrator

Remote

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27d ago

Biovia Discoverant System Administrator Remote - Nearshore/Offshore (Must Work in PST hours) Long-Term Rolling Contract Job Description: The BIOVIA Discoverant System Administrator is responsible for the deployment, configuration, maintenance, and performance optimization of the Discoverant platform. This role ensures system reliability, data integrity, and regulatory compliance across manufacturing and quality operations. The administrator collaborates with cross-functional teams to support l

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Contract

$30 - $40

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

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

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

Principal Agentic AI Chatbot Engineer

Remote or Thousand Oaks, California

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Today

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pat

Full-time

USD 189,750.00 per year

Principal SAP Architect, Enterprise Asset Management (EAM)

Remote

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Today

Full-time

USD 154,142.00 per year

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21 CFR Part 11 jobs in New Jersey, USA