FDA jobs in New Jersey

Remote

•

5d ago

Sr. JD Edwards (JDE) Developer / Remote / Contract About our Customer and Role: Our premium customer, a global Fortune 500 company & a leader in the Food Services industry is looking for a Sr JD Edwards Developer for designing, developing, implementing, and supporting custom solutions within the JD Edwards (JDE) EnterpriseOne environment. Responsibilities: Design & Development Develop, enhance, and maintain custom applications, modules, and interfaces within JD Edwards EnterpriseOne.Support & M

Easy Apply

Contract

Depends on Experience

Commercialization & Validation Engineer

Remote or Hybrid

•

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

Easy Apply

Contract

$70 - $75 per hour

*Sr. JD Edwards Developer* W2 Role

Remote

•

Today

Kellton Tech is a full-service software development company, offering end-to-end IT solutions, strategic technology consulting and product development services in Web, SMAC (Social, Mobile, Analytics, Cloud), ERP-BPM, and IoT space Our methodology of inventing infinite possibilities with technology helps us develop best in-class and cost effective solutions for our clients. Currently Kellton Tech is looking for talented resources for one of our listed client. Below are the position details Job

Easy Apply

Contract, Third Party

Depends on Experience

(100% REMOTE) Regulatory Affairs Reviewer Promotional Materials- 15 hours a week

Remote

•

Today

Degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.5 years experience in Regulatory Affairs advertising & promotion (ad promo) review or equivalent compliance function with overall RA experience of 10+ years.Strong knowledge of global and regional regulations governing promotional materials (e.g., FDA, EMA, IFPMA, local codes).Excellent attention to detail and ability to balance business needs with regulatory compliance.Strong communication skills to influence and guide cro

Easy Apply

Part-time

$80 - $100

Remote-Sr Business Analyst with Lifesciences client - CRM experience

Remote

•

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

Easy Apply

Third Party, Contract

Depends on Experience

Product Owner

Remote or Hybrid in Pittsburgh, Pennsylvania

•

Today

Company Overview: Req ID: 339286 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Product Owner to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). REMOTEJob Description: About the Role We are seeking a highly motivated and experienced Product Owner to support projects within the Heal

Easy Apply

Contract

BASED ON EXPERIENCE

Full Stack Engineer

Remote

•

7d ago

Full Stack Engineer - Remote (EST)Responsibilities Collaborate with your team to design, develop, test, deploy, and maintain secure, compliant SaaS solutions Build and enhance software features to address customer challenges and improve user experience Drive continuous improvement efforts and support CI/CD processes throughout the development lifecycle Promote and implement automation to streamline workflows, reduce manual effort, and ensure consistency Engage in all stages of product deve

Easy Apply

Full-time

$135000

Salesforce & TrackWise Digital Solution Architect

Remote

•

3d ago

Position: Salesforce & TrackWise Digital Solution ArchitectLocation: RemoteType: Contract / Full-time Job SummaryWe are seeking an experienced Salesforce & TrackWise Digital Solution Architect to lead the end-to-end design and implementation of scalable, compliant, and high-performance digital quality systems. The ideal candidate will bring strong expertise in solution architecture, system integration, and governance for regulated environments (Life Sciences / Pharma preferred). Key Responsibili

Easy Apply

Contract, Third Party

$100,000 - $160,000

Manager of Product Security / Medical Devices

Raritan, New Jersey

•

Today

Job Description A major medical device company is looking for a Product Security Manager to join their growing team! You'll play a critical role developing and presenting product security policies and metrics to management, while also helping bring pre-market cybersecurity products to the FDA. You'll work on a cutting-edge team that works with surgical robots! Ideal candidates have experience in product security, pen testing, vulnerability scanning, knowledge in coding with code review experien

Easy Apply

Full-time

70/hr - 100/hr

Computer System Validation - CSV Engineer

Remote or New Jersey

•

Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

R&D Quality Partner

Remote

•

21d ago

Job Title: R&D Quality Partner Diagnostics & Combination ProductsJob Location: RemoteType: W2/C2CDuration: 6 months (extensions possible)Start Date: ASAP Summary (Short JD):Seeking an R&D Quality Business Partner with strong expertise in diagnostics, medical devices, and drug-device combination products. This role will define and implement an R&D-focused Quality Management System (QMS), ensure compliance with FDA, EMA, ISO 13485/14971, EU IVDR, and 21 CFR regulations, and act as a strategic part

Easy Apply

Contract, Third Party

$35 - $45

Biostatistician/SAS

Remote

•

20d ago

Position: Biostatistician -Open Position-HI Type: contract Duration: 12 months Location: Hawai Responsibilities. Write/review SAP and clinical trial protocol; develop and validate complex statistical models and SAS programs for analysis, management & reporting of clinical data. Perform statistical analysis, create and verify clinical trial reports and TLGs to support FDA submission. Req.: Master's degree/equiv. in Biostatistics, Statistics, Public Health or related. Proficiency in clinical dat

Easy Apply

Contract

Depends on Experience

Computer System Validation Engineer

New Jersey

•

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

Statistician Clinical Trials & Predictive Biomarkers at Chicago, California & New Jersey PhD Must.

Jersey City, New Jersey

•

Today

Hi, Please check the job description as below and let me know you if you would be interested and available. Please let me know your available time for a quick call. Statistician Clinical Trials & Predictive Biomarkers Chicago, California & New Jersey PhD Must. 6+ Months Required Qualifications Possess a PhD in Statistics, Biostatistics, or a closely related quantitative field, along with over five years of experience as a statistician in clinical research. Demonstrated experience in designing

Easy Apply

Third Party, Contract

Statistician Clinical Trials & Predictive Biomarkers at Chicago, California & New Jersey PhD Must.

Jersey City, New Jersey

•

Today

Easy Apply

Third Party, Contract

Engineer Process Support II

Somerville, New Jersey

•

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 processes. Req

Full-time

Validation Engineer

Raritan, New Jersey

•

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

Process/Validation Engineer

Branchburg, New Jersey

•

Today

Job Description: What are the top 3-5 skills, experience or education required for this position. 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). Responsibilities: Implementing process and technology improvements. Process and Cleaning Validation. Equipment Quali

Full-time

Business Analyst - Pharmacy or PBM experience

Remote

•

Yesterday

Urgently looking to hire Business Analyst- Fulltime or Contract About the Role We are seeking an experienced Business Analyst with a strong background in pharmacy operations or pharmacy benefit management (PBM), or specialty pharmacy products. The Business Analyst will play a critical role in bridging business needs with technical solutions, ensuring that systems and processes align with regulatory requirements and support patient-centered pharmacy services. Key Responsibilities Partner with bus

Easy Apply

Full-time

Depends on Experience

Process Engineer

Fair Lawn, New Jersey

•

Today

Job Description: The Quality Process Engineer will be responsible for developing and maintaining process control systems to ensure consistent product quality, with a focus on supporting the insourcing of materials and components. This role leads cross-functional efforts to qualify internal processes, validate materials, and transition manufacturing activities from external suppliers. The engineer ensures compliance with GMP, GDP, and regulatory standards while driving process improvements, suppo

Full-time

Filter Results

Job post features

Posted date

Work settings

Employment type

Employer type

Work authorization

FDA jobs in New Jersey, USA