gxp Jobs in boston, ma

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Technical Writer with GxP

Hireblox

Remote

Full-time

Job Title: Technical Writer Job Summary: Location: Remote (Eastern Time Hours) Job Type: Contract/ Hourly Full time 40 hours/week Duration: 6 months with high potential extension Responsibility for developing and revising procedures (Procedures, Work Instructions, Job Aides) with input from cross-functional teams, subject matter experts, and the Global Process Owners. This role requires a deep understanding of GxP practices, particularly in Document Management, and Learning Management systems. K

Benchling Technical Support Specialist (GxP / CSV Experience Preferred)

Infinite Computer Solutions (ICS)

Remote

Contract, Third Party

Job Summary: We are seeking a skilled and proactive Technical Support Specialist with hands-on experience supporting Benchling, a leading cloud-based platform for life sciences R&D. The ideal candidate will have a strong background in providing technical application support within a regulated GxP environment, and exposure to Computer System Validation (CSV) is highly desirable. The role requires close collaboration with the client s IT and Quality teams to ensure consistent and compliant system

Benchling Subject Matter Expert (SME)/Consultant

Sumeru

Boston, Massachusetts, USA

Full-time

- Job Title: Benchling Subject Matter Expert (SME)/Consultant - Location: Boston, MA (Preferred) | Remote Considered as a Last Resort - Position Type: Full-Time - Role: Implementation, configuration, and optimization of the Benchling platform - Key Responsibilities: Solution design & implementation, client collaboration, training & support, compliance, and innovation - Required Qualifications: 5+ years of hands-on Benchling experience, background in life sciences, project management skills,

Sycamore SCE Administrator (Statistical Computing Environment)

Virtualan Software

Boston, Massachusetts, USA

Contract, Third Party

Job Title: Sycamore SCE Administrator (Statistical Computing Environment) Location: Hybrid at Boston, MA Job Type: C2C / Full time Overview: We are seeking an experienced Sycamore SCE Administrator to manage and maintain our Statistical Computing Environment (SCE) used for clinical and statistical analysis. The ideal candidate will have deep hands-on experience with the Sycamore platform and a strong background in statistical computing within regulated environments such as pharmaceuticals or lif

Digital Product Owner (Director) In Silico CMC

Sanofi EU

Cambridge, Massachusetts, USA

Full-time

Job Title: Digital Product Owner (Director) In Silico CMC Location: Cambridge, MA, Framingham, MA or Morristown NJ About the Job 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 responsibly to search deeper and solve R&D problems sooner than ever before. Join our in-silico CMC Digital team as a Digital Product Owner and you can help make it happen. Your job? Driving Transformation throughou

Head of Supply Chain NA

Sanofi EU

Cambridge, Massachusetts, USA

Full-time

Head of Supply Chain NA Location: Morristown, NJ or Cambridge, MA About the job Define and drive the Supply Chain strategy to support top and bottom-line growth ambition of Commercial Operations of the markets in scopeRepresent the affiliate as the key Supply Chain stakeholder, both internally and externally to the company, acting as the primary contact for that country in the regional and global Supply Chain organizationLead the Supply Chain department transformation: Continuously review and r

Digital Product Owner (Director) In Silico CMC

Sanofi EU

Framingham, Massachusetts, USA

Full-time

Job Title: Digital Product Owner (Director) In Silico CMC Location: Cambridge, MA, Framingham, MA or Morristown NJ About the Job 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 responsibly to search deeper and solve R&D problems sooner than ever before. Join our in-silico CMC Digital team as a Digital Product Owner and you can help make it happen. Your job? Driving Transformation throughou

Reliability Engineer

Cushman & Wakefield

Boston, Massachusetts, USA

Full-time

Job Title Reliability Engineer Job Description Summary This individual will provide support for GxP Facility Operations/Engineering department at Vertex GxP sites as part of the Reliability Engineering team. The ideal candidate will be responsible for ensuring the reliability and performance of our equipment/systems through Reliability best practices and continious improvement initiatives. This role will also execute documentation/forms/spreadsheets to roll out Maintenance and Reliability Best

Senior AI Architect

MRoads

Remote

Contract

Required Skills: Proven experience in AI architecture and design, particularly with LLMs and AI agents.Strong understanding of GXP regulations and their application in AI solutions.Excellent communication skills to effectively collaborate with cross-functional teams.Ability to establish and enforce design principles that enhance user experience.

Benchling Technical Support Resource

Sierra Software Solutions

Remote

Contract

Hello Professionals, There's an open position at Sierra Software Solutions with one of our esteemed clients. If this role aligns with your experience and career aspirations, I d be happy to share more details and discuss it further. Please find the job description below. Role: Benchling Technical Support Resource Location: Bridgewater, NJ Work Remotely: Yes Required Skills: Experience with technical support for Benchling. Sector: Distribution Industry: CPG/Wholesale Thanks, Nagendar Nakka

Computer System Validation Specialist

SGS Consulting

Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r

AWS Solution Architect, Regulatory Strategy : : and USC

Srimatrix Inc.

Remote

Contract, Third Party

Role: Solution Architect, Regulatory Strategy location: Remote (EST Hours) **MUST HAVE Pharmaceutical Regulatory experience **AWS-Certified Solutions Architect certification required Education: BA/BS degree in a technical, engineering or scientific fieldAWS-Certified Solutions Architect certification requiredAWS Well-Architected Framework certification desirableAWS Certified Machine Learning Specialty certification desirable Experience and Skills: Required: Understanding of Pharmaceutical Regul

LIMS and QC Applications Consultant

Expedite Technology Solutions

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

Global Labeling Strategist

Sureminds Solutions

Remote

Contract, Third Party

Please share Profiles at Hi, Urgent need, Job Title: Global Labeling Strategist Work Location Remote C2C Requirement Global Labeling Strategist has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the Centralized, Mutual Recognition or Decentralized Procedure. Responsibilities: Drives labeling strategy in partnership with the Global

Trackwise Digital Architect

VeridianTech

Texas, USA

Full-time

Trackwise Digital Architect Remote Requirement Experience with designing and implementing IT systems. Experience with understanding specifications, evaluate current application, gather requirements, and work closely with stakeholders to deliver the right solution Experience working and implementing systems using TrackWise Digital platform. Hands on experience in TrackWise Digital Application setup: Permission Sets, Configuring Platform Custom Settings, Configuring Remote Site Settings, E-s

IT Quality System Analyst

Visionary Integration Professionals

Billerica, Massachusetts, USA

Full-time

Visionary Integration Professionals (VIP) provides industry-leading management consulting, system integration, and technology deployment solutions. VIP helps its clients strengthen mission outcomes by combining deep industry specialization, agility to adapt as needed, and an unwavering commitment to client satisfaction. VIP brings expertise in how to deploy systems that align people, processes, and technology to accelerate strategic change and to deliver business results in partnership with its

SAP Quality Business System Analyst

Visionary Integration Professionals

Billerica, Massachusetts, USA

Full-time

Visionary Integration Professionals (VIP) provides industry-leading management consulting, system integration, and technology deployment solutions. VIP helps its clients strengthen mission outcomes by combining deep industry specialization, agility to adapt as needed, and an unwavering commitment to client satisfaction. VIP brings expertise in how to deploy systems that align people, processes, and technology to accelerate strategic change and to deliver business results in partnership with its

AI Engineer

Thermo Fisher Scientific

Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as an AI Engineer to implement innovative AI and ML methods for our GxP Quality Management System. Key Responsibilities: Build AI Solutions: Develop predictive models, anomaly detection systems, and LLMs to optimize QMS performance.Improve GenAI and LLMs: Apply Generative AI techniques and LLMs to automate and improve tasks like quality events analysis, document reviews, and complaint management.Work wit

Sr Manager, Data Sciences

Thermo Fisher Scientific

Remote or Chicago, Illinois, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest inve

Specialist , IT/OT Technology Compliance (Hybrid - West Point, PA)

Merck & Company Inc

Remote or West Point, Pennsylvania, USA

Full-time

Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous matur