21 cfr jobs in north carolina

Clinical IT Business Analyst (VISA INDEPENDENT CANDIDATES ONLY)

Raleigh, North Carolina

•

Today

Regulated environments such as CRO organizations experience is Huge plus Job Purpose: The Senior Business Analyst (SBA) partners closely with business and technical stakeholders to uncover the true needs of the organization and translate them into clear, actionable, and testable requirements. This role ensures solutions are designed with the end user in mind while meeting enterprise, quality, and regulatory expectations. Key Accountabilities: Elicit and define business requirements Identify true

Easy Apply

Contract, Third Party

Depends on Experience

Loftware Spectrum Technical Lead

Remote

•

3d ago

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

Easy Apply

Contract, Third Party

Depends on Experience

SAP Validation

Remote

•

23d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

Easy Apply

Contract

Depends on Experience

CSA/CSV Validation Consultant

Remote or Arlington, Virginia

•

Yesterday

Role - CSA/CSV Validation Consultant Remote Skills & Experience Required: empower or similar HPLC software Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain Familiarity with QMS processes including deviation management, CAPA, and change control. Strong command of CSA (Computer Software Assurance) principles Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+). Proven ability to write and manage valida

Easy Apply

Contract

PLM Windchill Solution Architect/ SME

Remote

•

Today

Position SummaryWe are seeking a highly experienced Windchill PLM Subject Matter Expert to assess the current PTC Windchill environment and develop a strategic upgrade roadmap for Windchill 2027. The ideal candidate will have strong technical and functional expertise in Windchill, PLM transformation, system upgrades, data migration, and integrations within regulated industries, preferably Medical Devices. Key ResponsibilitiesAssess the existing Windchill environment, including configurations, cu

Easy Apply

Contract, Third Party

Depends on Experience

PLM Windchill Solution Architect/ SME

Remote

•

Yesterday

Role : PLM Windchill Solution Architect/ SME Location : Remote Type : Contract Required Skills & Experience Windchill Expertise 12+ years of hands-on experience with PTC Windchill. Expertise across: Windchill PDMLink ProjectLink MPMLink PartsLink Change Management Document Management Configuration Management Strong knowledge of Windchill versions 12.x/13.x and roadmap toward Windchill 2027. Experience with Windchill upgrades, migrations, and modernization programs. Technical Skills

Easy Apply

Contract, Third Party

Depends on Experience

Product Owner

Remote

•

9d ago

Role OverviewThe Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution.This role blends product management discipline with deep understanding of regulated clinical workflows, ensuring the platform delivers measurable value to sponsors, CROs, research sites, and patients. The PM drives feature development across study startup, patient identification, eligibility, randomiz

Easy Apply

Contract, Third Party

$80 - $85

Computer Vision Engineer

Remote

•

Yesterday

Role: Computer Vision EngineerLocation: Remote with travel required 50%Duration: 6months with possible extensionRole OverviewWe are seeking a Computer Vision Engineer to own the development and integration of real-time automated visual inspection systems for our pharmaceutical packaging lines. In this role, you will design and deploy edge-based vision models that interface with high-speed cameras and IoT hardware to detect packaging defects, verify serialization, and ensure 100% quality complian

Easy Apply

Contract

Depends on Experience

Windchill Solution Architect

Remote

•

Yesterday

Job Description: Summary Seeking an experienced Windchill PLM SME to assess the current PTC Windchill landscape and define the upgrade strategy and roadmap for Windchill 2027. Preference for candidates with a strong Medical Devices background; Life Sciences and Healthcare experience will also be considered. Responsibilities Assess existing Windchill configuration, customizations, workflows, data models, infrastructure, and integrations.Evaluate Windchill 2027 readiness, upgrade risks, technical

Contract

$100 - $130

PLM Windchill Solution Architect

Remote

•

Today

We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for a future upgrade to PTC Windchill 2027. The ideal candidate will possess deep technical expertise in Windchill, strong business process knowledge, and a proven track record of PLM transformation programs within Life Sciences, Healthcare, or Medical Device organizations. The consultant will evaluate the current Windchill implementation landscape, review customizations an

Easy Apply

Full-time

Depends on Experience

Product Owner

Remote

•

17d ago

Iris's direct client, a leader in Healthcare services, looking to hire a strong Product Owner for a Long-Term Contractual role Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, Clinical Trial Platform Job Description: Product Manager Clinical Trial Platform Role Overview The Product Manager for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end-to-end clinical trial executio

Easy Apply

Contract

Depends on Experience

Clinical Trial Product Owner

Remote

•

6d ago

We are hiring for a Product Owner. It s a long-term contract role // Fully Remote role. Title : Product Owner Work Schedule: Fully Remote role. Required Skills : Product Owner with Pharma or Clinical Trial Platform Please email me your resume at Role Overview The Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution. This role blends product owner discipline with deep

Easy Apply

Full-time

Depends on Experience

SAP S/4HANA Program / Project Manager

Remote

•

6d ago

Job Description: SAP S/4HANA Program / Project ManagerExperience: 12+ Years Role: SAP Program / Project Manager Key Skills: SAP S/4HANA, SAP EWM, MM, SD, PP, WM, SAP Activate, Program Governance, Cutover, Data Migration Job Overview : We are looking for an experienced SAP Program / Project Manager to lead large-scale SAP S/4HANA implementations, supply chain transformations, and global rollouts. The ideal resource should have strong experience managing cross-functional teams, system integrator

Easy Apply

Contract, Third Party

Depends on Experience

Loftware Spectrum Technical Lead / Solution Engineer @ Remote

Remote

•

10d ago

Position: Loftware Spectrum Technical Lead / Solution Engineer Location: Remote Duration: 6+ months Job Description: Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable g

Easy Apply

Contract, Third Party

Depends on Experience

Sr. Clinical Developer/ SME (R+Clinical)

Remote or Hybrid in Tampa, Florida

•

8d ago

Hi, Job DetailsPosition: Senior Clinical Developer/SME (R + Clinical)Location: Anywhere on the U.S. East CoastExperience Required: 8+ years of deep R programming experiencePrimary Skills: R, Pharmacokinetics (PK/PD), Clinical Data Processing, CDISC SDTM/ADaMKey Technologies: R Shiny, tidyverse, data.table, PKNCA, mrgsolve, rxode2Clinical Modeling Tools: NONMEM, Monolix, Phoenix WinNonlinReporting Tools: R Markdown, QuartoWork Arrangement: HybridRole OverviewWe are seeking an experienced Senior C

Easy Apply

Third Party, Contract

65 - 70

Senior Windchill PLM Consultant / Windchill Solution Architect

Remote

•

Yesterday

Job Description: We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for a future upgrade to PTC Windchill 2027. The ideal candidate will possess deep technical expertise in Windchill, strong business process knowledge, and a proven track record of PLM transformation programs within Life Sciences, Healthcare, or Medical Device organizations. The consultant will evaluate the current Windchill implementation landscape, review

Easy Apply

Full-time

Depends on Experience

CQV Engineer

Concord, North Carolina

•

14d ago

Summary: Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment. Roles & Responsibilities: Perform CQV activities for standalone equipment. uthor and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and validat

Full-time

Windchill Solution Architect - Medical Device experience

Remote

•

Today

Position Title: Windchill Solution Architect/Senior Windchill PLM Consultant Experience: 12+ Years Location: Flexible / Hybrid Domain: Medical Devices (additionally we can look at candidates from Life Sciences, Healthcare domain as well but preference shall be for candidates with Medical Devices domain background) Employment Type: Full Time / Contract Position Summary We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for

Easy Apply

Third Party, Contract

$70 - $80

Windchill Solution Architect - Medical Device experience

Remote

•

Today

Position Title: Windchill Solution Architect/Senior Windchill PLM Consultant Experience: 12+ Years Location: Remote Domain: Medical Devices (additionally we can look at candidates from Life Sciences, Healthcare domain as well but preference shall be for candidates with Medical Devices domain background) Employment Type: Full Time / Contract Position Summary We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for a future up

Easy Apply

Third Party, Contract

$70 - $80

Veeva Vault Configurator Clinical Suite

Remote

•

Today

Solution IT Inc. is looking for Veeva Vault Configurator Clinical Suite for one of its clients in Remote Job Title: Veeva Vault Configurator Clinical Suite Veeva Vault Configuration & Enhancements Configure and maintain Veeva Vault R&D applications (e.g., Vault Clinical, Vault RIM, Vault Quality, Vault Safety, or related modules). Develop and maintain objects, fields, lifecycles, workflows, roles, picklists, document types, and other Vault components. Execute configuration deployments, manage

Easy Apply

Contract, Third Party

21 cfr jobs in North Carolina, USA