GXP jobs in Chicago, IL

Remote

•

8d ago

Primary & Secondary Skill P :GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain. JD (Detailed) 15+ yearsof software QA/testing experience, with at least10+ yearsin regulated environments like life sciences, pharma, healthcare. Strong expertise inGxP compliance,CSV, andFDA 21 CFR Part 11standards. Strong leadership, test planning, estimation, and cross-functional communication skills. Experience in testingSAAS/COTS/Bespoke,CRM,Life sciences systems, orlab systems(e.g.,St

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Contract

60 - 65

GxP Lab Computing Engineer

Chicago, Illinois

•

Today

Required Skills: Excellent customer service skills complemented by an ability to listen to and interpret client requests Ability to troubleshoot complex instrument and technology issues Strong oral and written communication skills Ability to identify, track and complete tasks for multiple projects Knowledge of laboratory safety practices as defined by the company and/or customer's site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsib

Full-time

GMP & GxP Business Analyst

Remote

•

4d ago

GMP & GxP Business AnalystLocation: RemoteDuration: Long Term Roles & ResponsibilitiesGather, analyze, and document business and user requirements across functional teams.Act as the primary liaison between Business, IT, end users, and cross-functional stakeholders during project execution and maintenance phases.Analyze business challenges and support evaluation of appropriate IT solutions.Collaborate with managers and end users to ensure alignment and buy-in for proposed solutions.Develop detail

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Contract

Depends on Experience

Technical Writer - Pharma IT Compliance

Remote

•

12d ago

Position Summary - The Technical Writer will be responsible for developing, maintaining, and improving IT process documentation within a regulated pharmaceutical (GxP) environment. This role involves authoring and managing key compliance documents, supporting infrastructure qualification activities, and ensuring alignment with global IT standards and QA expectations. The individual will work closely with project teams, IT compliance, and global shared services to ensure adherence to regulatory

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Contract, Third Party

Depends on Experience

SAP PPQM PTS Consultant Remote

Remote or Atlanta, Georgia

•

Yesterday

Job Id: #CGEMJP00321513 Title: SAP PPQM PTS Consultant Location: Remote Duration: 12+ Months Position Summary: Job Role and Responsibilities: We are looking for a highly skilled Senior SAP PPQM Consultant with over 6 years of experience in SAP Production Planning (PP) and Quality Management (QM) modules, specifically within the pharmaceutical industry. The ideal candidate will have a deep understanding of GxP compliance, regulatory requirements, and validation documentation. This role involv

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

CSA Auditor, TraceLink

Remote

•

11d ago

We are seeking a Computerized System Assurance (CSA) Auditor with deep experience in TraceLink and GxP-regulated environments to ensure the compliance, validation, and lifecycle integrity of computerized systems supporting serialization, traceability, and supply chain management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory expectations for data integrity and system validation. Key Responsibilities: Plan, conduct, and report CSA aud

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Contract

85 - 90

Veeva Vault Solution Architect

Remote

•

17d ago

Title: Veeva Vault Solution ArchitectLocation: New Jersey (Remote) Job Description -This role will be responsible for developing and maintaining solution architecture, system administration, security, and procedures across the Veeva Vault Platform.Support all assigned development activities for the Veeva Vault implementation program under the leadership of the client Quality Veeva team.Coordinate with Business analysts to outline the business requirements and ensure IT security and Data Integrit

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Contract

Depends on Experience

SAP PPDS Consultant_REMOTE

Remote or Hybrid in Indiana

•

Yesterday

Job title: SAP PPDS Consultant Work Location: 893 S Delaware St Indianapolis, 46225 REMOTE Contract_W2 Minimum years of experience: 12 + Detailed Job Description: .This position requires an expert contributing to different phases of the consulting lifecycle. You will be intensely involved in business process consulting; you will define the problem, propose and create the solution. You will also play an important role in the development, configuration and deployment of the overall solution. You

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Contract

Depends on Experience

Lead SAP S/4HANA PP/DS Consultant

Remote

•

Yesterday

We are seeking a highly experienced Lead SAP S/4HANA PP/DS Consultant to drive business process consulting, solution design, configuration, and implementation within a regulated pharmaceutical environment. This role demands strong leadership, client-facing capabilities, and deep expertise in PP/DS, including both APO PPDS and S/4HANA PP/DS. You will be responsible for guiding teams across the consulting lifecycle, supporting blueprinting, design workshops, testing, deployments, and business enab

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Third Party, Contract

Depends on Experience

MES Engineer

Remote or Needham, Massachusetts

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12d ago

Title: MES Technical Consultant Regulatory Relevance: GxP The Role: The MES Technical Consultant will serve a key role owning the development and validation of core MES recipe objects and accompanying integrations. Additionally, this individual will also be well versed in Infobatch report development, web development, SQL, ISA S-95 standards will be act as an escalation point contact for the MES, Infobatch and ODH teams for complex initiatives. Key Responsibilities: Lead the design, development,

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Full-time, Third Party

$60 - $70

LIMS Developer

Remote

•

3d ago

Role: LIMS Developer Location: Remote Role Overview Design, configure, and maintain LIMS (version 12.3) solutions Customize workflows and integrate LIMS with enterprise systems Ensure compliance with laboratory and business processes Required Skills Strong knowledge of LIMS v12.3 architecture (web client and database configurations) Proficiency in C#, .NET Framework, and SQL Server Experience with web services integration (SOAP/XML) Familiarity with laboratory workflows and regulatory complian

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Third Party, Contract

60 - 60

Salesforce Solution Architect

Remote

•

17d ago

Job Title: Solution Architect Salesforce & Honeywell TrackWise Digital Location: Remote Experience: 10+ Years Position Overview: We are seeking an experienced Solution Architect with strong expertise in Honeywell s TrackWise Digital platform to lead architecture, design, and integration for digital quality systems. The ideal candidate will drive end-to-end solution design and ensure seamless alignment between Salesforce, TrackWise Digital, and enterprise applications. Key Responsibilities: Solu

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Contract

Depends on Experience

SAP Test Automation Delivery Lead

Remote or Hybrid in California

•

Today

Job Title: SAP QA Automation ( Tosca ) Lead Duration: 18 Months+ Location PST - 100% Remote Exp. Level: 10+ years Job Description Our client is looking for a TOSCA certified automation engineer who has experience to Lead automation strategy and delivery across SAP implementation projects, ensuring consistency and compliance (GxP, FDA). Client is looking for Pharma / BioTech domain in background. Key Responsibilities: Lead automation strategy and delivery across SAP implementation projects, ensu

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Full-time, Contract

BASED ON EXPERIENCE

Solution Architect Veeva Platform

Remote

•

3d ago

Role: Solution Architect Veeva Platform Location: Remote USA Type; W2 Contract Required Skill: QMS Veeva Job Description: This role will be responsible for developing and maintaining solution architecture, system administration, security, and procedures across the Veeva Vault Platform. - Support all assigned development activities for the Veeva Vault implementation program under the leadership of the client Quality Veeva team. - Coordinate with Business analysts to outline the business requireme

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Contract

$80 - $100

Veeva Vault Solution Architect

Remote

•

17d ago

Job Title: Veeva Vault Solution ArchitectLocation: US Remote (Must Work in EST Hours)Rate: $90/hr (to vendor) Job Description: We are seeking an experienced Veeva Vault Solution Architect to design, implement, and maintain scalable, compliant solutions within the Veeva Vault Platform. The ideal candidate will have hands-on expertise in Veeva Vault Quality (QMS), system configuration, custom development, and integration management across enterprise systems. Key Responsibilities: Develop and maint

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Contract

$90+

Computer System Validation - CSV Engineer

Remote or New Jersey

•

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

Sr. IT Program Manager

Remote or Massachusetts

•

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

Statistical Software Configuration Specialist (Statistica TIBCO)

Remote or Hybrid in Vacaville, California

•

Yesterday

Statistical Software Configuration Specialist (Statistica TIBCO) Vacaville, CA / A hybrid model (once or twice in the office) / Remote Duration: - 6-12 Months+ For a "Statistica Software configuration specialist" role, which likely involves both data analytics and potentially on-site manufacturing support or collaboration, a hybrid model (once or twice in the office) is a probable arrangement. Statistical Software Configuration Specialist (Statistica TIBCO) Position Overview The Statistical Soft

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Contract, Third Party

Depends on Experience

Lead Cloud Architect

Remote or Richmond, Virginia

•

Today

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patien

Full-time

USD 143,300.00 - 238,800.00 per year

Associate Director, Regulatory Data Governance Lead

Remote or Massachusetts

•

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 Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Summary: The Regulatory Data Governance Lead will ensure Regulatory information and data standards are aligned with Takeda's strateg

Full-time

USD 153,600.00 - 241,340.00 per year

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GXP jobs in Chicago, IL, USA