21 CFR Part 11 jobs in Seattle, WA

Bellevue, Washington

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Today

Job Description: Experience Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development

Full-time

Validation Lead

Remote

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11d ago

Job Title: Validation Lead Location: Fully remote Duration: Long term contract Educational Qualification* BE, Comp Science, BCA, BSE computer science Job Description of Role* (RNR) Proven leadership in testing/validation for medium to large system implementations, ensuring GxP compliance and quality delivery. Extensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomes. Proficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoi

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Full-time, Third Party

$0 - $0

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's

Full-time

Business Analyst - Clinical Validation Testing

Remote

•

Today

Business Analyst with Validation Testing Required Skills & Qualifications: Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field. Proven experience (5+ years) in clinical quality assurance, software validation, or clinical systems QA. Strong knowledge of GxP guidelines, FDA regulations, and compliance standards (21 CFR Part 11, GDPR, HIPAA). Experience with clinical trial management systems (CTMS), electronic data capture (EDC), or Veeva Vault Clinical. Proficiency

Contract, Third Party

Veeva Presales Consultant

Remote

•

Today

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content

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Contract

Depends on Experience

Backend .NET API Developer (Health Care) - Remote

Remote

•

Today

Title: Senior Backend .NET API Developer Client : Augusta Location: REMOTE Duration: 3 Months with Possible Extension Work Hours: 40hrs/week Key Responsibilities API Development & Architecture AWS DynamoDB Expertise Cloud & Infrastructure Required Qualifications Technical Skills 10+ years of professional software development experience. Strong experience in .NET Core / ASP.NET Core, C#, and object-oriented programming. Proven expertise in AWS DynamoDB (data modeling, performance tuning, and oper

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Third Party

$50 - $55

Controls Engineer (DeltaV)

Remote or Kalamazoo, Michigan

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Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

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Full-time

USD 120,000.00 - 160,000.00 per year

Lead Engineer - MES Opcenter

Remote or New York

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Today

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new

Full-time

Aveva / OSIsoft PI Integration AWS Developer

Remote

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25d ago

Location: 100% Remote Duration: 12 Months Job Description: Seeking a hand-on and experienced Senior Developer with 5+ years of experience in core AWS services. They will work with the team to design, build, and apply best practices. Key Responsibilities: The ideal candidate will have strong programming skills with extensive experience in AWS services.Design and implement back-end services using AWS lambda, Glue, Step Functions, API Gateway, S3, Aurora Postgres, Event Bridge and CloudWatch.Exper

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Contract

$80 - $85

Director Contract Research Organization (CRO) SME (Customer Success)

Remote

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13d ago

Director Contract Research Organization (CRO) SME (Customer Success)Location: RemoteDepartment: Customer Success Role OverviewWe are seeking a Director level Contract Research Organization (SME) with deep expertise in Clinical Data Management (CDM) and a modern understanding of clinical data workflows and analytics. This individual will play a critical dual role in ensuring delivery excellence across customer engagements and supporting strategic sales and pre-sales efforts. This is a highly visi

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Full-time

Depends on Experience

IT Enterprise Architect with Life Science Experience

Remote

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25d ago

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: IT Enterprise Architect with Life Science Experience Location: Boston, MA (Remote) Duration: 12+ months Job Description: The IT Enterprise Architect is a key role within Gates MRI IT, combing a blend of deep technical and architectural expertise with industry foresight, and strategic thinking. This position is essential for crafting a cohesive IT architecture that sup

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Third Party, Contract

Depends on Experience

Senior Commissioning, Qualification & Validation (CQV) Engineer

Remote or Athens, Georgia

•

Today

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

Full-time

Sr Manager, IT Business Analysis - SAP BRH Architect

Remote or Foster City, California

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Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 169,320.00 - 219,120.00 per year

Systems Administrator

Remote or Tennessee

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Today

It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives

Full-time

Sr. Manager, SAP CGTO Solutions Architect

Remote or Santa Monica, California

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Today

Full-time

USD 153,935.00 - 199,210.00 per year

Principal SAP Architect, Enterprise Asset Management (EAM)

Remote

•

Today

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pat

Full-time

USD 154,142.00 per year

Computer System Validation Analyst - R Studio & Clinical Systems

Remote or New Jersey

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Today

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

Full-time

Sr. CSV Validation Lead/Engineer _ Bothell, WA ( Day1 onsite)

Bothell, Washington

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5d ago

Requirement details: Job Title: Sr. CSV Validation Lead/Engineer Location: Bothell, WA ( onsite) Duration : 12+ Months Job Description: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality i

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Contract, Third Party

Depends on Experience

LIMS and QC Applications Consultant

Remote or Hybrid in Bridgewater, New Jersey

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Today

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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Full-time, Contract

BASED ON EXPERIENCE

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21 CFR Part 11 jobs in Seattle, WA, USA