21 CFR Part 11 Jobs in Minneapolis, MN

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Validation Engineer

Katalyst Healthcares and Lifesciences

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Maple Grove, Minnesota, USA

Full-time

Responsibilities: Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures. Provide project estimates independently. Review estimates for Engineer I's. Submit specification, protocol and report for approvals and documentation control vi Change Request. Develop
Posted 3 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Maple Grove, Minnesota, USA

Full-time

Responsibilities: To ensure the quality of our client's software applications and equipment by validating/qualifying to specifications. Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations. Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCAD pplications, and system
Posted 3 days ago | Updated 3 hours ago

Manufacturing Engineer

Trelleborg Group

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Delano, Minnesota, USA

Full-time

Trelleborg Healthcare and Medical is seeking a Manufacturing Engineer to join their team. The Production Supervisor is responsible for on time, first pass yield of product to customer at customers' specification. Manages all resources to achieve this responsibility and provides leadership necessary to grow and develop staff for success. Addresses failures to meet this responsibility and implements remedies, within Company guidelines, to assure these failures do not repeat. Responsible for contin
Posted 23 hours ago

Software Quality Engineer III

Boston Scientific Corporation

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Maple Grove, Minnesota, USA

Full-time

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your
Posted 30 days ago | Updated 3 hours 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 3 days ago | Updated 3 hours ago

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 1 day 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 3 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 24 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 12 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 39 days ago | Updated moments 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 5 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 19 hours 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 5 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