993 Biomedical jobs in Raleigh,NC

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CSV Engineer

Alliance Biotech Solutions LLC

Raleigh, NC 27601

RemoteHealth InsurancePaid Time OffRetirement Benefit

Lead Computer System Validation (CSV) activities for custom-developed applications, enterprise databases, data platforms, dashboards, and other GxP computerized systems.
Partner with software developers, data engineers, IT, Quality, and business stakeholders to define validation strategies and ensure compliance throughout the software development lifecycle.
Author and execute validation deliverables including Validation Plans, URS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, test scripts, and Validation Summary Reports.
Validate custom applications, Power BI dashboards, enterprise databases, and cloud-based data platforms while performing SQL-based testing, data reconciliation, and verification activities.
Validate system integrations, data pipelines, APIs, and interfaces between enterprise applications including LIMS, MES, ERP, PI Historian, and related GxP systems.
Verify data integrity, security, audit trail, and electronic records controls to ensure compliance with GxP and regulatory requirements.
Support audit readiness by maintaining compliant validation documentation and providing technical leadership on CSV, CSA, database validation, and data integrity best practices.
Bachelor's degree in Engineering, Computer Science, Information Systems, Software Engineering, Life Sciences, or a related technical discipline.
7+ years of Computer System Validation (CSV) experience supporting custom software applications, enterprise databases, data platforms, and computerized systems within pharmaceutical, biotechnology, medical device, or other regulated industries.
Demonstrated experience validating custom-developed applications, database-driven systems, enterprise integrations, and business intelligence platforms such as Power BI.
Strong knowledge of relational databases, SQL, data architecture, data validation methodologies, and cloud-based data platforms such as Azure Data Lake, Databricks, Synapse, OneLake, SQL Server, Oracle, PostgreSQL, or similar technologies.
Thorough understanding of GAMP 5, Computer Software Assurance (CSA), 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity principles, and cGMP regulations.
Experience leading validation efforts across the software development lifecycle, including requirements, risk assessments, testing, documentation, and audit readiness.
Excellent analytical, troubleshooting, communication, and cross-functional collaboration skills.

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New, Posted 13 hours ago

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Retail Associate/Cashier - Hobby Lobby $18-$22/hr

Hobby Lobby

Garner, NC 27529

$18-$22/hr

No Experience

New, Posted 13 hours ago

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Caregiver (Personal Care Assistant)

SUNRISE SENIOR LIVING SERVICES

Raleigh, NC 27612

OnsiteEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

High School Diploma/GED
Age 18+
CPR/First Aid (or ability to obtain)

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New, Posted 14 hours ago

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Research Scientist (Hiring Immediately)

Jazz Pharmaceuticals

Durham, NC 27713

New, Posted 9 hours ago

Nanny Needed For My Children

Care.com

Garner, NC 27529

New, Posted 1 day ago

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Facilities Technician

Kellanova

Raleigh, NC 27601

OnsiteHealth Insurance

High School Diploma/GED
Previous experience with facility maintenance
Knowledge of standard tools, equipment, materials, methods, and practices in building maintenance crafts
Ability to use basic shop math applications
Ability to read, interpret, and work from rough sketches, blueprints, and drawings
All applicants must have permanent legal authorization to work in the United States.
Kellanova does not sponsor employment visas for this role.

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New, Posted 2 hours ago

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