URS jobs in Raleigh, NC

Durham, North Carolina

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Today

Job Description Summary #LI-Onsite Location: This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible. As a Process Engineer , you will provide advanced engineering expertise to ensure robust, compliant, and efficient drug product manufacturing operations. You'll lead equipment lifecycle activities-from design and qualification through validation and maintenance-while driving reliability strategies and implementing cutting-edge technologi

Full-time

USD 89,600.00 - 166,400.00 per year

Engineer III, Analytical Instrumentation

Durham, North Carolina

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Today

Job Description Summary #LI-Onsite Location: This role is based in Durham, NC. Novartis is unable to offer relocation support: please only apply if accessible. Bring your expertise to a role where precision and innovation drive progress. As Engineer , Analytical Instrumentation, you'll be the subject matter expert ensuring critical laboratory systems operate flawlessly across Quality Control and Technical Research. From leading instrument lifecycle management to solving complex technical challe

Full-time

USD 89,600.00 - 166,400.00 per year

Engineering Technician - Production Support

Clayton, North Carolina

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Today

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply cha

Full-time

Senior Validation Engineer / Lead

Remote or Durham, North Carolina

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Today

Job Description Summary The Senior Validation Engineer is a subject matter expert in the Commissioning and Qualification program and provides leadership and mentorship in the qualification of equipment, utilities, and processes. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is a

Full-time

USD 103,600.00 - 192,400.00 per year

Validation Engineer III

Remote or Durham, North Carolina

•

Today

Job Description Summary The Validation Engineer , is responsible for authoring, executing and reviewing/approval of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsi

Full-time

USD 89,600.00 - 166,400.00 per year

GMP & GxP Business Analyst

Remote

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13d ago

GMP & GxP Business AnalystLocation: RemoteDuration: Long Term Roles & ResponsibilitiesGather, analyze, and document business and user requirements across functional teams.Act as the primary liaison between Business, IT, end users, and cross-functional stakeholders during project execution and maintenance phases.Analyze business challenges and support evaluation of appropriate IT solutions.Collaborate with managers and end users to ensure alignment and buy-in for proposed solutions.Develop detail

Easy Apply

Contract

Depends on Experience

SAP PPQM PTS Consultant Remote

Remote or Atlanta, Georgia

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Today

Job Id: #CGEMJP00321513 Title: SAP PPQM PTS Consultant Location: Remote Duration: 12+ Months Position Summary: Job Role and Responsibilities: We are looking for a highly skilled Senior SAP PPQM Consultant with over 6 years of experience in SAP Production Planning (PP) and Quality Management (QM) modules, specifically within the pharmaceutical industry. The ideal candidate will have a deep understanding of GxP compliance, regulatory requirements, and validation documentation. This role involv

Easy Apply

Full-time, Part-time, Contract, Third Party

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Sr. Process Engineer

Raleigh, North Carolina

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Today

Job Responsibilities include: Serve as equipment owner for project execution including process and facilities design, FAT, startup, SAT, commissioning, and qualification.Execute process, equipment, and facility changes in a cGMP environment.Provide Subject Matter Expert (SME) level technical support to Engineering Design, Construction Management, and CQV/Start-up teams as required for large facility projects.Accountable for downstream process equipment including support and troubleshooting proc

Full-time

Sr. Process Engineer

Remote or Pennsylvania

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Today

Independently, the senior engineer performs discipline responsibilities within Project and Departmental budgets. Engineer is accountable technically and administratively to the Department Manager as well as Project Managers for successfully executing the Process group's work. Engineer is expected to serve in the roles of Project Discipline Lead and Engineer of Record. Engineer is expected to execute multiple projects of different sizes simultaneously. Job Responsibilities include: Serve as robo

Full-time

CQV Engineer

Holly Springs, North Carolina

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Today

Responsibilities: Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC). Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis. Supporting clients change management program - including authoring proposed changes, executing impact assessments/ regression analysis,

Full-time

Computer System Validation (CSV) Engineer

Remote or Massachusetts

•

Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor 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 degree

Full-time

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URS jobs in Raleigh, NC, USA