21 CFR Part 11 Jobs

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Oracle OPM Consultant at Albany, New York

SAR TECH LLC

•

Albany, New York, USA

Contract

Hi PFA below requirement and let me know your interested Job title:Oracle OPM Consultant Location:Albany, New York Duration: Contract JD - Job Description-The Oracle OPM Consultant will be responsible for the managing the support project including but not limited to implementation, configuration, and ongoing support of Oracle Process Manufacturing (OPM) modules within the pharmaceutical manufacturing environment. The role requires expertise in Oracle OPM and its integration with other Oracle m
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Posted 20 days ago

Clinical Data Specialist

Katalyst Healthcares and Lifesciences

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Illinois, USA

Full-time

Responsibilities: Reporting to the Clinical Data Manager, you'll be responsible for the development of real-world data variables from structured and unstructured data sources, including designing data capture forms and supplemental procedures to instruct the abstraction process. You'll lead the execution of feasibility testing to de-risk data capture approaches and own the implementation of data validation checks to ensure data quality. In addition, you'll work alongside other team members on
Posted 10 days ago | Updated 10 hours ago

Data Integrity QA Validation Engineer

Katalyst Healthcares and Lifesciences

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Rensselaer, New York, USA

Full-time

Responsibilities: Participate on teams of internal resources in delivery of CSV projects. Author functional requirements specifications that are complete, accurate, and testable. Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessments. Author Validation Plans and Validation Reports. Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices. Experience in validation at least two of these computer system categories: automation contro
Posted 60+ days ago | Updated 10 hours ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 5 days ago | Updated 10 hours ago

Medical Device Engineer

Katalyst Healthcares and Lifesciences

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North Chicago, Illinois, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 6 days ago | Updated 10 hours ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil
Posted 10 days ago | Updated 10 hours ago

Validation Engineer

Source Code Technologies LLC

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Sunnyvale, California, USA

Contract

Role name: Validation Engineer Branch | City | Location: Sunnyvale/ Santa Clara, CA Duration: 6 Months Keywords: Key Words to search in Resume Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304 Role Description: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product sof
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Posted 8 days ago

Senior Pharma GxP Project Manager with a strong background in SAP S/4 HANA validation

Pioneer Corporate Services Inc

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Foster City, California, USA

Contract, Third Party

Job Title: Senior Pharma GxP Project ManagerLocation: Hybrid Foster City, CA (Locals or nearby states preferred)Duration: 12 Months Job Description:We are seeking a Senior GxP Project Manager with a strong background in SAP S/4 HANA validation and Life Sciences industries. The role demands excellent stakeholder and change management skills, hands-on validation expertise, and solid project leadership. Must-Have Skills: 15 20 years of overall experience 8+ years in Computer System Validation (CSV)
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Posted 1 day ago | Updated 6 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Job Description: The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11, EU Annex 11, and ISO 13485. This role ensures the systems are compliant, reliable, and fit for intended use, supporting quality and regulatory requirements across the organization. Responsibilities: Develop and execute Computer System Validation (CSV) de
Posted 10 days ago | Updated 10 hours ago

CSV Lead

Laiba Technologies LLC

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Raritan, New Jersey, USA

Third Party, Contract

Role: CSV Lead Location - Raritan, NJ(Hybrid) 7-10 years experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like Serv
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Posted 6 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Raritan, New Jersey, USA

Full-time

Roles & Responsibilities: 7-10 years' experience in Computer System Validation of SAAS systems, and Cloud systems. Must have experience in Agile methodology and handled multiple releases in parallel. Has working experience in any one or two of the following domains Tool validation like Service NOW, Automation tools, JIRA. Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. Application of FDA guidance's a
Posted 8 days ago | Updated 10 hours ago

CSV Lead - Raritan, NJ

Shrive Technologies LLC

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New Jersey, USA

Contract, Third Party

Job Details: 7-10 years' experience in Computer System Validation of EMS and BMS applications Must have experience in Agile methodology and handled multiple releases in parallel Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation, experience with EMS/BMS, project management, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA Gu
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Posted 1 day ago | Updated 1 day ago

Lead IT Validation Consultant

Amaze Systems Inc

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New York, USA

Contract, Third Party

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used
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Posted 1 day ago | Updated 6 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 13 days ago | Updated 10 hours ago

Engineering manager

APN Software Services, Inc

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Cañada de Gómez, Santa Fe Province, Argentina

Full-time

Please contact Abdul on "" OR email me at "" Required Qualifications & Experience Bachelor s or Master s degree in Computer Science, Software Engineering, or a related field. 10+ years of experience in software development, with 2+ years in a leadership role. Strong background in developing software for hardware-integrated applications. Experience managing offshore development teams and working in global, cross-functional environments. Expertise in .NET 4.8 and 8.0, C#, WPF, Golang, JavaScript,
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Posted 1 day ago | Updated 4 hours ago

Oracle Argus Engineer

Spotline

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Alameda, California, USA

Third Party, Contract

Senior Oracle Argus Engineer Alameda CA Onsite role Job Description: Manage implementation/upgrade/support of Oracle Argus Safety System or other Safety solutions and associated interfaces/integrationsPart of technical workstreams (Configuration/Data Migration/Reporting/Upgrade) and provide progress reports, proposals, requirements documentation, and presentations.As Oracle Argus SME, support technical issues associated with Oracle Argus Safety suite and related interfacesHelp deliver project an
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Posted 7 days ago | Updated 3 hours ago

Manhattan Techno Functional Consultant - WMS/TMS/ERP

Sriven Systems Inc.

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Chicago, Illinois, USA

Full-time

Title: This is a Hybrid in position in Waukegan, IL. 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. 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 Warehouse Management Systems (WMS) preferably Ma
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Posted 1 hour ago

Veeva Presales Consultant

NexInfo Solutions, Inc.

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Remote

Contract

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content
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Posted 22 days ago | Updated 4 hours ago

Clinical Systems Specialist

Tandym Tech

•

Woburn, Massachusetts, USA

Contract

A biotech company in Massachusetts has a great Remote contract opportunity awaiting a new Clinical Systems Specialist. In this role, the Clinical Systems Specialist will be responsible for supporting the lifecycle management of clinical systems for Global Development Operations. To be considered for this opportunity, the qualified professional must be able to work on a W2 basis. Responsibilities: Work on planning, design, configuration, and deployment of new clinical systems and enhancements
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Posted 8 days ago | Updated 3 hours ago

Automation Controls Engineer (2ndShift)

Bytecubit Technologies

•

Indianapolis, Indiana, USA

Contract

Job Title: Automation Controls Engineer (2nd Shift)Location: Indianapolis, INDuration: 6 monthsPay Rate: $45/hr-$55/hr (depending on experience) Job Description: This role will be responsible for supporting the design, installation, and validation for the sterile purification and recycling isolators into commercial production. Bachelor s degree in engineering, Computer Science, Automation, or related field with 7+ years of relevant engineering experience in the Pharmaceutical or Chemical indust
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Posted 29 days ago