GAMP jobs in Libertyville, IL

Round Lake, Illinois

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Today

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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$33

Computer System Validation Engineer 1

Remote

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Today

Title: CSV Engineer 1 Location: Remote About: The CSV Engineer 1 will support Computer System Validation (CSV) activities for GxP-regulated systems. This role involves executing validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and company quality standards. The candidate will work closely with IT, Quality, and Business teams to maintain a validated state of systems. Key Responsibilities Assist in the development and execution of validation documentation, inclu

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Contract

Director - Lab Informatics

Remote

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Today

Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory complianc

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Contract, Third Party

Sr. IT Program Manager

Remote or Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Uncover a remarkable opportunity at Thermo Fisher Scientific Inc. to push global advancements in health, cleanliness, and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team, guiding ambitious IT projects that enhance quality, compliance, and supply chain operations within our Contract Development and Manufacturing Organization (CDMO). Argument Development & Case Creation Collaborate

Full-time

USD 143,000.00 - 214,475.00 per year

Validation Engineer III

Remote or Durham, North Carolina

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Today

Job Description Summary The Validation Engineer , is responsible for authoring, executing and reviewing/approval of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsi

Full-time

USD 89,600.00 - 166,400.00 per year

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

Maintenance Technician II

Round Lake Beach, Illinois

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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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: As a Maintenance Technician II, you will play a key role in ensuring reliable operation of all equipment used in the Galaxy filling process a

Full-time

USD 18.85 - 29.62 per hour

Maintenance Technician II

Round Lake Beach, Illinois

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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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Maintenance Technician II provides a high level of maintenance support for all equipment in the Galaxy filling process at Takeda's Round

Full-time

USD 18.85 - 29.62 per hour

Senior Business Analyst / Business Architect

Deerfield, Illinois

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28d ago

Position Overview Were seeking an experienced Senior Business Analyst/Business Architect to lead requirements gathering and business process design for Microsoft Dynamics 365 and Power Platform implementations. This position requires a seasoned professional who can serve as a trusted advisor to clients while bridging the gap between business needs and technical solutions. Key Responsibilities Client Engagement & Requirements Management Lead client-facing discovery sessions and stakeholder interv

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Full-time

Depends on Experience

Sr. Product Owner / Business Analyst - Northbrook, IL

Northbrook, Illinois

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Today

We have an immediate need for a Senior Product Owner/Business Analyst who is responsible for driving the strategic vision, planning, and execution of key product initiatives. This role blends product ownership with strong business analysis expertise to translate business needs into actionable requirements, optimize value delivery, and ensure alignment between stakeholders, development teams, and organizational goals. Key Responsibilities Product Strategy & Vision Define, articulate, and mainta

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Third Party, Contract

Operation Maintenance Specialist

Round Lake Beach, Illinois

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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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role: This position is heavily focused on supporting day-to-day manufacturing operations through expert troubleshooting, preventive maintenance, an

Full-time

USD 70,000.00 - 110,000.00 per year

Lab Computing Analyst

North Chicago, Illinois

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16d ago

Job Title: Lab Computing AnalystLocation: North Chicago, ILDuration: Long Term Job Description:Excellent customer service skills complemented by an ability to listen to and interpret client requestsAbility to troubleshoot complex instrument and technology issuesStrong oral and written communication skillsAbility to identify, track and complete tasks for multiple projectsKnowledge of laboratory safety practices as defined by the company and/or customer's site safety codeResponsibilitiesAs a Lab C

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Contract

Depends on Experience

Automation Service Engineer, Chicago IL

Vernon Hills, Illinois

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Today

Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human el

Full-time

USD 26.10 - 43.00 per hour

Sr Analyst Business Systems IT

Hybrid in Northbrook, Illinois

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Today

Job Summary Job Description Medline Industries, LP. The Information Services department is seeking a Web Commerce Analyst to join our E-Commerce Technology team. This is an opportunity to be a part of the team responsible for the development and maintenance of medline.com. The business analyst has essential responsibilities that span operations and development of sites in the team's portfolio. Responsibilities Requirement Analysis & Documentation: Gather, analyze, and document business and

Full-time

USD 110,240.00 - 165,360.00 per year

ACH Payments Specialist (Product & Conversions) - W2 Contract

Remote

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Today

We are seeking an experienced ACH / Payments Subject Matter Expert (SME) to serve as a Product Owner for an enterprise-wide payments conversion initiative. The ideal candidate will have deep ACH domain expertise, strong business and product understanding, and proven experience in requirements definition, gap analysis, and payment platform conversions. This role is not production support oriented. The focus is on product ownership, functional leadership, and business alignment to ensure seamless

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Contract

$50 - $65

Associate Director, Site Data Integrity and Computer System Validation Lead

Pleasant Prairie, Wisconsin

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Today

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Full-time

USD 111,000.00 - 178,200.00 per year

Automation Engineer

Lombard, Illinois

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Today

The Digital Manufacturing Systems Engineer plays a key role in the site's digital transformation by designing, developing, and deploying electronic manufacturing records and digital workflows. This role leads integration between manufacturing systems (e.g., Tulip MES, Blue Mountain RAM, LabVantage LIMS) and equipment networks, enabling real-time data capture and compliance. The engineer will also support light PLC/HMI programming to facilitate machine-level connectivity. This cross-functional ro

Full-time

Compensation information provided in the description

AI Engineer / Analyst

Remote or Hybrid in Princeton, New Jersey

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Today

Location: Remote (with occasional on-site meetings, potentially quarterly) Contract Length: 12 Months (initial) Start Date: Ideally early December 2025 About the Role: AmicusRx is seeking an experienced AI Engineer/Analyst to join our team on a contract basis. This role is crucial for building the foundational frameworks and architectural models for our AI initiatives. We are looking for a strategic thinker who can bridge the gap between business needs and technical solutions, focusing on t

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Contract, Third Party

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GAMP jobs in Libertyville, IL, USA