21 CFR Part 11 jobs in Minneapolis, MN

Remote

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Today

We are seeking a Senior IT Project Manager with demonstrated experience leading complex, cross-functional technology initiatives in global and regulated manufacturing environments. The immediate priority for this role will be the delivery of projects involving Manufacturing Execution Systems, with a primary focus on the Critical Manufacturing MES platform. The successful candidate should also bring experience that can be applied across adjacent enterprise technology domains, such as SAP/ERP,

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Contract

60 - 65

Manufacturing Data Strategy & Architecture Consultant

Remote

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3d 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

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Full-time, Third Party

Depends on Experience

CSV Validation Engineer

Plymouth, Minnesota

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5d ago

Summary: We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN. Roles & Responsibilities: Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports. Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports. Perform risk assessments, impact assessments, traceability, and change control activities. Support validation of GxP-regulated compu

Full-time

Data Operations & R&D Data Management Manager

Little Canada, Minnesota

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Today

Location: Little Canada, Minnesota Type: Contract Job #107005 Job Title: Data Operations & R&D Data Management Manager Contract Duration: 1 year, possible extension Location: Little Canada, MN Work Arrangement: Onsite Summary To accelerate innovation, we are seeking a Data Operations & R&D Data Management Manager to lead the strategy, processes, and infrastructure that enable secure, scalable, and compliant use of data across the product development lifecycle. This role combines data platform

Full-time

R&D Data Management Manager

Little Canada, Minnesota

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2d ago

DivIHN (pronounced divine) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent. Visit us at to learn more and view our open positions. Please apply o

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Third Party, Contract

$57 - $61

Software Quality Assurance Engineer II - MFG

Eden Prairie, Minnesota

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Today

Starkey is adding a Software Quality Assurance Engineer II at its global headquarters in Eden Prairie, MN. Are you passionate about quality, compliance, and making a difference in others lives? Do you have 5 years of software development or quality assurance with knowledge of IEC 62304 and ISO 13485? If so we would love to hear from you. This position is responsible to ensure the quality of the software/firmware used in the Starkey products and adherence to the software quality assurance standar

Full-time

USD 78,540.00 - 107,000.00 per year

Project Manager – MES

Remote

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13d ago

8+ years of IT Project Management experience leading medium-to-large global implementations, upgrades, and transformation projects.Manufacturing Execution Systems (MES) experience is required, preferably Critical Manufacturing, with experience in MES deployments, rollouts, upgrades, integrations, or multi-site initiatives.Strong experience managing cross-functional global teams, project plans, budgets, resources, RAID logs, risks, issues, dependencies, and executive reporting.Experience in regul

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Full-time

50 - 60

Werum PAS-X MES Lead / Solution Consultant

Remote

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15d ago

Werum PAS-X MES Lead / Solution Consultant Location: Remote Duration: 9-12 month JD Skills- Werum PAS-X v3.18 or above MES, IOT,L2 systems 8-12 years of overall experience in Pharmaceutical Manufacturing, MES and other Digital Manufacturing solutions.Minimum 6+ years of hands-on experience in Werum PAS-X MES implementations, MBR designing,rollout and support.Strong experience in Pharma and Life Sciences manufacturing environments.Experience in global rollouts, MES deployments, upgrades, and go

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Contract

Depends on Experience

Pharma MES Scrum Master-Remote

Remote

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Today

The strongest candidates will not be generic Scrum Masters they should have GMP/pharma manufacturing + MES + SAFe/Agile delivery experience. Required Experience & Capabilities Core Role Experience Minimum 3 5 years of experience as a Scrum Master or agile delivery lead in pharmaceutical manufacturing, biotech, or a GMP-regulated life-sciences setting.Hands-on agile delivery experience, including backlog management, sprint facilitation, impediment resolution, and team-level delivery reporting.Dem

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Contract

Depends on Experience

Senior Consultant - GxP & Clinical Quality Assurance

Remote

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9d 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

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Contract, Third Party

$70 - $75

Sr Mngr, Full Stack Clinical Platform Engineer

Remote or Almont, Colorado

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Today

Description: Remote Our client seeks a Full Stack Clinical Platform Engineer to design, implement, and operate production-grade Generative AI and Machine Learning solutions that support Global Development Digital Transformation. The role sits at the intersection of data engineering and applied AI. It partners with Clinical Operations, Data Management, Regulatory, and IT to build and maintain modern data platforms and AI-enabled pipelines that underpin the transformation program. The position r

Contract

Associate Director, RBQM Data Enablement and Analytics

Remote or Massachusetts

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Today

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Accountabilities: Configure Centralized Monitoring platform, including DQA, QTLs and KRIs, to identify and manage critical study risk

Full-time

USD 154,400.00 - 242,550.00 per year

MES/Automation Engineer II/III

Remote or Almont, Colorado

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Today

Description: Remote Eliassen Group seeks an MES/Automation Engineer II/ to support our client, a genetic medicines biotech, on a 6-month contract. The role will focus on Rockwell PharmaSuite design, implementation, configuration, maintenance support, and validation within GMP manufacturing. The engineer will also support DeltaV, PI, and Ignition systems and will contribute to MES Master Recipe development and long-range automation strategy for clinical and commercial manufacturing. The positio

Contract

Solutions Engineer, Life Sciences

Remote

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12d 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

MES & Industrial Automation Engineer (Remote - United States)

Remote or Minnesota

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Today

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant mat

Full-time

USD 106,000.00 - 145,750.00 per year

Manager, IT Assurance and Compliance-Quality Systems

Remote

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Today

Job Description Position Summary The Manager, IT Assurance and Compliance - Quality Systems is responsible for leading and managing the IT Quality Compliance program, ensuring alignment with corporate and site quality and compliance initiatives. This role oversees the establishment, maintenance, and continuous improvement of global IT assurance and compliance processes, including computer software assurance (CSA), software quality management (SQM), and regulatory compliance (GxP, SOX, and other

Full-time

Senior Software System Engineer

Remote or Mesa, Arizona

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Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 111,100.00 - 185,100.00 per year

Platform Information Security Officer (PISO), Life Sciences Platform

Remote

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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

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

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

21 CFR Part 11 jobs in Minneapolis, MN, USA