FDA Jobs in New Jersey

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W2 only Software Quality Assurance Consultant - EST/CST Only - regulatory affairs Medical Devices, software development life cycle risk management and configuration management FDA

APN Software Services, Inc

•

Remote

Contract

Please contact Abdul on "" OR email me at "" Job Responsibilities: Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements. 2. Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test pl
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Posted 4 days ago | Updated 1 day ago

Validation Lead

Nityo Infotech Corporation

•

Raritan, New Jersey, USA

Third Party, Contract

Minimum 3+ years experience with SAP or Blue Yonder Warehouse Management Systems3+ years experience with System Development Lifecycle3+ years experience in Computer System ValidationExperience with FDA CSA principles Experience with J&J CSV Framework 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 documentation for all asp
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Posted 13 hours ago

CSV CONSULTANT :: Remote

TESTINGXPERTS, INC. DBA DAMCOSOFT

•

New Jersey, USA

Third Party, Contract

Mandatory Skills CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ), Veeva, Argus, Defect Tracking Tools_JIRA Primary Skill- Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management Secondary Skill- JIRA Veeva Argus Agile and Waterfall methodology Jo Description: Strong experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems P
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Posted 26 days ago | Updated 12 hours ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

•

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 56 days ago | Updated 4 hours ago

Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)

Amerit Consulting

•

Remote

Contract

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Software Program Manager NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099) Candidate must be authorized to work in USA without requiring sponsorship Position: Medical Devices Software Program Manager(Job Id - # CFNJP00051124) Location: San Diego CA 92130 (Remote) Duration: 6 months + Contract to
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Posted 6 days ago | Updated 13 hours ago

Business Quality Assurance (BQA)

Activesoft, Inc.

•

Remote

Contract

Mandatory Skills & Qualifications: Strong knowledge in GMP, cGMP, and regulatory standards:21 CFR Part 1121 CFR Part 21021 CFR Part 211ICH Q7Experience facing FDA audits at pharmaceutical manufacturing sitesHands-on experience with manufacturing processes, CAPAs, deviations, etc.Lead Auditor or any other compliance certifications (preferred)
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Posted 22 days ago | Updated 13 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract , remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Acti
Posted 1 day ago | Updated 7 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract, remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Active
Posted 4 days ago | Updated 7 hours ago

Regulatory Labeling Specialist

System One

•

Plainsboro Township, New Jersey, USA

Contract

Job Title: Regulatory Labeling Specialist Compensation: $95000 - $110000 annually depending on years of experience Location: Can be fully remote Employee Classification: Joule FTE - Salary + 20 days of PTO + 10 Holidays - 401k benefits/etc. JOB TITLE : Labeling Specialist - REGULATORY OPERATIONS LOCATION : Can be onsite/remote or hybrid MUST HAVES: LABELING DEVELOPMENT SPL PREPARATION AND SUBMISSION STRONG TECHNICAL KNOWLEDGE OF SYSTEMS/SOFTWARE: LIFT, ALiCE, Veeva Vault, TVT, NovoGlow MINIMUM
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Posted 7 hours ago

Automation Control Engineer

Katalyst Healthcares and Lifesciences

•

South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa
Posted 20 days ago | Updated 10 hours ago

Drug Safety Scientist

Sunrise Systems, Inc.

•

Remote

Contract

Job Title Drug Safety Scientist Job ID: 25-08470 Location: 100% Remote (Candidates should be in EST only) Duration: 12 months on W2 Contract Summary: Seeking an experienced Drug Safety Scientist with 5+ years in pharmacovigilance to support regulatory safety reporting and risk management. Must hold a Bachelor's/Master s in Pharmacy, Biotechnology, or Chemistry. Key Responsibilities: Author safety reports (DSUR, PBRER, PADER)Support signal detection and safety data evaluationConduct literature
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Posted 1 day ago | Updated 18 hours ago

Mechanical & Biomedical Engineer

Katalyst Healthcares and Lifesciences

•

Belleville, New Jersey, USA

Full-time

Responsibilities: Lead/contribute to device development, design controls and risk management strategy for the assigned projects. Lead the implementation and/or ensure effective execution of the device development strategy, design controls and risk management activities for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers. Proactively resolve project
Posted 20 days ago | Updated 10 hours ago

Pharmaceutical Equipment Commissioning & Qualification Engineer

Zachary Piper Solutions, LLC

•

Hopewell Township, New Jersey, USA

Full-time

Piper Companies is currently seeking a Pharmaceutical Equipment Commissioning & Qualification Engineer for an opportunity in Titusville, New Jersey or Raritan, New Jersey , to join a global pharmaceutical company. Responsibilities: Maintain, calibrate, qualify and validate equipment used in the production, testing and packaging of pharmaceutical products Develop, execute, and document equipment qualification protocols and test plans in accordance with cGMP regulations and industry standards C
Posted 11 days ago | Updated 7 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Allendale, New Jersey, USA

Full-time

Responsibilities: Work under the direction of the Validation Lead and/or function as the validation lead for a project team. The Validation Engineer will be required to support multiple projects simultaneously. Develop and execute IQ, OQ, and PQ protocols for products, processes, facilities, software, and equipment within the facility. Experience authoring Validation Plan documents, User Requirements, Traceability Matrix, and Validation Summary Reports. Write reports summarizing results and s
Posted 20 days ago | Updated 10 hours ago

Remote Senior QA Test Manger/QA Leader with Strong Healthcare Domain

Infinite Computer Solutions (ICS)

•

Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Descriptions : We are looking for an experienced Senior QA Healthcare Manager/QA Leader to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: Lead and manage the QA t
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Posted 1 day ago

Senior Expert Physicist

Spar Information Systems

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US

Contract, Third Party

Looking for a Senior-Level Expert-preferably a scientist or physicist-with hands-on experience designing, developing, and troubleshooting magnetic tracking systems, especially in medical device or similar precision environments. Key Requirements: Domain-Specific Expertise Must have direct experience building and shipping magnetic tracking solutions-ideally used in catheter navigation, cardiac, gastrointestinal, or surgical tracking systems. Should be deeply familiar with electromagnetic field be
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Posted 4 days ago | Updated 3 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 20 days ago | Updated 10 hours ago

Senior Level Expert Scientist or Physicist

Spar Information Systems

•

US

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

Hello; Senior Level Expert Scientist or Physicist Job Location:-Remote Long Term Senior-Level Expert-preferably a scientist or physicist-with hands-on experience designing, developing, and troubleshooting magnetic tracking systems, especially in medical device or similar precision environments. Key Requirements: 1. Domain-Specific Expertise Must have direct experience building and shipping magnetic tracking solutions-ideally used in catheter navigation, cardiac, gastrointestinal, or surgical
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Posted 4 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Raritan, New Jersey, USA

Full-time

Role & Responsibilities: 3-7 years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area. Has working experience in any one or two of the following domains Tool validation like ServiceNow, Automation tools, JIRA . Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. pplication of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 2
Posted 20 days ago | Updated 10 hours ago

DeltaV Automation Engineer - Pharmaceuticals

Zachary Piper Solutions, LLC

•

Remote

Full-time

Piper Companies is hiring a DeltaV Automation Engineer for a growing BioPharma company located in Holly Springs, NC. The DeltaV Automation Engineer will be responsible for designing, developing, and maintaining automation systems for pharmaceutical manufacturing processes. This role requires expertise in Emerson DeltaV DCS (Distributed Control System), with a focus on process optimization, validation, and compliance with industry regulations. The DeltaV Automation Engineer can work remote, but w
Posted 4 days ago | Updated 7 hours ago