21 CFR Part 11 jobs in Seattle, WA

Remote

•

Today

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

Easy Apply

Third Party, Contract

Depends on Experience

OT Solutions Architect – MES & SCADA (Application Architect – Operations Technology)

Remote

•

2d ago

We are seeking an experienced OT Solutions Architect specializing in Manufacturing Execution Systems (MES) and Supervisory Control and Data Acquisition (SCADA) to design, support, and deliver manufacturing technology solutions across multiple manufacturing sites. The ideal candidate will provide IT-side solution architecture and technical governance for Sepasoft MES and Ignition SCADA platforms, ensuring secure, scalable, and reliable integration between Operational Technology (OT) and enterpris

Easy Apply

Third Party, Contract

Depends on Experience

Manufacturing Data Strategy & Architecture Consultant

Remote

•

22d ago

Job title: Manufacturing Data Strategy & Architecture Consultant Location: Remote Position Overview Seeking a senior Manufacturing Data Strategy & Architecture Consultant to support the development of a future-state data vision, strategy, and architecture roadmap. The ideal candidate will bring deep expertise in pharmaceutical manufacturing data ecosystems, industrial data architectures, contextualization, semantics, and GxP-regulated environments. This role will serve as a trusted advisor to Pf

Easy Apply

Full-time, Third Party

Depends on Experience

SAP Validation

Remote

•

12d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

Easy Apply

Contract

Depends on Experience

Sr Technical Writer

Remote

•

6d ago

Hi, Hope you are doing well. Job Title: Sr IT Technical Writer Location: Remote Duration:12+ Months Job Description: We areseeking a Senior IT Technical Writer with 10+ years of experience to support technical documentation initiatives within a Bio-Pharma/Life Sciences environment. The consultant will work closely with IT, engineering, application, infrastructure, quality, validation, and business teams to develop accurate and compliant documentation for regulated systems. The role involves cr

Easy Apply

Contract

Depends on Experience

OT Solution Architect (MES/SCADA) -- C2C/W2 -- Remote

Remote

•

2d ago

Role: OT Solution Architect (MES/SCADA) Location: Remote Job Responsibilities:Work with ITside solution architecture for MES Sepasoft and SCADA Ignition systems across manufacturing sitesEnsure MES and SCADA solutions align with STERIS ITOT architecture, cybersecurity, and infrastructure standardsDevelop and maintain the enterprise MES/SCADA deployment playbook, including architecture standards, module selection criteria, implementation methodologies, and governance processes for Ignition an

Easy Apply

Contract, Third Party

Depends on Experience

Product Owner

Remote

•

6d ago

Iris's direct client, a leader in Healthcare services, looking to hire a strong Product Owner for a Long-Term Contractual role Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, Clinical Trial Platform Job Description: Product Manager Clinical Trial Platform Role Overview The Product Manager for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end-to-end clinical trial executio

Easy Apply

Contract

Depends on Experience

Senior Consultant - GxP & Clinical Quality Assurance

Remote

•

27d ago

Arthur Lawrence is looking for a Senior Consultant - GxP & Clinical Quality Assurance one our clients project based on Remote. Please find the job description below and send us your updated resume if interested: Must-Have Skills:10+ years of GxP Quality Assurance experience in biopharma, biotech, or medical devices, including 3+ years at Senior Manager or Director level. Hands-on expertise in Google Cloud Platform site audits, CRO governance, TMF management, and FDA BIMO inspections. Strong ex

Easy Apply

Third Party, Contract

$70 - $75

SENIOR PRODUCT OWNER

Remote

•

3d ago

Hi, Greetings from Iflowsoft Solutions Inc Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, with Clinical Trial Platform experience-- MUST Job Description: Product Manager Clinical Trial Platform Required Qualifications Bachelors degree in life sciences, engineering, product management, or related field. 12+ years of product management experience, ideally within clinical trials, healthcare technology, or regulated SaaS platforms. Strong understanding of

Easy Apply

Full-time

Depends on Experience

Loftware Spectrum Technical Lead / Solution Engineer @ Remote

Remote

•

Today

Position: Loftware Spectrum Technical Lead / Solution Engineer Location: Remote Duration: 6+ months Job Description: Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable g

Easy Apply

Contract, Third Party

Depends on Experience

Sr. Manager – Forward Deployed Engineering

Remote

•

Today

Sr. Manager Forward Deployed Engineering Remote (USA) Must Have: surgical/ clinical domain experience Role Overview As an Engagement Manager, you will lead end-to-end delivery of surgical AI solutions deployed directly at hospital sites for a global MedTech client. You are the single point of accountability for your Forward Deployed Engineering (FDE) pod, owning everything from discovery and scoping through production deployment and ongoing operations. This role combines technical leadership, c

Easy Apply

Contract, Third Party

Depends on Experience

Planisware PPM Administrator w/ Power BI

Remote

•

Today

Systems / Data Analyst Location: Remote (Easter Time Zone) Contract Duration: 12 Months plus Start Date: ASAP About the Role Our client is seeking an experienced Systems / Data Analyst to support its Technical Services organization within the pharmaceutical and life sciences industry. This position will serve as the primary Planisware System Administrator, with responsibility for platform configuration, governance, user access, and ongoing enhancements. The Systems / Data Analyst will also d

Easy Apply

Contract

Sr SampleManager Implementation Engineer

Remote or Indiana

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior SampleManager LIMS Implementation Engineer How will you make an impact? As a Senior SampleManager LIMS Implementation Engineer, you will be a technical expert responsible for the configuration, implementation, integration, and deployment of Thermo Scientific SampleManager LIMS solutions. This role is highly hands-on and focused on translating defined laboratory processes and solution designs into robus

Full-time

USD 93,800.00 - 140,675.00 per year

GxP Systems and Support Administrator

Remote

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Solutions Engineer, Life Sciences

Remote

•

30+d ago

Who we are At Domino, we build software that helps the largest, AI-driven organizations build and operate advanced data science and AI solutions at scale. Our platform integrates a streamlined model development environment, MLOps capabilities, and novel features for collaboration, reuse, and reproducibility - all of which make data science teams more productive, reduce time to value, and ensure compliance. Our customers - like Johnson & Johnson, GSK, Bristol Myers, UBS, FINRA and the US Navy -

Full-time

USD 160,000.00 - 230,000.00 per year

Senior Manager, Global Digital & Technology System Ownership

Remote

•

Today

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. BeOne is a global biopharmaceutical company dedicated to the discovery and development of innovative drug therapies for the treatment of cancer. At BeOne we believe that access to life-changin

Full-time

USD 136,900.00 - 181,900.00 per year

Platform Information Security Officer (PISO), Life Sciences Platform

Remote

•

Today

Bring more to life. At Danaher, our work saves lives. And each of us plays a part. Fueled by our culture of continuous improvement, we turn ideas into impact - innovating at the speed of life. Our 60,000+ associates work across the globe at more than 15 unique businesses within life sciences, diagnostics, and biotechnology. Are you ready to accelerate your potential and make a real difference? At Danaher, you can build an incredible career at a leading science and technology company, where we

Full-time

USD 225,000.00 - 275,000.00 per year

Senior Manager, Global Digital & Technology Systems Engineering

Remote

•

Today

Full-time

USD 136,900.00 - 181,900.00 per year

Senior Manager, Global Digital & Technology Systems, Veeva Administrator

Remote

•

Today

Full-time

USD 136,900.00 - 181,900.00 per year

Associate Director, Biostatistics & AI

Remote

•

4d ago

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare dis

Full-time

USD 173,800.00 - 217,000.00 per year

21 CFR Part 11 jobs in Seattle, WA, USA