Gxp jobs in cambridge, ma

Technical Project Manager - SaMD / GxP Validation

Remote

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Today

Technical Project Manager - SaMD / GxP Validation. We need an independent, Quality-first project manager to drive an imaging algorithm Software as a Medical Device (SaMD) program in R&D IT toward a trial launch targeted for Q3. You will run the plan, clear blockers and own the validation documentation, all within a regulated Quality Management System (QMS). This is a technology role, not clinical operations, and we want someone who can start delivering in week one. Engagement 12-month contract

Contract

$60.00 - $80.00

Manufacturing System Administrator

Cambridge, Massachusetts

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Today

Must Have's: 1. System Administration for Technology Systems like MES, PlantPax, Aveva PI, Tracelink, RTMS, PIMS, CMMS, etc. 2. Strong communication and collaboration skills 3. GxP Documentation The Manufacturing Systems Administrator Contractor will provide technical and systems administration support for manufacturing and operational technology systems, including MES, INFOR CMMS, AVEVA PI, PIMS, PlantPAX, TraceLink, NSIDE and RTMS. The contractor will support the designated System Owner in

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Contract

Depends on Experience

GxP Systems and Support Administrator

Remote

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Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Manufacturing System Administrator

Cambridge, Massachusetts

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Today

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Contract

Depends on Experience

Lab Support Engineer

Bedford, Massachusetts

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30+d ago

Job Description Must Have Technical/Functional Skills Lab System Deployment and Systems Management knowledge, Knowledge in handling GxP environment, JAMF, Windows 11, Windows 10. JAFM to manage Apple Devices, Microsoft Intune, Windows Auto Pilot. Rescue LogMeIn, Servicenow, Zoom, Microsoft SCCM preferred. Roles & Responsibilities 1. Configuring and monitoring the LAB oriented software within the LAB (Quality and production) 2. Co ordinating with LAB software vendor and maintaining the license an

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Full-time

60,000 - 80,000

Validation Engineer I

Waltham, Massachusetts

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Today

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role ElevateBio is looking to hire a Validation Engineer I to join the Validation Engineering. The Validation Engineer I will perform qualificati

Full-time

USD 105,000.00 - 145,000.00 per year

Validation Engineer

Burlington, Massachusetts

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Today

Join a dynamic quality assurance team supporting validation activities for SAP S/4HANA, integrations, and data migration initiatives. This role offers the opportunity to help shape validation strategy, strengthen testing automation, and contribute to high-impact enterprise systems work in a collaborative environment. Responsibilities Develop validation plans, test strategies, and test scripts for SAP S/4HANA, integrations, and data migration efforts. Build and maintain automation assets using

Full-time

USD 22.00 - 35.00 per hour

CSV Engineer (Analyst II)

Cambridge, Massachusetts

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15d ago

About the job: The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including both on premises and Cloud/Server based applications, are validated and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, conducting risk assessment, and providing valida

Full-time

Senior Systems Analyst II, R&D Systems

Waltham, Massachusetts

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Today

Job Description Alkermes is seeking a Sr. Systems Analyst, within the R&D IT team. This person would work closely with our Development, Clinical, Regulatory and Medical, DSPV organizations to evaluate, implement, enhance and support current systems and solutions. They will assist in optimizing data capture, data aggregation, and data analysis. The preferred candidate will utilize their experience to implement key functionality within these groups to help facilitate the development/clinical/regu

Full-time

USD 120,000.00 - 140,000.00 per year

Computer Systems Validation Engineer

Boston, Massachusetts

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Today

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

VP of Technology

Needham, Massachusetts

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Today

Description We are looking for a strategic and hands-on technology executive to guide the company's IT direction during a pivotal stage of growth in Needham, Massachusetts. This leader will shape enterprise systems, cybersecurity, infrastructure, data capabilities, and digital innovation while partnering closely with senior leadership and cross-functional teams. The role is responsible for building scalable, compliant, and business-ready technology operations that support clinical development an

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Full-time

USD 300,000.00 - 350,000.00 per year

SAP Implementation Lead

Billerica, Massachusetts

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Today

Software Guidance & Assistance, Inc., (SGA), is searching for a SAP Implementation Lead for a direct placement assignment with one of our premier Pharmaceutical Services clients in Billerica, MA. Responsibilities : Process Design & Operational Enablement: Lead design, mapping, and optimization of manufacturing processes in consultation with global process owners Work with Digital/IT to translate operational requirements into SAP S/4HANA configuration Validate master data from an operations

Full-time

USD 96,600.00 - 96,600.00 per year

Director, AI Research

Boston, Massachusetts

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Today

Job Title: Director, AI Research Introduction to role: Are you ready to bring frontier AI into the heart of clinical development and change how trials are designed, conducted, and analyzed? Can you move seamlessly from a clinical question to the AI system that answers it and stands up to scientific and regulatory scrutiny? In this director-level role, you will define and deliver the AI research agenda that improves decisions for trials and patients across Oncology and BioPharmaceuticals. You

Full-time

Compensation information provided in the description

CSV Systems Engineer III

Hopkinton, Massachusetts

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Today

Job Description CSV Systems Engineer in Hopkinton, MA Build your future at Curia, where our work has the power to save lives. The CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections. Curia is a g

Full-time

USD 122,800.00 - 145,300.00 per year

Lead Engineer, Microsoft 365 and Identity Automation

Cambridge, Massachusetts

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Today

Flagship Pioneering is a biotechnology company that invents and builds platform companies that change the world. We bring together the greatest scientific minds with entrepreneurial company builders and assemble capital to allow them to take courageous leaps. Those big leaps in human health and sustainability exponentially accelerate scientific progress in areas ranging from cancer detection and treatment to nature-positive agriculture. What sets Flagship apart is our ability to advance biotechn

Full-time

USD 128,000.00 - 176,000.00 per year

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Waltham, Massachusetts

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Today

Job Description This position provides leadership and accountability for Digital Quality across the organization's Quality, Regulatory, and R&D systems landscape, with responsibility for supporting computer system validation activities in alignment with applicable regulatory expectations, internal procedures, and data integrity requirements. The role is focused on ensuring GxP computerized systems are implemented, maintained, and governed in a compliant, risk-based, and inspection-ready manner

Full-time

USD 110,000.00 - 126,000.00 per year

Principal Automation Software Engineer

Framingham, Massachusetts

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Today

Job title: Principal Automation Software Engineer Location: Framingham, MA About the job: The Bioanalytics Automation Lab is looking for an automation software engineer to join our team. The individual in this role will be responsible for developing, maintaining, and deploying software solutions that automate laboratory instruments, robotics, sample handling systems, and associated data workflows. Works closely with scientists, engineers, and vendors to integrate instrumentation, optimize proce

Full-time

USD 122,250.00 - 176,583.33 per year

Director, RDU IT - Business Partner, Global Medical Affairs IT

Cambridge, Massachusetts

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Today

Role Overview As Director, IT Business Partner - Global Medical Affairs, you will serve as the primary IT leader interfacing with Medical Affairs in the Rare Disease Unit (RDU). In this strategic role, you will drive the development and execution of a forward-looking technology roadmap for Medical, championing digital transformation, continuous improvement, and operational excellence. By proactively identifying opportunities for innovation and supporting Medical's evolving scientific, clinical

Full-time

USD 153,018.00 - 229,527.00 per year

SAP Validation

Remote

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24d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

Sr. Principal Cloud Lead

Milford, Massachusetts

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Today

Overview Do you want to help shape the future of Enterprise Cloud at Waters? Would you like to lead cloud strategy and engineering initiatives that enable secure, scalable, and compliant platforms across AWS and Azure? How about an opportunity to modernize enterprise workloads and establish the next generation of cloud capabilities across the company as we scale to 16K employees? Do you want to be part of a global digital transformation journey and help grow multi-million $$ digital and B2B eCo

Full-time

Gxp jobs in Cambridge, MA, USA