21 cfr part 11 Jobs in new jersey

21 - 30 of 30 Jobs

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Warren, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports calibration, equipment qualification and validation activities. Configures and documents the configuration of computerized systems. Dev

LIMS and QC Applications ConsultantJob Title - LIMS and QC Applications Consultant

Expedite Technology SolutionsCompany Name - 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

Sr. Manager, SAP CGTO Solutions ArchitectJob Title - Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.Company Name - Gilead Sciences, Inc.

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Remote or Santa Monica, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses basic

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Raritan, New Jersey, USA

Full-time

Responsibilities: This resource will support the following related to our Service Industrialization (SI) project. Review the Services SI excel spreadsheets for tools, applications and other technologies required to provide the service. There are about 21 spreadsheets Design and set up Mapping Structure for TS Services in SharePoint List Record the technologies from the excel spreadsheets in the Mapping Structure for each Service. Collect the CMDB information for each technology pulled from t

Sr Manager, IT Business Analysis - SAP BRH ArchitectJob Title - Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.Company Name - Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

Snowflake Data ArchitectJob Title - Snowflake Data Architect

VDart, Inc.Company Name - VDart, Inc.

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Princeton, New Jersey, USA

Contract, Third Party

Data Architect C2H Remote This role requires hands-on experience with Snowflake, Matillion, and AWS (or similar technologies), along with strong knowledge of data governance, healthcare standards, and a strategic approach to building scalable, future-ready data systems. Key Responsibilities: Core Architecture and Engineering Design and implement scalable cloud-native architecture, integrating healthcare and PBM data to support Medicare drug pricing, compliance reporting and regulatory requi

Staff Engineer Distribution Quality (Hybrid)Job Title - Staff Engineer Distribution Quality (Hybrid)

Becton Dickinson & CompanyCompany Name - Becton Dickinson & Company

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Remote or Covington, Georgia, USA

Full-time

Job Description Summary As a Quality Engineer at our Distribution Center, you will be instrumental in upholding the highest standards of regulatory compliance and product quality. Your role is critical in maintaining operational excellence, with a strong focus on the quality engineering processes specific to the distribution of medical devices and pharmaceuticals. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing

Principal Software EngineerJob Title - Principal Software Engineer

Amgen IncCompany Name - Amgen Inc

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Remote or Thousand Oaks, California, USA

Full-time

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pati

Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation supportJob Title - Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation support

Futran SolutionsCompany Name - Futran Solutions

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Warren, New Jersey, USA

Full-time

Job Description: Validation Qualification Specialist This role is 100% Onsite Work Schedule: Mon - Fri, Business Hours 1. PURPOSE AND SCOPE OF POSITION: The Validation Engineer supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with facility, utility, and equipment qualification. With minimum sup