FDA Jobs in New Jersey

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Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

•

US

Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Design/Build Solutions to meet our Clients
Posted 4 hours ago

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

•

US

Full-time

Sr Mechanical/Process Design Engineer - Technical Lead (Cleanrooms/Pharma/Healthcare/cGMP) - Remote (East Coast Preferred) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Des
Posted 1 day ago | Updated 4 hours ago

Business developer Manager- Medtech/Healthcare

Showman Staffing

•

Remote

Full-time

Job Title: Sr.Business Developer Manager Experience: 6+yrs Location: Remote-Travel required-100% client location-Candidates should be in USA Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to bring c
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Posted 2 hours ago

FSQA - Food Safety and Quality Assurance Manager

Agile Global Solutions, Inc

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Linden, New Jersey, USA

Full-time

Position Overview: The FSQA Leader will play a key role in advancing the facilitys food safety and quality programs, ensuring alignment with regulatory standards (FDA, USDA, HACCP, FSMA), customer expectations, and internal best practices. This position offers an exciting opportunity to contribute to a dynamic, forward-thinking culture focused on quality, innovation, and operational excellence. Key Responsibilities: Lead, enhance, and support food safety and quality assurance programs, including
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Posted 3 days ago | Updated 3 days ago

Computer System Validation Lead

Nityo Infotech Corporation

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Remote

Third Party, Contract

Job Details: 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA Gu
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Posted 4 days ago

Compliance Head, U.S. FDA

Sanofi

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Morristown, New Jersey, USA

Full-time

Job DescriptionJob Title: Compliance Head, U.S. FDA Location: Framingham, MA (Primary); Morristown, NJ, Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Foster best-in-class performance by leveraging data, techno
Posted 34 days ago | Updated 5 hours ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated moments ago

Business Analyst

NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 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 Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil
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Posted 5 days ago | Updated moments ago

GMP/Pharma Manufacturing Operator (2nd Shift)(ONSITE)

NetSource, Inc.

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Raritan, New Jersey, USA

Contract

Please note that this is a 1-year contract. This role will be 2nd Shift 3pm 11:30PM / M F Requirements: GMP document experience. High School Diploma required; Bachelor s Degree preferred 3+ years of experience in medical device or pharmaceutical manufacturing Experience using SAP is preferred Proficient with using MS Office (Word, Excel, Outlook) Strong mechanical problem-solving ability and technical aptitude Ability to work independently with limited supervision and work as part of a team Able
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Posted 19 days ago | Updated 22 hours ago

Statistical Programmer

Georgia IT

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Remote

Contract

Statistical Programmer Remote Duration: 12+ Months Rate: DOE Key responsibilities At least 5 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.Collaborate with statisticians and data managers to define dataset specifications and outputsEnsure compliance with internal SOPs, CDISC standards,
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Posted 4 days ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

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Remote

Contract, Third Party

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce
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Posted 5 days ago | Updated 1 hour ago

Technical Lead AWS

Trigent Solutions

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Remote

Full-time

Job Title: Technical Lead AWS (AI/ML Experience Preferred) Client: U.S. Food and Drug Administration (FDA) Position Type: Full-time | Permanent Location: 100% Remote Job Summary: We are seeking a highly skilled Technical Lead to support our ongoing initiatives with the FDA. The ideal candidate will have a strong technical background, leadership experience, and a passion for innovation, with machine learning (AI/ML) experience being a strong plus. This is a long-term, fully remote opportunity wi
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Posted 1 day ago

Regulatory Studio CMS Senior Manager

CBase Inc

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Jersey City, New Jersey, USA

Full-time

Job Title: Regulatory Studio CMS Senior ManagerLocation: 100% Onsite New Brunswick (preferred) or Lawrenceville, NJDuration: 11 Months Contract Top Required Skills / Must-Haves: 2 3 years of Small Molecule Drug Development experienceHands-on experience with Veeva System (Documentum)Strong verbal and written communication skills5+ years in the pharmaceutical industry3+ years CMC regulatory experience (Sterile Injectable experience preferred) The highlights are as below: - Experience with Veeva
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Posted 1 day ago

Senior Biostatistician

Georgia IT

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Remote

Contract

Senior Biostatistician Remote Duration: 12+ Months Rate: DOE At least 8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (CDISC, ICH, FDA/EMA gu
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Posted 4 days ago

Senior Biostatistician

System Edge (USA) L.L.C.

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Remote

Contract

Position: Senior Biostatistician Location: Remote/EST time zone Contract- Long termAt least 6-8years of experienceIn Addition to the above Statistical Programming II experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (
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Posted 4 days ago

SENIOR UX DESIGNER/Medical Device/Product Development - CTC

Care IT Services Inc

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Remote

Contract

Job Description: INDUSTRY BACKGROUND REQUIRED Candidates must have direct experience designing user interfaces for regulated, complex product ecosystems. Acceptable industries include: Medical devicesSurgical platformsHealthcare technology involving hardware/software integrationOther industries with high technical complexity and regulatory oversightPreferred employers include: Apple (hardware), Meta (Reality Labs), GE Healthcare, Medtronic, Stryker, Philips, Smith & Nephew REGULATORY EXPERIENCE
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Posted 3 hours ago

Data Science/ML Engineer

People Force Consulting Inc

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Remote

Contract

We are seeking a highly skilled Senior Machine Learning Engineer to join the Foundational Data Analytics (FDA) Program, a strategic initiative focused on building a modern, intelligent data ecosystem. This role will lead the design, development, and deployment of machine learning models that support enterprise-wide analytics, predictive insights, and healthcare transformation. FDA Program Objectives: Single Source of Truth (SSOT): Build standardized, high-quality data infrastructure ensuring con
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Posted 5 days ago | Updated 4 hours ago

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

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Newark, New Jersey, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.
Posted 2 days ago | Updated 7 hours ago

Statistical Programmer

Georgia IT

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Remote

Contract

Job Title: Statistical Programmer Location: Remote Key Responsibilities Develop, validate, and maintain SAS programs for statistical analysis, regulatory submission, and reporting deliverables. Create analysis datasets (ADaM) and tables, listings, and figures (TLFs) for clinical trial data analysis. Collaborate with statisticians and data managers to define specifications for datasets and statistical outputs. Ensure compliance with CDISC standards, internal SOPs, and regulatory guidelines (FDA,
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Posted 4 days ago

Regulatory Studio CMS Senior Manager

Sureminds Solutions

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New Brunswick, New Jersey, USA

Contract, Third Party

Job Title: Regulatory Studio CMS Senior Manager Location: New Brunswick, NJ/ Lawrenceville, NJ (Onsite) Duration : 11 Months Interview Mode : Video Job Description : Top 3 to 5 skills/Must Haves: Small Molecule Drug development experience (2 to 3 years)Good communications skills (written/verbal)Experience with Veeva System PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory exper
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Posted 1 day ago