fda Jobs in minneapolis, mn

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Senior Regulatory Affairs Specialist

Sunrise Systems, Inc.

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

Senior SAP PP/PM Functional Consultant (Manufacturing & Maintenance)- LOCAL TO St. Paul, MN

Wise Equation Solutions Inc.

Saint Paul, Minnesota, USA

Contract

Job Title: Senior SAP PP/PM Functional Consultant (Manufacturing & Maintenance) Location: St. Paul, MN- 2-3 days in a week Onsite 12+ Months Contract Experience: 10+ years Job Summary Seeking a highly experienced SAP PP/PM implementation specialist with deep domain expertise in pharmaceutical manufacturing and equipment maintenance. The consultant will lead comprehensive manufacturing implementations, bringing extensive knowledge of production planning, quality integration, and maintenance strat

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

US

Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Design/Build Solutions to meet our Clients

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

US

Full-time

Sr Mechanical/Process Design Engineer - Technical Lead (Cleanrooms/Pharma/Healthcare/cGMP) - Remote (East Coast Preferred) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Des

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

US

Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Design/Build Solutions to meet our Clients

SAP PP/PM Consultant

Innova Solutions, Inc

Saint Paul, Minnesota, USA

Contract

Innova Solutions is immediately hiring for a SAP PP/PM Consultant. Position type: Full-time Contract Duration: 6+ Months Location: St. Paul, MN 55144 (Hybrid Role- 3 days in office) As a(n) SAP PP/PM Consultant, you will: Experience: 10+ years Job Summary: Seeking a highly experienced SAP PP/PM implementation specialist with deep domain expertise in pharmaceutical manufacturing and equipment maintenance.The consultant will lead comprehensive manufacturing implementations, bringing extensive kno

Business Analyst

NTT DATA Americas, Inc

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) wil

LIMS and QC Applications Consultant

Expedite Technology Solutions

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

Principal Engineer - Disposables R&D, Sustaining

Katalyst Healthcares and Lifesciences

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. Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets. Manage change controls from initiation through execution. Lead the creation and maintenance of design history files. Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders. Sche

Engineer Disposables and Sustaining

Katalyst Healthcares and Lifesciences

Plymouth, Minnesota, USA

Full-time

Responsibilities: Create new 3rd party supplier documentation including design specifications, labelling, design drawings, etc. for peritoneal dialysis disposable sets. Create, modify, and maintain design history files. Perform change control assessments. Work closely with project manager and technical lead to achieve project commitments. Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. Requirements:

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

Minneapolis, Minnesota, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures, and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.

R&D Engineer Sustaining, Medical Devices (Disposables) - Plymouth, MN

Cube Hub, Inc.

Plymouth, Minnesota, USA

Contract

Job Title: Principal R&D Engineer Sustaining, Medical Devices (Disposables) **Workers can be remote/hybrid but must be local and able to come into the office at least three days a week** Job Location: Plymouth, MN Job Duration: 12 months Summary: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure within sustaining engineering for disposable medical devices. Essential Duties and Responsibilities: This section contains a list of prima

Principal Engineer

Katalyst Healthcares and Lifesciences

Plymouth, Minnesota, USA

Full-time

Job Description: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure within sustaining engineering for disposable medical devices. 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. Manage a new 3rd-party supplier documentation strategy for peritoneal dialysis disposable sets. Manage change controls from init

SAP PP/MM Consultant

Gov Services Hub

Saint Paul, Minnesota, USA

Contract

Job Overview: Seeking a highly experienced SAP PP/PM implementation specialist with deep domain expertise in pharmaceutical manufacturing and equipment maintenance. The consultant will lead comprehensive manufacturing implementations, bringing extensive knowledge of production planning, quality integration, and maintenance strategies in validated environments. RequirementsSAP Implementation Experience: ? 10+ years of comprehensive SAP PP/PM implementation experience with minimum 5 full lifecycle

SAP PP/PM Functional Consultant

Techgene Solutions LLC

West Saint Paul, Minnesota, USA

Full-time, Part-time, Contract, Third Party

SAP PP/PM Functional Consultant Onsite from Day 1 in St. Paul, MN. (will consider works who can relocate and work onsite from Day1) Duration: 6 months+ Ideally Pharma healthcare experience. Required Skills & Experience: SAP Implementation Experience: 10+ years of comprehensive SAP PP/PM implementation experience with minimum 5 full lifecycle manufacturing projects Proven track record of leading complex manufacturing implementations in process and discrete industries Deep technical expertise i

Quality Engineer

Judge Group, Inc.

Eagan, Minnesota, USA

Contract

Location: Eagan, MN Salary: $35.00 USD Hourly - $40.00 USD Hourly Description: Job Title: Quality Engineer Location: Hybrid in Eagan, MN Employment Type: Contract to Hire About the Role: Our client is seeking a detail-oriented and proactive Quality Engineer to join our team. This role supports cross-functional departments including Quality, Regulatory, Engineering, Manufacturing, Sales, Marketing, Accounting, and Customer Service. The Quality Engineer will be responsible for managing compla

Senior SAP PP/PM Functional Consultant -( Healthcare MANUFACTURING & MAINTENANCE)

Wise Equation Solutions Inc.

Saint Paul, Minnesota, USA

Contract

SAP MAKE DOMAIN CONSULTANT - MANUFACTURING & MAINTENANCE Job Title: Senior SAP PP/PM Functional Consultant (Manufacturing & Maintenance) Location: Twin Cities, USA (Hybrid) Experience: 10+ years Required Skills & Experience: SAP Implementation Experience: 10+ years of comprehensive SAP PP/PM implementation experience with minimum 5 full lifecycle manufacturing projectsProven track record of leading complex manufacturing implementations in process and discrete industriesDeep technical expertise i

Engineer Disposables R&D, Sustaining

Stefanini

Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) For quick Apply, please reach out to Vipul Bhardwaj - call: / email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN (Hybrid) Shift: 1st Shift Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets.Create, modify, and maintain design history files.Perform change control assessments.

Principal Engineer Disposables R&D, Sustaining

Stefanini

Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Principal Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) For quick Apply, please reach out to Tuhin Podder- call: /email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN (Hybrid) Shift: 1st Shift Technical lead for DHF structure within sustaining engineering for disposable medical devices.Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.Manage change controls from initiation th

Senior SAP MM/WM Functional Consultant (Master Data & Inventory)

RMSS INC

Minneapolis, Minnesota, USA

Contract

Job Summary: We are seeking multiple (4-6) seasoned SAP MM/WM implementation specialist with deep domain expertise in master data governance and inventory management for manufacturing in the Medical Equipment / Healthcare industry . The consultant will be responsible for comprehensive SAP implementations focusing on material master data, inventory optimization, and warehouse management in regulated environments. Key Responsibilities: Lead the SAP MM/WM/EWM implementation projects from requiremen