21 CFR Part 11 Jobs

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Full Stack Developer

Stefanini

•

Minneapolis, Minnesota, USA

Contract

Stefanini Group is looking for Sr Full Stack Developer for a globally recognized company! For interested applicants, click the apply button or you may reach out to Alfher Hidalgo at / for faster processing. Thank you! About the Role: We are looking for a Senior Full Stack Engineer with proven experience in modern web development using Angular (v14+), .NET 8, and Cosmos DB with Azure cloud ecosystems. You will be working on a connected medical device platform that collects therapy data and transm
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Posted 50 days ago | Updated moments ago

Director Contract Research Organization (CRO) SME (Customer Success)

Saama Technologies, LLC

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Remote

Full-time

Director Contract Research Organization (CRO) SME (Customer Success)Location: RemoteDepartment: Customer Success Role OverviewWe are seeking a Director level Contract Research Organization (SME) with deep expertise in Clinical Data Management (CDM) and a modern understanding of clinical data workflows and analytics. This individual will play a critical dual role in ensuring delivery excellence across customer engagements and supporting strategic sales and pre-sales efforts. This is a highly visi
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Posted 12 days ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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New Brunswick, New Jersey, USA

Full-time

Responsibilities: Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in establishing standard quality and validation pract
Posted 60+ days ago | Updated moments ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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Lawrence Township, New Jersey, USA

Full-time

Roles & Responsibilities: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in
Posted 60+ days ago | Updated moments ago

Validation Engineer 4

Katalyst Healthcares and Lifesciences

•

Littleton, Colorado, USA

Full-time

Job Description: We are seeking a detail-oriented and experienced LabVantage Business Analyst to support the implementation, optimization, and ongoing support of LabVantage LIMS (Laboratory Information Management System). The ideal candidate will work closely with business stakeholders, scientists, QA teams, and IT to gather requirements, analyze workflows, and ensure that LabVantage solutions align with organizational needs. Responsibilities: ct as the liaison between scientific/business teams
Posted 60+ days ago | Updated moments ago

IT Enterprise Architect with Life Science Experience

K Source Inc

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Remote

Contract, Third Party

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: IT Enterprise Architect with Life Science Experience Location: Boston, MA (Remote) Duration: 12+ months Job Description: The IT Enterprise Architect is a key role within Gates MRI IT, combing a blend of deep technical and architectural expertise with industry foresight, and strategic thinking. This position is essential for crafting a cohesive IT architecture that sup
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Posted 5 days ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

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Kansas City, Missouri, USA

Full-time

Roles & Responsibilities: Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports). Experience in validating GMP Lab systems and Equipment. Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project. Identify and escalate, as necessary project risks and issues to the CSVC Manage
Posted 60+ days ago | Updated moments ago

Veeva Promomats Technical Lead - 100% remote

MSquare Systems Inc.

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Remote

Contract, Third Party

We are seeking a seasoned Veeva PromoMats Technical Lead to oversee a high-impact migration project within the life sciences domain, transitioning digital content, metadata, and workflows from legacy systems or DAM platforms into Veeva Vault PromoMats. This role is responsible for leading the technical design, validation, and execution of the migration while ensuring regulatory compliance, content integrity, and operational continuity for commercial and medical review teams. Key Responsibilities
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Posted 56 days ago | Updated 13 days ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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California, USA

Full-time

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati
Posted 60+ days ago | Updated moments ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 10 days ago | Updated moments ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Libertyville, Illinois, USA

Full-time

Responsibilities: Lead validation efforts for injection molding machines, auxiliary equipment (e.g., dryers, chillers, robots), and integrated automation systems. Develop and execute validation protocols (SAT, FAT, IQ, OQ, PQ) for molding and downstream equipment. Support the qualification of new production lines involving injection-molded components. Perform process characterization, capability studies, and stability testing for moulded parts. Collaborate with tooling, manufacturing, and q
Posted 4 days ago | Updated moments ago

TMS Consultant / SME

TEKsystems c/o Allegis Group

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Green Oaks, Illinois, USA

Full-time

We have an existing client looking to hire a Supply Chain Consultant for a TMS (Transportation Management System) project. Preferred status will be given to those in the Chicago area, but will also consider out of town candidates working remotely if they are willing to come on site as needed. Our client is currently looking at ways to to make its TMS process more efficient. Requirements have been gathered and now we are looking to bring in a consultant that comes from the IT side, has experienc
Posted 6 days ago | Updated 9 hours ago

Validation Engineer

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
Posted 52 days ago | Updated moments ago

EMS Validation Engineering Lead

Schneider Electric

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Horsham, Pennsylvania, USA

Full-time

For this U.S. based position, the expected compensation range is $96,000 - $144,000 per year, which includes base pay and short-term incentive. The compensation range for this full-time position applies to candidates located within the United States. Our salary ranges are determined by reviewing roles of similar responsibility and level. Within the salary range, individual pay is determined by several factors including performance, knowledge, job-related skills, experience, and relevant educatio
Posted 17 days ago | Updated moments ago

LIMS and QC Applications Consultant

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
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Posted 60+ days ago | Updated moments ago

Systems Administrator / Technical Lead - Process Control Systems

Katalyst Healthcares and Lifesciences

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Foster City, California, USA

Full-time

Job Summary: We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations. This role focuses on deploying system updates
Posted 60+ days ago | Updated moments ago

Software Quality Engineering Lead

Johnson & Johnson

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Remote or New Brunswick, New Jersey, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 4 days ago | Updated moments ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Portsmouth, New Hampshire, USA

Full-time

Responsibilities: Hands on experience in Implementation & Validation of various computerized systems like MES (Syncade) & PLC (COTS). Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements. Experience at working independently as well as in a team-oriented, collaborative environment is essential. Author and Execute CSV life cycle documentation. Requirements: CSV experience of 4+ years.
Posted 60+ days ago | Updated moments ago

Sr. Manager, SAP CGTO Solutions Architect

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
Posted 54 days ago | Updated moments ago

Staff Automation Engineer, Systems

Johnson & Johnson

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Añasco, Añasco, Puerto Rico

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 6 days ago | Updated moments ago