21 cfr part 11 Jobs

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Validation Engineer

Katalyst Healthcares and Lifesciences

•

Summit, 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 equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems. Develops
Posted 4 days ago | Updated 12 hours ago

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 35 days ago | Updated 8 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Jersey City, New Jersey, USA

Full-time

Responsibilities: Expertise in documenting / guiding various SDLC Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix. Possesses strong communication skills to interact with business stakeholders (Technology Leader, Project Manager, Business Owner). Ability to work with project team to facilitate intera
Posted 60+ days ago | Updated 12 hours ago

Lead Data Engineer (Life Science/CRO/Biotech Domain)

Rivago infotech inc

•

Durham, North Carolina, USA

Full-time

Role: Data Lead with Life Science/ CRO exp Location: Research Triangle Park, NC 27709 (Hyrbid) Hire Type: Fulltime Experience: 10+ years of experience Must Have Skills Required: Architect with familiarity with clinical systems (e.g., EDC, eTMF, CTMS, SAS, Argus) and data standards (e.g., CDISC, STDM). Preferred Skills : Experience with cloud-based data platforms like Azure data bricks and worked on Data Architecture . Knowledge of machine learning and data analytics. Job Description: The Lead,
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Posted 14 days ago

USA - Data Scientist Architect

Apolis

•

Cambridge, Massachusetts, USA

Full-time, Contract

Data Scientist Architect Remote (EST./CST Zone preferred) 6+ months role Pay rate:- $75-85/Hour on W2Job Description:-Position Title: Assoc. Director, PV Systems Reporting & Analytics Function: Global Pharmacovigilance Department: Global PV Operations OBJECTIVE: Oversee and support tools used for the reporting and interactive analysis of data from the global pharmacovigilance (PV) database Provide technical and strategic input into the roadmap, planning, and implementation of projects associa
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Posted 6 days ago | Updated 7 hours ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

•

Kansas City, Missouri, USA

Full-time

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 Manager. Engage
Posted 60+ days ago | Updated 12 hours ago

Computer Systems Validation engineer

Abbott Laboratories

•

Green Oaks, Illinois, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating
Posted 7 days ago | Updated 13 hours ago

Computer Systems Validation engineer

Abbott Laboratories

•

Green Oaks, Illinois, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating
Posted 7 days ago | Updated 13 hours ago

Computer Systems Validation engineer

Abbott Laboratories

•

Green Oaks, Illinois, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating
Posted 7 days ago | Updated 13 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 12 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 12 hours 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 59 days ago | Updated 12 hours ago

Veeva Promomats Technical Lead - 100% remote

MSquare Systems Inc.

•

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 42 days ago | Updated 28 days ago

EMS Validation Engineering Lead

Schneider Electric

•

Horsham, Pennsylvania, USA

Full-time

What will you do? As an EMS Validation Engineering Lead, you will play a lead role in ensuring Schneider Electric's (SE's) Environmental Monitoring System (EMS) deployment meets all industry, regulatory, and customer requirements. This position will be responsible for supporting all aspects of our Life Science projects, from our pre-construction and sales activities, through design and Implementation, to our service and maintenance programs. This position requires a strong blend of project tea
Posted 3 days ago | Updated 12 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

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 12 hours ago

Techno Functional SAP WMS/TMS Consultant

TEKsystems c/o Allegis Group

•

Waukegan, Illinois, USA

Full-time

Top Skills Details 9+ years of SAP WM (Warehouse Management)9+ years of SAP TM (Transportation Management) Description We are seeking a highly skilled Techno-Functional Contractor with deep expertise in SAP Warehouse Management - preferably Manhattan Active-and Transportation Management to support major transformational initiatives in the life sciences sector. The ideal candidate will bridge the gap between business needs and technical solutions, ensuring seamless integration and optimization of
Posted 6 days ago | Updated 8 hours ago

Manhattan Techno Functional Consultant - WMS/TMS/ERP

TEKsystems c/o Allegis Group

•

Waukegan, Illinois, USA

Full-time

We have a client looking for a Techno Functional WMS consultant (Manhattan Active) for a 12 month+ project. This role can be remote but must be on site up to 2 weeks a month in the Chicago area. Rates must be all inclusive. Description We are seeking a highly skilled Techno-Functional Contractor with deep expertisein Warehouse Management Systems (WMS) - preferably Manhattan Active- and Transportation Management Systems (TMS) to support major transformational initiatives in the life sciences sect
Posted 6 days ago | Updated 8 hours ago

Lead Veeva CRM Administrator (Director) | Unique Opportunity to Move to Health Cloud CRM | Established & Growing Biopharmaceutical Co | Hybrid | New Jersey

Miras Search Partners

•

Franklin Township, New Jersey, USA

Full-time

Opportunity Summary Unique opportunity to leverage your deep Veeva CRM Administration experience, and your experience working with patient and/or commercial data to become the Lead Administrator of a Salesforce Health Cloud (Health Cloud) CRM with an established and growing midsized biopharmaceutical company. Key Responsibilities - Develop into the in-house SME for the nascent Health Cloud CRM - Collaborate with multiple stakeholders to optimize their use/ROI of the Health Cloud CRM - Manage/f
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Posted 25 days ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 37 days ago | Updated 12 hours ago

CQV Engineer

Katalyst Healthcares and Lifesciences

•

Rocky Mount, North Carolina, USA

Full-time

Responsibilities: Lead CQV activities for new and modified filling lines, including isolator systems. Develop and execute IQ, OQ, and PQ protocols for filling equipment such as vial washers, dehydrogenation tunnels, filling machines, and capping systems. Perform risk assessments (e.g., FMEA) for filling line modifications and qualifications. Troubleshoot and resolve technical issues during qualification activities Clean Utility System. Manage CQV processes for clean utility systems, including pu
Posted 60+ days ago | Updated 12 hours ago