Computerized system validation jobs in massachusetts

Remote or West Point, Pennsylvania

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Today

Kelly Science and Clinical FSP is currently seeking a Metrology Specialist for a long-term engagement with one of our Global Pharmaceutical clients in West Point, PA. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from.

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Contract

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

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

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 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

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

Computer Systems Validation Engineer

Remote

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Today

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

Full-time

USD 150,000.00 - 178,000.00 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

Solutions Engineer Intern 2027 (USA)

Remote or San Francisco, California

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Today

About Pinterest: Millions of people around the world come to our platform to find creative ideas, dream about new possibilities and plan for memories that will last a lifetime. At Pinterest, we're on a mission to bring everyone the inspiration to create a life they love, and that starts with the people behind the product. Discover a career where you ignite innovation for millions, transform passion into growth opportunities, celebrate each other's unique experiences and embrace the flexibility

Full-time

USD 7,500.00 - 9,500.00 per month

IT Principal Software Engineer

Remote or Englewood, Colorado

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Today

Where You'll Work Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation's largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 137 hospital-based locations, in addition to its home-based services and virtual care offerings. CommonSpirit has

Full-time

USD 54.76 - 81.45 per hour

Sr. Clinical Developer/ SME (R+Clinical)

Remote or Hybrid in Tampa, Florida

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8d ago

Hi, Job DetailsPosition: Senior Clinical Developer/SME (R + Clinical)Location: Anywhere on the U.S. East CoastExperience Required: 8+ years of deep R programming experiencePrimary Skills: R, Pharmacokinetics (PK/PD), Clinical Data Processing, CDISC SDTM/ADaMKey Technologies: R Shiny, tidyverse, data.table, PKNCA, mrgsolve, rxode2Clinical Modeling Tools: NONMEM, Monolix, Phoenix WinNonlinReporting Tools: R Markdown, QuartoWork Arrangement: HybridRole OverviewWe are seeking an experienced Senior C

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Third Party, Contract

65 - 70

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

MES Engineer

Massachusetts

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14d ago

Summary: The MES Engineer will play a critical role in supporting the design, development, implementation and management of the Manufacturing Execution Solutions (MES) within the organization's Drug Product manufacturing area. This role involves translating manufacturing processes into robust MES solutions, ensuring compliance with GxP standards, and integrating MES with other enterprise systems and automation platforms to streamline operations. Roles & Responsibilities: Assist in the design a

Full-time

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

Cloud Pipeline Data Engineer

Remote or Arlington, Virginia

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Today

Job Title: Cloud Pipeline Data Engineer Job Category: Engineering Time Type: Full time Minimum Clearance Required to Start: Secret Employee Type: Regular Percentage of Travel Required: None Type of Travel: None * * * The Opportunity: The Cloud Pipeline Engineer will support data ingest and transformation for a government financial reporting system. You will support cloud-based data intake and storage, data ingestion automation, and ensuring the reliability of processes responsible for d

Full-time

USD 98,500.00 - 206,800.00 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

Computerized system validation jobs in Massachusetts, USA