FDA Jobs in New York, NY

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Sr 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: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing
Posted 1 day ago | Updated 3 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 60+ days ago | Updated 1 hour ago

Lead IT Validation Consultant

Amaze Systems Inc

•

New York, USA

Third Party, Contract

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used
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Posted 2 days ago | Updated 5 hours ago

Technical Writer Asset Management Systems (Life Sciences) - Remote

DivIHN Integration Inc.

•

US

Contract

DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent. Visit us at to learn more and view our open positions. Please apply o
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Posted 4 hours 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 1 day ago | Updated 1 hour ago

Document Management Specialist | Remote | Contract

Walker Healthforce

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Remote

Contract

Document Management Specialist | Remote | Contract Walker Healthforce is seeking a Document Management Specialist with +4 years of experience. This is a contract opportunity. CORE REQUIREMENTS:An A.A. in Business or English (or related) with four (4) years of experience OR Bachelor of Arts degree.Strong writing skills with good grammar.Attention to detail.Able to work on multiple documents in parallel.Able to create simple forms and templates.Must be able to use MS Office tools and interact with
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Posted 3 days ago

Statistical Programmer

Georgia IT

•

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 9 hours 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 12 hours ago

SAP Developer Lead Remote Location

Sierra Business Solution LLC

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Remote

Third Party, Contract

Job Description: >> Lead SAP development projects and provide technical guidance across modules and platforms. >> Manage and coordinate activities of an offshore SAP development team, ensuring high-quality deliverables. >> Develop, enhance, and maintain SAP applications using SAP Workflow, FioriUI5, Web Dynpro (ABAPJava), SAP Enterprise Portal, BRF+ (Business Rule Framework Plus), LSMW (Legacy System Migration Workbench). >> Perform root cause analysis and debugging of complex SAP issues across
Posted 5 hours ago

Statistical Programmer & Senior Biostatistician

Interpro Inc.

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Remote

Contract

Interpro has been in the IT consulting business since 1993 and our employees work on a range of projects across the country.We have a long-term opportunity as described below: Remote working-EST hours Statistical Programmer 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 pr
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Posted 60+ days ago | Updated 9 hours ago

Python Developer

Hired by Matrix, Inc.

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Remote or Nutley, New Jersey, USA

Contract

At-a-Glance: Are you ready to build your career by joining a global pharmaceutical company. If so, our client is hiring a Python Developer.Position Type: Contract RemoteRequired: Master s degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development Strong understanding of SDTM standards and CDISC requirements. Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms). Familiarit
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Posted 13 hours ago | Updated 1 hour ago

Adobe Campaign Technical Lead/Architect

Codinix Technologies Inc.

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New York, New York, USA

Contract

Job Description We are seeking an experienced and strategic Adobe Campaign Technical Lead / Architect to lead our marketing technology initiatives. The ideal candidate will possess a deep understanding of Adobe Campaign platforms and related Adobe Experience Cloud tools, with a strong track record of designing and implementing scalable, data-driven marketing solutions. This role requires both hands-on technical skills and leadership capabilities to drive innovation and campaign effectiveness. Wo
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Posted 41 days ago | Updated 14 days ago

Mechanical & Biomedical Engineer

Katalyst Healthcares and Lifesciences

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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 60+ days ago | Updated 6 hours ago

Manager, Regulatory Compliance

Cleerly

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New York, New York, USA

Full-time

About the Opportunity We are a growing startup company focused on developing and distributing machine learning (artificial intelligence) solutions for medical applications. The Manager, Compliance must be a subject matter expert in compliance, encompassing domestic and international regulatory, quality, and related requirements. Responsible for proactively monitoring all relevant compliance changes and guiding the company to maintain adherence and achieve strategic success.. You'll be joining a
Posted 22 days ago | Updated moments ago

Automation Control Engineer

Katalyst Healthcares and Lifesciences

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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 60+ days ago | Updated 6 hours ago

Sr. Mechanical Engineer

Katalyst Healthcares and Lifesciences

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Rahway, New Jersey, USA

Full-time

Responsibilities: Apply subject matter expertise in mechanical design, analysis, and system development. Conceive and develop solutions to complex analytical, pneumatic, mechanical, and electrical design challenges. Establish design objectives and contribute to writing specifications and comprehensive engineering reports. Participate in the review and development of detailed product specifications. Conduct conceptual and detailed design studies using MCAD, Solidworks, and other tools. Coll
Posted 51 days ago | Updated 6 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Summit, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems. Develops
Posted 13 days ago | Updated 6 hours ago

Process Engineer

Katalyst Healthcares and Lifesciences

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Morristown, New Jersey, USA

Full-time

Responsibilities: Support activities within MSAT-US regarding technical documentation, SOP's, and internal systems. Development of technical positions regarding packaging and Pharma process, equipment, material and component performance and Regulatory compliance for Company packaging process practices. Investigating and recommending new packaging and Pharma processes, technologies, systems, and materials, for potential integration into Company packaging and Pharma manufacturing systems. Provi
Posted 60+ days ago | Updated 6 hours ago

Sanitation Director

WinMax Systems Corporation

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Linden, New Jersey, USA

Full-time

Title: Sanitation DirectorLocation: Linden, NJ OR Lancaster, TX with Travel Full Time Job Description: We are seeking a strategic and results-driven Sanitation Director to lead the development, implementation, and oversight of a standardized sanitation program across our manufacturing network. This high-impact, corporate-level role will be instrumental in streamlining operations, enhancing regulatory compliance, and driving continuous improvement through unified processes. The ideal candidate wi
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Posted 16 days ago

USA-Process Engineer III (Engineering)

Katalyst Healthcares and Lifesciences

•

Morristown, New Jersey, USA

Full-time

Responsibilities: Support activities within MSAT-US regarding technical documentation, SOP's, and internal systems. Development of technical positions regarding packaging and Pharma process, equipment, material and component performance and Regulatory compliance for Client packaging process practices. This includes investigating and recommending new packaging and Pharma processes, technologies, systems, and materials, for potential integration into Client packaging and Pharma manufacturing sys
Posted 60+ days ago | Updated 6 hours ago