GXP Jobs in Massachusetts

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GxP Business Analyst/Project Manager

Eliassen Group

•

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 5 hours ago

LIMS Labvantage

Teamware Solutions

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Boston, Massachusetts, USA

Contract

Job Role: LIMS Labvantage Location: Boston, MA (Day 1 Onsite) Duration: 6+ Months ROLE DESCRIPTION: Experience Required: 4 6 Years 3-5 years of experience providing IT support for LIMS systems in a pharmaceutical, biotech, or laboratory setting. Experience with LabVantage LIMS is a must. Strong understanding of laboratory processes, sample management, and analytical workflows. Experience with LIMS system configuration, master data updates, and user management. Familiarity with ITIL processes (in
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Posted 9 days ago

IT Project Manager Lead V - LIMS - Laboratory Information Management System/ LabVantage

Javen Technologies, Inc

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Remote

Contract

Job Title: IT Project Lead V LIMS Project Manager< class="MsoNormal">Location: Remote< class="MsoNormal">Duties: < class="MsoNormal">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.< class="MsoNormal">Domain Knowledge:<>Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage<>Understanding of clinical, research, or diagnostic
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Posted moments 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 1 day ago | Updated moments ago

IT Project Lead V - LIMS Project Manager

Javen Technologies, Inc

•

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 1 day ago

Data Test Manager

Virtualan Software

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Boston, Massachusetts, USA

Full-time, Third Party

Title: Data Validation Test Lead onshore / onsite Location: Boston MA Duration: 12 Months Mode: Hybrid -onsite(3 Days Mandatory) Job Description: Experience in CSV, GxP, and regulatory standardsSkilled professional with a life science or pharmaceutical backgroundStrong knowledge on DWH ConceptsWorking experience on SnowflakeStrong Knowledge on Reports testing - UI and Data TestingStrong knowledge on Various data sources - Flat file, DB, API and othersStrong Knowledge on Various Target interactio
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Posted 30 days 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 14 hours ago | Updated 2 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 24 days ago | Updated 14 hours 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 1 day ago | Updated moments 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 25 days ago | Updated 5 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

Reliability Engineer

Cushman & Wakefield

•

Boston, Massachusetts, USA

Full-time

Job Title Reliability Engineer Job Description Summary As a key member of the Reliability Engineering team, the lead Reliability Engineering will provide strategic and hands-on support for GxP Facility Operations and Engineering across Vertex GxP sites. This role will drive the implementation of maintenance and reliability best practices, focusing on maximizing equipment and system performance while ensuring compliance with GxP and Good Engineering Practices (GEP). The ideal candidate will lead
Posted 12 days ago | Updated 5 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 12 days ago | Updated 5 hours ago

CSV Engineer Role

Katalyst Healthcares and Lifesciences

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Massachusetts, USA

Full-time

Job Description: The CSV Engineer will be responsible for validating and verifying computerized systems that control or interface with laboratory equipment, ensuring data integrity and compliance. This includes writing, reviewing, and executing validation documents in alignment with regulatory expectations. Responsibilities: Validate GxP computerized systems/analytical instruments such as liquid handlers, Cellaca MX, and robotic arms. Lead development and execution of Data Integrity documentat
Posted 55 days ago | Updated 5 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 55 days ago | Updated 5 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 15 days ago | Updated 5 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 5 hours ago

Lead UX designer

Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

A fast-growing scientific data company is hiring a Senior UX Designer to lead the development of AI-powered enterprise design systems. This role is a remote, contract-to-hire opportunity focused on building scientific AI workflows for regulated industries like life sciences and healthcare. You'll be designing mission-critical interfaces that bridge scientific research with machine learning applications including assays, lab instrumentation, and model output visualizations. This is a consulting g
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Posted 2 days ago | Updated 2 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 24 days ago | Updated 5 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Massachusetts, USA

Full-time

Job Overview: Our client seeking an experienced CSV / IT GxP Consultant. This role will focus on ensuring the alignment of internal policies with federal and state regulations, improving our Computer System Validation (CSV) processes, and enhancing third-party vendor compliance. The position will also involve developing and implementing SOPs, as well as managing data privacy and retention policies. The ideal candidate will have experience in GxP regulations and a strong understanding of IT proce
Posted 60+ days ago | Updated 5 hours ago