GXP Jobs in Wisconsin

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compliance lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 1 hour ago

Senior Business & Program Management Consultant (32660)

Myticas LLC

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Remote or Chicago, Illinois, USA

Contract

Senior Business & Program Management Consultant (GxP/Clinical) Location: Waukegan, IL (3 days onsite) Company: Myticas's direct client based in North Chicago, IL MUST Have: 8-10 years of Senior IT project experience: System Lifecycle (SLC) Expertise. GXP system experience required - GXP system implementation including custom development and validated systems. Portfolio / Program management experience. Clinical Systems Project financial management, and vendor management expertise. Description:
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Posted 5 hours ago

IBM DOORS Developer - Milwaukee, WI (ONSITE)

ASCII Group LLC

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Milwaukee, Wisconsin, USA

Third Party, Contract

The following requirement is open with our client. Client : TCSTitle : IBM DOORS DeveloperLocation : Milwaukee, WI (ONSITE)Duration : 12+ MonthsRate : OpenVisa Status : H1B Relevant Experience (in Yrs.) : 10+ Job Description:Analyze existing DOORS modules, attributes, and DXL scripts to assess migration plan Design and implement Python-based tool to extract, transform, and load data into Jama.knowledge on Jamas REST API or Req IF format to automate data import and validation.Collaborate with st
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Posted 7 days ago | Updated 4 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 31 days ago | Updated 8 hours ago

Veeva Presales Consultant

NexInfo Solutions, Inc.

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Remote

Contract

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content
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Posted 30 days ago | Updated 1 hour ago

Lead Agile Coach

Intento Analytics LLC

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Remote

Contract

Skills required: Agile, Lead, Certification , GXP, compliance and Audit , Jira and Pharma industry Required Qualifications SAFe Certified professional with deep expertise in Apptio TargetProcess, Jira, and scaled agile delivery frameworks . Demonstrated knowledge of GxP-regulated projects in the pharmaceutical industry, ensuring compliance and audit readiness during Agile delivery. Skilled in the development and management of Objectives and Key Results (OKRs) to align program delivery with st
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Posted 2 days ago

Lead Agile Coach

Intento Analytics LLC

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Remote

Contract

Job Title : Lead Agile Coach Location: 100% Remote Work Authorization: (H1B/ EAD/L2 EAD/EAD/OPT) Skills required: Agile, Lead, Certification , GXP, Compliance and Audit , Jira and Pharma industry Required Qualifications SAFe Certified professional with deep expertise in Apptio TargetProcess, Jira, and scaled agile delivery frameworks . Demonstrated knowledge of GxP-regulated projects in the pharmaceutical industry, ensuring compliance and audit readiness during Agile delivery. Skilled in the d
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Posted 2 days ago

SAP Project Manager-Bio-Pharma

NexInfo Solutions, Inc.

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Remote

Contract, Third Party

About Nexinfo: NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges
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Posted 2 days ago

Global IT Compliance Sr Specialist

Thermo Fisher Scientific

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Pennsylvania, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 18 days ago | Updated 8 hours ago

Assoc. Director, PV Systems Reporting & Analytics

Sunrise Systems, Inc.

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Remote

Contract

Position Title: Assoc. Director, PV Systems Reporting & Analytics Job ID: 25-09090 Location: Remote Duration: 05 months on W2 Contract Top skills: Argus Safety application and drug safety domain knowledge, Computer Systems Validation & SDLC experienceStrong matrix management skills OBJECTIVE: Oversee and support tools used for the reporting and interactive analysis of data from the global pharmacovigilance (PV) databaseProvide technical and strategic input into the roadmap, planning, and imple
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Posted 23 days ago | Updated 1 hour ago

Manager, IT/Senior Systems Analyst

Thermo Fisher Scientific

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Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Manager, IT/Senior Systems Analyst HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Support Thermo Fisher's integration of Tracelink (Track and Trace Solution) and Thermo Fisher's downstream partners to ensure Thermo Fisher is compliant with Serialization and Track and Trace requirements and detailing the technical
Posted 33 days ago | Updated 8 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 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) wil
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Posted 7 days ago | Updated moments ago

Senior Director, Head of Research Systems Engineering

Johnson & Johnson

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Remote or Pennsylvania, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 12 days ago | Updated 8 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: 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 responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 30 days ago | Updated 8 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 21 days ago | Updated 8 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 60+ days ago | Updated 8 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 60+ days ago | Updated 8 hours ago

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

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Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical
Posted 41 days ago | Updated 8 hours ago

Principal Software Engineer

Amgen Inc

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Remote or Thousand Oaks, California, USA

Full-time

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pati
Posted 13 days ago | Updated 8 hours ago