21 cfr part 11 jobs in bend, or

Bend, Oregon

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Today

CQV Validation Specialist/ CSV/CQV Specialist Location: Bend, OR (Onsite) Duration: 6-9 Month Contract Interview Process: Initial Teams interview followed by a panel interview (Teams or onsite; onsite may be required). Hiring Manager Notes Immediate need due to a significant CQV validation backlog.Strong preference for candidates with analytical laboratory experience.Must be comfortable balancing priorities between CQV and Instrumentation teams.Onsite presence in Bend is required to support in

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Contract, Third Party

Depends on Experience

CMO Digital Liaison & Data Steward

Remote

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Today

Business Analyst / Digital Steward CMO Connections Role Overview We are seeking a technically grounded Business Analyst / Digital Steward to support digital connections with external Contract Manufacturing Organizations (CMOs). This person will help own the digital engagement with external manufacturing partners end to end from partner onboarding and tech transfer through commercialization and long-term sustainment of inline products. The role operates across a matrixed portfolio of strategic CM

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Contract

Depends on Experience

Clinical Project Manager with RBQM, Veeva, CTMS, eTMF, EDC

Remote

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12d ago

Title: Clinical Project Manager with RBQM & Veeva Foster City, CA or Remote for people who can travel for meetings Experience Range: 10- max 22 years Writeup Skills PM with BA background and experience 6+ years of proven expertise in theclinical domain and operations, including hands-on experience with systems likeCTMS, eTMF, RBQM, and EDC. 8+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. 6+ years of

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Full-time

Depends on Experience

Validation Engineer 2

Bend, Oregon

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Today

Job Description: Client is seeking a contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV department. This role will provide validation support for analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with both the Instrumentation and CQV teams. The successful candidate will split time supporting Dawn Bosco's CQV priorities and the Instrumentation team's CSV activities. This

Full-time

SAP BRH Functional / Support Lead

Remote

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Today

Job Summary: Seeking a Senior SAP Batch Release Hub (BRH) Functional/Support Lead with strong SAP BRH and S/4HANA QM expertise to support implementation, production sustainment, hyper care, and go-live activities in a regulated Life Sciences environment. Key Responsibilities Lead SAP BRH implementation, design, and production support. Handle P1/P2 incidents, RCA, defect resolution, integration troubleshooting, and hypercare. Support S/4HANA QM, including batch management, inspection lots, usage

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Contract

Depends on Experience

Mendix Platform Architect

Remote

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3d ago

Mendix Platform Developer/Architect|| Location Jacksonville, FL Remote || Employment type - contract Job Description: 10 years of software development experience. 5 years of Mendix development experience Experience serving as a solution architect or technical lead. Experience delivering enterprise-scale applications. Technical Skills Mendix Platform Architecture Mendix Studio Pro Microflows and Nanoflows Domain Modeling XPath and OQL Java Actions REST and SOAP APIS SQL Databases Azure

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Third Party, Contract

$65 - $70

Senior Engineering/ IT Program Manager

Remote or Ponce, Ponce

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Today

Job Title: Senior Engineering/ IT Program Manager Client: Medical Device Manufacturing Company Duration: 12 Months Location: 100% Remote (Travel to Ponce, Puerto Rico as needed) Role Overview Lead large cross-functional engineering programs Support manufacturing, digital transformation, and regulated systems Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership Manage enterprise engineering programs Build roadmaps, milestones, and resource plans Deliver withi

Full-time

Business Application & Systems Administrator

Remote or Boston, Massachusetts

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Today

Job Description The Business Applications & Systems Administrator is responsible for managing, implementing, and optimizing business applications. The role will develop & coordinate testing with impacted departments, including specifically coordinating with IT and Quality for validation & compliance. Manages business application projects, ensuring effective communication across teams/functions as well as informing management of progress and key issues. Key Responsibilities Application Managem

Full-time

USD 116,800.00 - 219,000.00 per year

Senior PLM Windchill Solution Architect

Remote

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5d ago

Position OverviewWe are looking for aSenior PLM Windchill Solution Architectto lead a strategic, customer-facing PLM engagement for a leadingMedical Device / Life Sciences organization.The ideal candidate will be a senior techno-functional architect with strongPTC Windchill PLMexpertise and experience owning end-to-end architecture, technical governance, integrations, migration, validation, AMS, and customer stakeholder management.Key ResponsibilitiesLead end-to-endPTC Windchill PLM solution arc

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Contract

80 - 90

Senior Technical Business Analyst

Remote

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6d ago

DescriptionJob Title: Senior Healthcare Business Analyst Type: Part Time Experience Level: Senior Seeking a highly skilled and experienced Senior Business Analyst responsible for bridging the gap between business objectives and technology solutions, ensuring that our projects align with organizational goals and deliver maximum value. You will utilize your expertise in business analysis and data-driven decision-making to identify opportunities for improvement and drive successful project outcomes

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Part-time

Depends on Experience

Sr SampleManager Implementation Engineer

Remote or Indiana

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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

Project Manager- Life science industry

Remote

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14d ago

Job Title: Project ManagerLife science industryLocation: Foster City, CA (Fully remote)Duration: FTEEducational Qualification*Any Bachelor''s DegreeExperience Range10 YearsTagline/Tech Stack Snapshot -PM with BA background and experienceRole Summary - (To be filled by Practice /DO)We are seeking a PM and Business Analyst with requirements gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating bu

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Full-time, Third Party

0 - 0

Associate Director, Biostatistics & AI

Remote

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Today

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

Senior Staff Software Advance Quality Engineer

Remote or Detroit, Michigan

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Today

Work Flexibility: Remote or Hybrid or Onsite It's Time to Join Stryker! Why Join Us In this role, you will help shape software quality practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate quality, compliance, security, and risk management into development while establishing scalable processes that support innovation and efficient delivery. Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our

Full-time

USD 102,600.00 - 171,000.00 per year

Lead Data Manager/SAS programmer (Job 1425)

Remote

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Today

About Us DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. Our experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike by leveraging advanced tools - including digital transformation, artificial intelligence, data analytics, cloud enablement, modeling, and sim

Full-time

USD 130,000.00 - 175,000.00 per year

Computer Systems Validation Engineer

Remote

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Today

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

Full-time

USD 150,000.00 - 178,000.00 per year

Business Analyst, AI & Enterprise Data Products with Pharma domain exp + Google Cloud Platform environment exp

Remote

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10d ago

Business Analyst, AI & Enterprise Data Products with Pharma domain exp + Google Cloud Platform environment exp Duration: 12+ Months Location: Remote Work Authorization: USC Position Summary We are seeking a Business Analyst to define requirements for an AI-driven application serving internal business functions across Quality / Manufacturing / Clinical / Regulatory / Commercial. The application sits on top of a substantial data layer, drawing from multiple enterprise source systems, and uses m

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Contract

60 - 65

Lead Software Platform Engineer, MLOps

Remote

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Today

Who We Are TetraScience is the Scientific Data and AI Cloud company. We are catalyzing the Scientific AI revolution by designing and industrializing AI-native scientific data sets, which we bring to life in a growing suite of next gen lab data management solutions, scientific use cases, and AI-enabled outcomes. TetraScience is the category leader in this vital new market, generating more revenue than all other companies in the aggregate. In the last year alone, the world's dominant players in

Full-time

USD 200,000.00 - 270,000.00 per year

SAP Delivery Manager (ERP) Life Sciences

Remote

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28d ago

SAP Delivery Manager (ERP) Life Sciences Devfi, Inc. 100% remote Salary: DOE About Devfi Devfi, Inc is an SAP services partner to life sciences and pharmaceutical companies. We deliver S/4HANA implementations for global pharma manufacturers, CDMOs, biotech and medical device clients across the Globe. Our clients operate under FDA, EMA and MHRA,GxP oversight. Every system we touch is validated and every change is auditable that standard is why they choose a specialist partner over a generalist.

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Contract

Depends on Experience

Senior Data Manager/REDCap Programmer (Job 1423)

Remote

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Today

Full-time

USD 110,000.00 - 140,000.00 per year

21 cfr part 11 jobs in Bend, OR, USA