21 CFR Part 11 Jobs in Dallas, TX

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LabVantage LIMS Architect

I.T. Solutions

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Remote

Contract

Role: Sr. LabVantage LIMS Architect Location: Remote Type: Contract Length: 3 months to start + Likely Extensions We are seeking an experienced LabVantage LIMS Architect to lead the design, configuration, and implementation of LabVantage Laboratory Information Management Systems (LIMS). The ideal candidate will possess deep technical expertise in LabVantage, a strong understanding of laboratory workflows, and a proven ability to align LIMS capabilities with business and regulatory requirements.
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Posted 15 hours ago

Veeva Integration Associate/Manager

SunTechPros, Inc.

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Remote

Contract

Veeva Integration Associate/ManagerRemote role, (If they local to Raleigh, NC that's a plus)W2 Position Position Overview: The Veeva Integration Associate will support the integration and optimization of Veeva Vault, Veeva CRM, and other Veeva applications within our organization. This role involves working closely with cross-functional teams to understand business requirements and translating them into effective technical solutions. You will be responsible for configuring, editing, and maintain
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Posted 2 days ago

MES Consultant

BOTG LLC

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Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact
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Posted 11 days ago

Computer System Validation Specialist

SGS Consulting

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Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r
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Posted 23 days 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 38 days ago | Updated moments ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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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 2 days ago | Updated 3 hours ago

Senior CQV Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 4 days ago | Updated 3 hours ago

Software Quality Engineer

Katalyst Healthcares and Lifesciences

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Irving, Texas, USA

Full-time

Responsibilities: Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications; Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc. Collaborate with the cross-functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met. Review of CAPAs, Change Controls and Defects for GxP applications. Working with Global teams and providing audit support. Work
Posted 2 days ago | Updated 3 hours ago

Trackwise Digital Architect

VeridianTech

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Texas, USA

Full-time

Trackwise Digital Architect Remote Requirement Experience with designing and implementing IT systems. Experience with understanding specifications, evaluate current application, gather requirements, and work closely with stakeholders to deliver the right solution Experience working and implementing systems using TrackWise Digital platform. Hands on experience in TrackWise Digital Application setup: Permission Sets, Configuring Platform Custom Settings, Configuring Remote Site Settings, E-s
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Posted 60+ days ago | Updated 1 day ago

Senior Software Quality Engineer

Johnson & Johnson

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Remote or Santa Clara, California, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 4 days ago | Updated 3 hours ago

Sr Manager, Data Sciences

Thermo Fisher Scientific

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Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest inve
Posted 41 days ago | Updated 3 hours ago

Lead, Technology Compliance

Johnson & Johnson

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Remote or Raritan, New Jersey, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m