fda Jobs in minnesota

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Senior Regulatory Affairs Specialist

Sunrise Systems, Inc.

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Chaska, Minnesota, USA

Contract

Our client, a leading medical devices manufacturing company, is looking for a Senior Regulatory Affairs Specialist. This is for an initial duration of 18 months and is located in Chaska, MN. Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship) 3 must haves: Experience with design changes, demonstrated RA leadership on high visibility core team, IVDR or EMDR experience Job Description: The Senior Specialist Regulatory Affairs is an individual contributor and subject
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Posted 3 days ago | Updated 1 day ago

Sr. Engineer - Disposables R&D, Sustaining (Hybrid)

DivIHN Integration Inc.

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Plymouth, Minnesota, USA

Contract

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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Posted 1 day ago | Updated 3 hours 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 60+ days ago | Updated 6 hours ago

Business Analyst

NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE) Job Description: Experience Level: 7 9 years of relevant experience Role Overview: The Business Analyst (BA) w
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Posted 16 days ago | Updated 6 hours ago

Senior Full Stack Engineer (.NET 8 / Angular / Azure)-- Minneapolis, MN- Hybrid (3 days in Office + 2 days from WFH)-Medical Device exp. is must

cyberThink, Inc.

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Minneapolis, Minnesota, USA

Contract, Third Party

About the Role: We are looking for a Senior Full Stack Engineer with proven experience in modern web development using Angular (v14+), .NET 8, and Cosmos DB with Azure cloud ecosystems. You will be working on a connected medical device platform that collects therapy data and transmits it to an Azure-based cloud portal. This platform plays a vital role in improving patient care and helping clinicians and administrative teams manage healthcare delivery more effectively. This role is ideal for some
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Posted 12 days ago | Updated 12 days ago

PTC Arena Consultant

Teknikoz

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Remote

Contract, Third Party

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an
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Posted 23 days ago | Updated 23 days ago

Lead Engineer MES OpCenter

New York Technology Partners

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Remote

Contract

Job Title: Lead Engineer MES OpCenter Location: 100% Remote Experience: 12+ Years JD: Lead Engineer MES OpCenter 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 responsibility for leading resources contracted via a third-party and through other J&J organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. The Lead Engineer will b
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Posted 17 days ago

Technical Writer

Oxford Global Resources

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Remote

Contract

Tech Writer 100% Remote, PST Working Hours 3+ months Oxford s client is seeking an experienced Tech Writer to join our dynamic team. This role will be responsible for developing and managing all aspects of documentation for the regulated projects. The ideal candidate must exhibit good documentation practice understanding and implementation. Client uses a mix of both paper-based (Word Doc with DocuSign) and eDocs (mentioned Confluence). Ideally the candidate will be experienced with both. Require
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Posted 2 days ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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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 45 days ago | Updated 12 hours ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract, remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Active
Posted 15 days ago | Updated 11 days ago

Delta V Automation Engineer

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Delta V Automation Engineer to join a growing leader in the pharmaceutical/biotechnology space for a contract , remote position. The Delta V Automation Engineer will oversee DeltaV DCS automation systems in a cGMP pharmaceutical environment, managing system integration, documentation review, and cross-functional coordination while ensuring compliance with FDA regulations and validation requirements. Responsibilities of the Delta V Automation Engineer include: Acti
Posted 15 days ago | Updated 11 days ago

SAP Plant Maintenance Consultant

IT Resonance Inc.

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Remote

Third Party, Contract

Hi, Here is an Remote Contract Job opportunity for below position. Role: SAP Plant Maintenance (PM) Consultant Location: IL, Remote + (Occasional Travel) Contract Duration: 12+ Months Experience: 10 + Year skills SAP Plant Maintenance (PM) and compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards, Nirmal Kumar Phone:- Email:-
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Posted 60+ days ago | Updated 1 day ago

Validation Engineer III

Katalyst Healthcares and Lifesciences

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Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot
Posted 45 days ago | Updated 12 hours ago

Drug Safety Scientist

Sunrise Systems, Inc.

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Remote

Contract

Job Title Drug Safety Scientist Job ID: 25-08470 Location: 100% Remote (Candidates should be in EST only) Duration: 12 months on W2 Contract Summary: Seeking an experienced Drug Safety Scientist with 5+ years in pharmacovigilance to support regulatory safety reporting and risk management. Must hold a Bachelor's/Master s in Pharmacy, Biotechnology, or Chemistry. Key Responsibilities: Author safety reports (DSUR, PBRER, PADER)Support signal detection and safety data evaluationConduct literature
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Posted 26 days ago | Updated 1 day ago

DeltaV Automation Engineer - Pharmaceuticals

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is hiring a DeltaV Automation Engineer for a growing BioPharma company located in Holly Springs, NC. The DeltaV Automation Engineer will be responsible for designing, developing, and maintaining automation systems for pharmaceutical manufacturing processes. This role requires expertise in Emerson DeltaV DCS (Distributed Control System), with a focus on process optimization, validation, and compliance with industry regulations. The DeltaV Automation Engineer can work remote, but w
Posted 12 days ago | Updated 11 days ago

Packaging Operations Manager, High-Speed Food Manufacturing

Hire Horizons

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Winona, Minnesota, USA

Full-time

Job DescriptionWe are seeking an ambitious mechanically-inclined Food industry Operations professional with experience producing and packaging bulk food ingredients, animal feed, or dry powdered products. As the Packaging Operations Manager you will be responsible for leading the safe material handling, product blending, packaging, and warehouse logistics of all dry finished goods in a high-speed manufacturing environment. You will also ensure adherence to all safety programs and help drive cont
Posted 10 days ago | Updated 20 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 45 days ago | Updated 12 hours ago

Principal Software Quality Engineer

Primary Talent Partners

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Mounds View, Minnesota, USA

Contract

Primary Talent Partners has an open 12 month W2 contract with a large medical device client of ours in the Mounds View, MN area.Pay Range: $80.00 to $90.00 per hour (No PTO, benefits, etc but self funded ACA-compliant healthcare plan available to opt-in to) Position OverviewThis role involves a leadership position in software quality engineering, focusing on driving quality into software solutions for cardiac imaging and transcatheter heart valve implantation applications. The candidate will w
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Posted 3 days ago | Updated 2 days ago

Oracle Field Service Cloud Consultant

Prutech Solutions

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Remote

Contract

Job Title: Oracle Field Service Cloud Consultant Duration: Full Time / Contract Location : Remote Required Skills/Experience: Bachelors degree in computer science, Information Technology, Engineering, or a related field.5+ years of experience in implementing and supporting Oracle's Field Service solutions.Strong understanding of and field service processes and best practices.Proven expertise in Oracle's E-Business Suite, Cloud, or other relevant Oracle products.Excellent analytical and problem-
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Posted 60+ days ago | Updated 22 days ago

Sr. Engineer Disposables R&D, Sustaining

Katalyst Healthcares and Lifesciences

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Plymouth, Minnesota, USA

Full-time

Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (e.g. new features, suppliers, materials, labeling, CAPA/Client, cost reduction, remediation). Identify, investigate, and solve engineering problems utilizing risk-based and customer focused app
Posted 43 days ago | Updated 12 hours ago