fda Jobs in raleigh, nc

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

Jobot

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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 2 days ago | Updated 1 hour ago

Lead IT Validation Consultant

Amaze Systems Inc

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New York, USA

Contract, Third Party

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 3 days ago | Updated 5 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 2 days ago | Updated moments ago

Computer System Validation Lead

Nityo Infotech Corporation

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Remote

Contract, Third Party

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 10 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

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 4 days ago

IT Project Manager Lead V - LIMS - Laboratory Information Management System/ LabVantage

Javen Technologies, Inc

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Remote

Contract

Job Title: IT Project Lead V LIMS Project Manager< class="MsoNormal">Location: Remote< class="MsoNormal">Duties: < class="MsoNormal">This role will assist with the implementation of a new Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) to be used across the organization starting in 2026.< class="MsoNormal">Domain Knowledge:<>Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage<>Understanding of clinical, research, or diagnostic
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Posted 10 hours ago | Updated 10 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 1 day 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 1 day ago | Updated 10 hours ago

SAP Developer Lead Remote Location

Sierra Business Solution LLC

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Remote

Contract, Third Party

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 1 day ago | Updated 12 hours ago

Commissioning and Qualification Engineer

Katalyst Healthcares and Lifesciences

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Raleigh, North Carolina, USA

Full-time

Responsibilities: Lead or support C&Q activities for pharmaceutical utilities and process equipment, ensuring compliance with industry standards and regulatory requirements. Execute FAT (Factory Acceptance Testing) to validate equipment functionality and performance. Support the qualification of Black and Clean utilities, such as water systems, clean steam, HVAC, and gas utilities. Perform process equipment qualification to meet GMP and production readiness standards. Develop and execute C&Q pro
Posted 60+ days ago | Updated 4 hours ago

Sr. SAS Programmer

Katalyst Healthcares and Lifesciences

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Durham, North Carolina, USA

Full-time

Responsibilities: The Sr. SAS Programmer will be responsible for statistical programming for the client's clinical studies. In this role, you will develop and validate SAS programs for data presentation, analyses, and provide programming support to project team members. Our Ideal candidate will have a strong work ethic capable of thriving in a high growth, fast paced and intellectual environment. Serves as lead programmer for assigned projects to provide statistical and programming support i
Posted 4 days ago | Updated 4 hours ago

CQV Engineer

Katalyst Healthcares and Lifesciences

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Holly Springs, North Carolina, USA

Full-time

Responsibilities: Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC). Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis. Supporting clients change management program - including authoring proposed changes, executing impact assessments/ regression analysis,
Posted 16 hours ago | Updated 4 hours ago

CQV Engineer-W2 ONLY

VetForce Solutions

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Holly Springs, North Carolina, USA

Contract

Title: CQV Engineer Location: Holly Springs, NC-onsite Duration: 6-12+ Months CQV Engineer Responsibilities (Typical): * Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC) * Managing and working collaboratively with clients quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis * Supporting clients change manag
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Posted 4 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Durham, North Carolina, USA

Full-time

Job Description: Reporting directly to the division Sterilization Quality Engineer Lead, this position involves support for the sterilization operations and product sterility assurance program. This position provides quality guidance for product and process sterility, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities. This
Posted 4 days ago | Updated 4 hours ago

Systems Engineer I/II - Server Admin (QC Support)

Novo Nordisk Inc

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Clayton, North Carolina, USA

Full-time

About the Department You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk's 50,000 employees. FFEx is a newly established and growing area with the responsibility to design, plan, and build
Posted 5 days ago | Updated 4 hours ago

Sr Manufacturing Tech - 2nd Shift

bioMerieux

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Durham, North Carolina, USA

Full-time

Position Summary & Responsibilities: The normal working hours for this role are anticipated to be 2nd shift: Monday - Friday from 3:00pm - 11:30pm. The Sr Manufacturing Technician position is responsible for the operation of high speed equipment used in the production and packaging of BacT/ALERT bottles in a cGMP compliant manner. ProductionOperate and maintain highly automated bottle handling, filling, vision inspection, conveying, robotic palletizing, autoclaving, labeling and / or process ba
Posted 1 day ago | Updated 14 hours ago

Manufacturing Engineer

Flowserve Corporation

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Raleigh, North Carolina, USA

Full-time

Flowserve is a world-leading manufacturer and aftermarket service provider of comprehensive flow control systems. Join a company whose people are committed to building a more sustainable future to make the world better for everyone. With 16,000+ employees in 50+ countries, we combine our global reach with local presence. Our team challenges themselves to approach each situation with ingenuity and creativity to help provide our customers with the most innovative flow control products and services
Posted 13 days ago | Updated 8 hours ago

Sr. Regulatory affairs Consultant-W2 ONLY

VetForce Solutions

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Remote

Contract

Sr. Regulatory affairs Our client is a rapidly expanding biotech company based in China that recently partnered with a major pharmaceutical company for research collaboration efforts, in hopes of discovering and developing novel oral drug candidates across multiple therapeutic indications (oncology, immunology, etc.) Our client is looking to bring on a Senior Regulatory Affairs Consultant (Senior/Director Level), who will provide strategic regulatory guidance as the client navigates the regulato
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Posted 1 day ago | Updated 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 1 day ago