FDA Jobs in Chicago, IL

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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 moments 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 19 days ago | Updated moments 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 26 days ago | Updated 26 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 19 days ago

Validation Experience with SAP

iTvorks Inc

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Chicago, Illinois, USA

Contract

Overview of SAP Validation ExperienceValidation experience with SAP typically refers to hands-on involvement in validating SAP systems, configurations, and customizations to ensure they meet business requirements and regulatory standards. Key Areas of SAP Validation Experience1. Validation MethodologyExperience with GxP validation (for life sciences/pharma) Knowledge of FDA 21 CFR Part 11, EU Annex 11, or other relevant regulations Understanding of validation lifecycle (V-Model, Agile validation
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Posted 1 hour ago

JDE Developer

VC5 Consulting

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Bolingbrook, Illinois, USA

Contract

JDE Developer Contract-to-Hire Hybrid (Bolingbrook, IL) We are seeking a skilled JD Edwards Developer to join a high-impact internal applications team supporting a leading engineer-to-order manufacturer. This is a hybrid contract-to-hire role where youll work closely with business and IT leadership to modernize, integrate, and optimize the JDE EnterpriseOne 9.2 environment. Youll translate business requirements into actionable solutions, lead development efforts, and bring your expertise in Or
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Posted 21 days ago | Updated 3 days ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Schaumburg, Illinois, USA

Full-time

Responsibilities: Strong understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11 and other relevant regulations). Bachelor's degree or equivalent experience in computer science, information technology, or a related field. High degree of proficiency in Microsoft Office Suite and Smartsheet. Detail-oriented with a strong analytical mindset and problem-solving capabilities. Excellent project
Posted 47 days ago | Updated 8 hours ago

Director, Automation Engineering

Flextronics

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Buffalo Grove, Illinois, USA

Full-time

Job Posting Start Date 06-25-2025 Job Posting End Date 08-29-2025 Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraord
Posted 1 day ago | Updated 8 hours ago

Principal AI/ML Engineer

Abbott Laboratories

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Chicago, Illinois, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'
Posted 30 days ago | Updated 5 hours ago

Senior Human Factors Engineer

Medline Industries, LP

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Northfield, Illinois, USA

Full-time

Job Summary This position is responsible for leading and conducting Human Factor/Usability activities to ensure medical devices (Class I and Class II) are safe to use in various user environments. This engineer will collaborate with design engineers and divisional teams to improve the product designs (New and existing), specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for misuse and/or use errors. The eng
Posted 7 days ago | Updated 5 hours ago

Engineer II, Systems

ICU Medical, Inc.

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Lake Forest, Illinois, USA

Full-time

Job Description Position Summary The Systems Engineer II will make an immediate impact defining ICU Medical's current and next generation infusion pumps to meet user and stakeholder needs with guidance from more experienced engineers and managers. The successful candidate will have the following traits: Experienced in System Engineering techniques Experienced in the development and maintenance of life supporting medical products Able to work independently with minimal supervision Able to col
Posted 26 days ago | Updated 8 hours ago

Manager, Quality and Validation

Abbott Laboratories

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Lake Forest, Illinois, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Manager, Quality and Validation Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be yo
Posted 5 hours ago

Senior Manager, Third Party Manufacturing

Abbott Laboratories

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Buffalo Grove, Illinois, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Sr. Manager, Third Party Manufacturing Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your famil
Posted 60+ days ago | Updated 5 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 17 days ago | Updated 14 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 17 days ago | Updated 14 days ago

SAP PTP (Remote)

Vision Square

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Remote

Contract, Third Party

Role- SAP PTP Location- Remote Duration: Long Term Roles & Responsibilities: Lead the design and implementation of SAP PTP processes tailored to pharmaceutical supply chain and distribution operations. Configure SAP MM, including purchasing, inventory management, and invoice verification. Ensure compliance with GxP, FDA 21 CFR Part 11, and other regulatory requirements. Collaborate with stakeholders to gather business requirements and translate them into SAP solutions. Integrate SAP PTP with SA
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Posted 1 hour 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 28 days ago | Updated 4 hours ago

Commercial Quality Manager

Abbott Laboratories

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Des Plaines, Illinois, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life
Posted 60+ days ago | Updated 5 hours 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 14 days ago | Updated 14 days 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 47 days ago | Updated 8 hours ago