21 cfr part 11 Jobs

Refine Results
21 - 40 of 87 Jobs

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 50 days ago | Updated 5 hours ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

•

San Francisco, California, USA

Full-time

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 50 days ago | Updated 5 hours ago

Veeva PromoMats Technical Architect

NetHyve Technologies Inc

•

No location provided

Contract

Join IBM's Veeva Practice team as an Architect & Engineer for Veeva Vault PromoMats, where you will be a key leader in shaping and proposing innovative solutions leveraging the power of Veeva and IBM's Consulting AI and Asset based capabilities. You will work closely with clients to understand their unique challenges and develop compelling, tailored solutions that drive digital transformation within healthcare & life sciences organizations. In this role, you will act as a trusted advisor, combin
Easy Apply
Posted 8 days ago | Updated moments ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 50 days ago | Updated 5 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Rockford, Illinois, USA

Full-time

Responsibilities: Perform validation activities to ensure compliance with government and customer requirements. Prepare and execute validation protocols (IOQ, OQ/PQ) and related documentation for new customer/product/system launches. Maintain existing validated processes, coordinating internal and customer approvals as needed. Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals. Assist in the change control pro
Posted 50 days ago | Updated 5 hours ago

Software Quality Engineer

Katalyst Healthcares and Lifesciences

•

Irving, Texas, USA

Full-time

Responsibilities: Review and Approval of software lifecycle (SLC) Deliverables for Regulated applications; Risk Classifications, Requirements, Config/Design Specs, IQ, OQ, PQ, Trace Matrix, Summary Reports etc. Collaborate with the cross-functional teams to build compliance capabilities to assure the quality of the deliverables and ensure the business needs are met. Review of CAPAs, Change Controls and Defects for GxP applications. Working with Global teams and providing audit support. Work
Posted 50 days ago | Updated 5 hours ago

Lead Engineer MES Opcenter

Zettalogix INC

•

Remote

Third Party, Contract

Position: Lead Engineer MES Opcenter RemoteDuration: 6 months with opportunity for extension or conversion Job Description:Lead Engineer MES OpCenter The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted via a third-party and through other client organizations to develop & deploy MES application software to Medical Device manufacturing s
Easy Apply
Posted 7 days ago | Updated 2 days 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
Easy Apply
Posted 23 days ago | Updated 1 hour 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 50 days ago | Updated 5 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,
Easy Apply
Posted 2 days ago

Data Lead with Life Science II CRO

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,
Easy Apply
Posted 2 days ago

Information Technology Manager

ttg Talent Solutions

•

Miami, Florida, USA

Full-time

Job DescriptionJob Title: Manager, IT Location: Coral Springs, FL (100% Onsite) Schedule: Full-time Salary Range: $135,000 $150,000/Year About the Role: Are you a strategic IT leader with a passion for managing technology in a regulated environment? This is your opportunity to lead the IT operations for a state-of-the-art R&D and GMP facility, ensuring efficient infrastructure management, regulatory compliance, and seamless user support. Based in Coral Springs, FL, this role is pivotal in mainta
Posted 3 hours ago

Data Lead with Life Science OR CRO exp

NeoTech Solutions

•

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 L
Posted 2 days ago | Updated 11 hours ago

Manager R&D Quality Risk Management- Princeton

Irvine Technology Corporation (ITC)

•

Princeton, New Jersey, USA

Contract

Manager, R&D Quality Risk Management - Hybrid- Princeton, NJ Join our client as a Manager, R&D Quality Risk Management, where you ll play a pivotal role in overseeing computer system validation (CSV) activities across GxP systems. This position offers the opportunity to work in a highly regulated environment, collaborate cross-functionally, and ensure systems comply with evolving global standards in data integrity and compliance. If you thrive in a quality-driven, dynamic R&D environment, this
Easy Apply
Posted 9 days ago | Updated 2 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 50 days ago | Updated 5 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 50 days ago | Updated 5 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 47 days ago | Updated 5 hours ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

•

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 50 days ago | Updated 5 hours ago

Manufacturing Engineer

Trelleborg Group

•

Delano, Minnesota, USA

Full-time

Trelleborg Medical Solutions is seeking a Manufacturing Engineer to join their team. Responsible for the design and development of optimal engineering solutions for cost-effective lean manufacturing processes. Perform validation activities as necessary in a clean-room manufacturing environment. Recommends improvements to production processes, methods and controls. Supports and may manage manufacturing launch for new or revised products. Salary range Depending on Qualifications and Experience: $
Posted 17 days ago | Updated 6 hours ago

Data Integrity Lead

Katalyst Healthcares and Lifesciences

•

Boston, Massachusetts, USA

Full-time

Responsibilities: Facilitate holistic data integrity reviews by partnering with QA and stakeholders to conduct end-to-end business processes assessments. Prioritize gaps and risks and provide oversight to needed remediation activities. Serving as a Strategic Quality Lead (providing project management, leadership, and participation) for DTE computerized system life cycle (SLC) activities for Vertex GxP systems. Managing and Facilitating Data Mapping initiatives for programs level processes. Provi
Posted 50 days ago | Updated 5 hours ago