Computerized System Validation jobs in Cambridge, MA

Computer System Validation (CSV) Lead - Oracle Fusion

Boston, Massachusetts

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22d ago

No OPT/CPT Job Summary We are seeking an experienced Oracle Fusion Computer System Validation (CSV) Lead to support the implementation, validation, and ongoing lifecycle management of Oracle Fusion applications within a regulated life sciences environment. The ideal candidate will have strong experience validating Oracle Fusion Cloud ERP applications, leading risk-based CSV/CSA activities, and ensuring compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, and applicable GxP requi

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Full-time

55 - 60

CSV Engineer

Boston, Massachusetts

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14d ago

Job Description: Seeking experienced CSV Engineers to provide onsite validation support within a regulated biopharmaceutical manufacturing environment. The primary focus of the position will be Computer System Validation, while also supporting equipment qualification and broader CQV activities as project priorities require. Consultants will support validation documentation and execution activities, assess computerized systems against GMP requirements, execute approved validation protocols, do

Full-time

Senior Validation Engineer I

Lexington, Massachusetts

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Today

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by

Full-time

USD 104,541.00 - 141,240.00 per year

CSV Validation Engineer

Boston, Massachusetts

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14d ago

Job Summary We are seeking a Medical Device Quality / CSV Validation Engineer to support quality system compliance, CAPA remediation, spreadsheet validation, and computer system/software validation activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk Roles & Responsibilities Review spreadsheet inventories and assess validation requirements based on applicable procedures, risk, and quality standards. Perfo

Full-time

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

SSB-Databrick Eng

Boston, Massachusetts

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Today

Job Requirements .Data Engineer (Databricks & AWS) - Realty Data Platform Role Summary We are seeking a Data Engineer to help design, build, and scale a modern Realty Data Platform on AWS and Databricks. This role will be responsible for developing data pipelines, integrating data from multiple internal and external sources, and creating trusted datasets that support analytics, reporting, and AI/ML-driven insights across the Real Estate organization. The ideal candidate combines strong hands-o

Full-time

Commissioning, Qualification, and Validation (CQV) Engineer

Boston, Massachusetts

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Today

Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Full-time

Process Technology & Innovation Lead PAT

Lexington, Massachusetts

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Today

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Process Technology & Innovation Lead PAT is responsible for defining and driving Takeda's global Process Analytic

Full-time

USD 177,000.00 - 278,080.00 per year

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

CSV Engineer (Analyst II)

Cambridge, Massachusetts

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14d 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

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

Data Migration Engineer

Somerville, Massachusetts

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Today

Responsibilities Job description Develop and execute comprehensive strategies for RIS data migration.Collaborate with stakeholders to gather and analyze migration requirements.Extract clinical, operational, and administrative data from legacy RIS systems.Assess and map legacy data structures, including patient demographic records, diagnostic radiology reports, scanned documents, and future appointments.Assist in assembling and loading RIS system's master lists including referring physicians, in

Full-time

USD 90,000.00 per year

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

Solutions Design Engineer

North Reading, Massachusetts

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Today

Job#: 3054934 Job Description: Solutions Design Engineer Location: North Reading, Massachusetts (Hybrid) Alternate Location: Boston, Massachusetts; Westborough, Massachusetts Role Overview This position is for an individual who will be responsible for scaling design efforts for a global material handling solution. The role focuses on building automation tools for the engineering team and partnering with fellow engineers to understand business needs. The successful candidate will be a self-s

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Full-time

$35 - $38 per hour

Lead Data Engineer

Cambridge, Massachusetts

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Today

ABOUT FLAGSHIP PIONEERING Flagship Pioneering is a life sciences innovation enterprise that invents and builds transformative companies. Since its founding in 2000, Flagship has originated more than 100 ventures, including Moderna, and has deployed over $4 billion toward scientific discovery. Our Scientific Cloud team is the connective tissue that powers data and technology infrastructure across Flagship's growing portfolio of companies. About Scientific Cloud: Scientific Cloud is Flagship Pione

Full-time

USD 128,000.00 - 176,000.00 per year

SIEM Data Engineer

Quincy, Massachusetts

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14d ago

Who we are looking for We are looking for a SIEM Data Engineer reporting directly to the Cyber Data Engineering Manager. You will support the onboarding, transformation, routing, validation, and operational support of cybersecurity telemetry and enterprise log data used for security monitoring, analytics, reporting, incident response, and cyber data science use cases. This role is focused on understanding diverse enterprise data sources, building and maintaining security telemetry pipelines, val

Full-time

USD 90,000.00 - 157,500.00 per year

SIEM Data Engineer

Quincy, Massachusetts

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Today

Full-time

USD 90,000.00 - 157,500.00 per year

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

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14d ago

Job Summary: leading organization is seeking an experienced Pharma IT Testing & Validation Delivery Lead to manage global testing and validation services across multiple Life Sciences programs. Roles & Responsibilities: Own end-to-end testing and validation delivery across multiple pharmaceutical IT projects. Lead onsite and offshore QA teams across the United States, United Kingdom, and India. Define testing strategy, governance, KPIs, delivery standards, and quality metrics. Oversee functional

Full-time

Alpha Data Implementation Business Analyst- Assistant Vice President

Burlington, Massachusetts

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Today

What we are looking for State Street Alpha Data Implementation organization is seeking individuals with subject matter expertise spanning a wide array of financial instrument types and working knowledge of Asset Management Data Domains to join our team as an Implementation Business Analyst. Why is this role important Implementation Business Analysts are at the heart of continued growth of our Alpha Data Services offering. These energetic, self-motivated individuals collaborate with clients an

Full-time

USD 80,000.00 - 140,000.00 per year

Remote Senior Analytics Engineer - Python/Data Visualization

Remote

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Today

Job Description A leading organization serving the Property & Casualty insurance industry is seeking a Senior Analytics Engineer to join a team responsible for developing and enhancing internal data and analytics solutions that drive business growth and strategic decision-making. In this role, you will help build and maintain a Python-based analytics platform that processes carrier and market data, validates and standardizes information, automates reporting, and delivers actionable insights to

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Contract

USD 40.00 per hour

Computerized System Validation jobs in Cambridge, MA, USA