fda Jobs in new jersey

Refine Results
1 - 20 of 88 Jobs

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
Easy Apply
Posted 6 days ago | Updated 10 hours 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
Easy Apply
Posted 2 days ago

CSV CONSULTANT :: Remote

TESTINGXPERTS, INC. DBA DAMCOSOFT

•

New Jersey, USA

Contract, Third Party

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
Easy Apply
Posted 28 days ago | Updated 6 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
Easy Apply
Posted 58 days ago | Updated moments 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
Easy Apply
Posted 8 days ago | Updated 9 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)
Easy Apply
Posted 24 days ago | Updated 11 hours ago

PTC Arena Consultant

Teknikoz

•

Remote

Third Party, Contract

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an
Easy Apply
Posted 9 hours ago | Updated 8 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 3 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 3 days ago | Updated 3 hours ago

Process Engineer

Katalyst Healthcares and Lifesciences

•

Morristown, New Jersey, USA

Full-time

Responsibilities: Support activities within MSAT-US, including the development of technical documentation, SOPs, and internal systems. Provide technical expertise in packaging and Pharma processes, equipment, materials, and component performance. Investigate and recommend new packaging technologies, systems, and materials for potential integration into Company packaging and Pharma manufacturing systems. Provide project management support for CMC and packaging projects related to late-stage N
Posted 18 days ago | Updated 5 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
Easy Apply
Posted 2 days ago | Updated 3 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 22 days ago | Updated 5 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
Easy Apply
Posted 3 days ago | Updated 12 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 22 days ago | Updated 5 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 13 days ago | Updated 3 hours ago

Oracle Field Service Cloud Consultant

Prutech Solutions

•

Remote

Full-time

Oracle Field Service Cloud Consultant Full Time Job Duties and Responsibilities: Conduct thorough needs assessments to understand client requirements and identify opportunities for improvement.Design, configure, and implement Oracle's Field Service applications, including MES, FSM, SCM, and Quality Management solutions.Customize software to fit unique business processes and workflows.Integrate Oracle solutions with other systems and applications used by clients.Provide comprehensive training an
Easy Apply
Posted 7 hours 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 22 days ago | Updated 5 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
Easy Apply
Posted 3 days ago

Senior Expert Physicist

Spar Information Systems

•

US

Third Party, Contract

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
Easy Apply
Posted 6 days ago | Updated 2 hours ago

Offshore Remote role-SAP FunctionalSD/SM (Service Management)

Connexions Data Inc

•

Remote

Contract

SAP FunctionalSD/SM duration: 6 months to start Requirement for Functional SD/SM position Position level: Support Exp: ECC and S4 HANA Support 8 -10 years of hands-on experience with SAP ECC & S/4HANA in SD and SM modules.Strong expertise in Sales and Distribution, Logistics Execution, In-House Service, Customer Service, Samples, Rentals.Hands-on experience with Sales Orders, Delivery, Service orders, Service Notifications, Equipment master.Experience integrating SAP SM/SD with MM/ IM/WM, PP, C
Easy Apply
Posted 1 day ago | Updated 1 day ago