gxp Jobs in morristown, nj

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GxP Business Analyst/Project Manager

Eliassen Group

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Anywhere, US

Contract

Description: **Remote** Our Biotechnology client is looking for a GxP Business Analyst/Project Manager to come on for a long-term contract. This person is needed to help "keep the lights on" with respect to legacy systems that are being used for submissions to meet regulatory requirements across the globe. Regulatory requirements are constantly evolving, and our client has to keep product documentation up to date in order to be in compliance and continue to do business in different countries
Posted 60+ days ago | Updated 8 hours ago

Data Engineer

Comptech Associates Inc

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Raritan, New Jersey, USA

Contract

Job title: Data Engineer Location: Raritan, NJ Duration: 6+ months Type: CON_W2 only NOTE: Pharma domain experience is mandatory.. Job description: Candidates with over 10+ years of experience as Data Engineer.Work closely with data scientists, analysts, and business stakeholders to understand data needsEnsure data quality, governance, and compliance with regulatory standards (e.g., GxP)Proficiency with SQL, Python, Spark, or related toolsExperience with cloud platforms (AWS, Azure, or Google Cl
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Posted 60+ days ago | Updated moments 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

Infrastructure Business Analyst

TEKsystems c/o Allegis Group

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Branchburg, New Jersey, USA

Full-time

Description We are seeking a skilled and motivated Infrastructure Business Analyst to support IT initiatives within a regulated manufacturing environment in Branchburg, NJ. This role is ideal for professionals with a background in business analysis or project coordination, particularly within GMP-compliant pharmaceutical or manufacturing settings. You will play a key role in bridging the gap between IT infrastructure and operational technology (OT), ensuring seamless integration and compliance.
Posted 2 days ago | Updated 2 hours 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 4 days ago | Updated moments ago

IT Project Lead V - LIMS Project Manager

Javen Technologies, Inc

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Remote

Third Party, Contract

Job Title: IT Project Lead V Location: Remote. Duration: 15+ Months (Extendable) Duties: This role will assist with the implementation of a new Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) to be used across the organization starting in 2026. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantageUnderstanding of clinical, research, or diagnostic lab workflowsKnowledge of regulatory requirements (GxP, FDA 21 CFR
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Posted 4 days ago

Integration Specialist - Informatica/AWS

Sanofi

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Morristown, New Jersey, USA

Full-time

Job Title: Integration Specialist - Informatica / AWS Location: Cambridge, MA OR Morristown, NJ About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. At Sanofi, we're committed to providing the next-gen healthcare that patients and customers need. It's about harnessing data insights and leveraging AI responsib
Posted 9 hours ago | Updated 9 hours ago

Senior Business Management Consultant (32660)

Myticas LLC

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Remote or Chicago, Illinois, USA

Contract

Senior Business Management Consultant 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. Portfolio / Program management experience. Project financial management, and vendor management expertise. GXP system experience required - GXP system implementation including custom development and validated systems. Description: Senior Business Management Consultant to
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Posted 3 days ago | Updated 5 hours ago

CRM Solution Architect, Patient Support Services

Sanofi

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Morristown, New Jersey, USA

Full-time

Job Title: CRM Solution Architect, Patient Support Services Location: Cambridge, MA Morristown, NJ (Hybrid 3 days a week) About the Job Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. We are seeking a skilled, hands-on CRM Solution Architect to join our team. As part of the Patient Services Solution Architecture team,
Posted 9 hours ago | Updated 9 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 27 days ago | Updated 1 hour ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

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Remote

Contract, Third Party

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce
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Posted 4 days ago | Updated 1 hour 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 38 days ago | Updated 8 hours ago

Lead, Regulatory Data

Sanofi U.S.

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Morristown, New Jersey, USA

Full-time

Job Title: Lead, Regulatory Data Location: Cambridge, MA, Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Lead, Regulatory Data is a strong project leader and expert business analyst who can combine consulting, information quality excellence and digital expertise with pharmaceutical a
Posted 43 days ago | Updated 8 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 28 days ago | Updated 8 hours 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 15 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. uthor 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 degree
Posted 11 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

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 27 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 20 days ago | Updated moments 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 30 days ago | Updated 8 hours ago