21 CFR Part 11 jobs in Wilson, NC

Wilson, North Carolina

•

Today

Summary : We're looking for dedicated, innovative and driven talent to join our expanding team as we are currently looking to hire an CSV Engineer to join our projects team in Wilson, NC supporting multiple projects with the world's leading Pharmaceutical and Biotech company. Roles & Responsibilities: Automation Change Review and Approval Experience with Emerson Delta other DCS System Develop and complete continuous improvements as part of the validation team- Co-ordination of changes to ens

Full-time

Kneat System Developer (Technical & Validation Focus)

Remote or Parsippany-Troy Hills, New Jersey

•

Today

Job Title: Kneat System Developer (Technical & Validation Focus) Location Remote/WFH Duration: 6 months+ contract Note: Need strong Kneat Development / Configuration and not a user of Kneat. Overview of the Project: You will be configuring Kneat workflows and interacting with business stakeholders. Key Responsibilities: Develop, configure, and maintain Kneat GxP Validation software. Create and manage disciplines and templates. Ensure system validation and compliance with GxP, 21 CFR Part 11,

Easy Apply

Contract, Third Party

SAP Security Architect- Remote , CA (W2 Only)

Remote

•

9d ago

Job Tile: SAP Security Architect location: Remote Duration: 6 Months Key Responsibilities: Lead SAP Security strategy and execution across S/4HANA and integrated systems (Fiori, GRC, Ariba, BTP, SAC, etc.).Review and recommend security architecture solutions aligned with business and compliance needs.Manage and mentor a team of SAP security analysts and consultants.Conduct security workshops and drive role design, provisioning, and governance.Collaborate with IT, audit, and business stakeholde

Easy Apply

Contract

Depends on Experience

Veeva Migration Consultant

Remote

•

28d ago

We have a below position for Veeva Migration expert for remote work, please find the JD below and let me know your interest. Title: Veeva Migration Consultant Exp: 7+ to 10 years of experience in Veeva migration and implementation activities Duration: 6-12 Months Responsibilities: Migration Work stream Lead-Veeva RIMS Implementation Key Responsibilities Migration Strategy & PlanningDefine migration scope, timelines, resources, and success metrics.Develop detailed migration plans and risk mitiga

Easy Apply

Contract, Third Party

Depends on Experience

Salesforce Solution Architect Pharma (Pre-Sales)

Remote

•

Today

Job Title: Salesforce Solution Architect Pharma (Pre-Sales)Location: West Coast & Central US (Remote / Travel as needed) Job SummaryWe are looking for a Salesforce Solution Architect (Pre-Sales) with deep Pharma/Life Sciences domain expertise to support sales pursuits, solutioning, and client engagements. This role will partner closely with sales, business development, and delivery teams to design and present Salesforce-based solutions for pharma clients. Key ResponsibilitiesAct as solution lead

Easy Apply

Contract

$80 - $90

LabVantage LIMS Configurator

Remote

•

Today

RAYVEN IT Solutions is a leading IT Consulting firm offers a comprehensive range of services that are domain specific with a strong focus on technology, business process & practices. Founded by top-notch profs with the vision of bridging the gap between people, process & technology. RAYVEN has the capability & resources to help clients realize their technology driven business transformation initiatives. We are specialized & provide solution-based services to our clients in the areas of SAP/ERP.

Easy Apply

Third Party, Contract

Depends on Experience

CSV ENGINEER | COLUMBUS, OH (REMOTE)

Remote or Columbus, Ohio

•

Today

ONLY 1099 JOB TITLE: CSV ENGINEER JOB DURATION: 1 YEAR JOB LOCATION: COLUMBUS, OH (REMOTE) EXPERIENCE: 8+ YEARS VISA: , - 1099 Job Domain Healthcare Industry Job Description Role: The CSV Engineer 1 will support Computer System Validation (CSV) activities for GxP-regulated systems. This role involves executing validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and company quality standards. The candidate will work closely with IT, Quality, and Business te

Easy Apply

Contract

USD 55-60

Computer System Validation Engineer 1

Remote

•

Yesterday

Title: CSV Engineer 1 Location: Remote About: The CSV Engineer 1 will support Computer System Validation (CSV) activities for GxP-regulated systems. This role involves executing validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and company quality standards. The candidate will work closely with IT, Quality, and Business teams to maintain a validated state of systems. Key Responsibilities Assist in the development and execution of validation documentation, inclu

Easy Apply

Contract

Clinical eTMF Consultant

Remote or Massachusetts

•

Today

Job Title: Clinical eTMF Consultant Department: Clinical Operations Position Summary: The Clinical eTMF Specialist is responsible for managing and maintaining the Electronic Trial Master File (eTMF) system to ensure compliance with regulatory requirements, internal quality standards, and study timelines. This role ensures that all clinical trial documentation is complete, accurate, and inspection-ready at all times. The eTMF Specialist serves as a key liaison between Clinical Operations, Qual

Contract, Third Party

Senior Validation Engineer / Lead

Remote or Durham, North Carolina

•

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

Statistical Software Configuration Specialist (Statistica TIBCO)

Remote or Hybrid in Vacaville, California

•

Today

Statistical Software Configuration Specialist (Statistica TIBCO) Vacaville, CA / A hybrid model (once or twice in the office) / Remote Duration: - 6-12 Months+ For a "Statistica Software configuration specialist" role, which likely involves both data analytics and potentially on-site manufacturing support or collaboration, a hybrid model (once or twice in the office) is a probable arrangement. Statistical Software Configuration Specialist (Statistica TIBCO) Position Overview The Statistical Soft

Easy Apply

Third Party, Contract

Depends on Experience

CSV and Validation Engineer

Remote or New Jersey

•

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

Director - Lab Informatics

Remote

•

Today

Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory complianc

Easy Apply

Third Party, Contract

Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing)

Remote or Foster City, California

•

Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 126,820.00 - 164,120.00 per year

Sr. IT Program Manager

Remote or Massachusetts

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Uncover a remarkable opportunity at Thermo Fisher Scientific Inc. to push global advancements in health, cleanliness, and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team, guiding ambitious IT projects that enhance quality, compliance, and supply chain operations within our Contract Development and Manufacturing Organization (CDMO). Argument Development & Case Creation Collaborate

Full-time

USD 143,000.00 - 214,475.00 per year

Manager, IT Business Analysis

Remote or Foster City, California

•

Today

Full-time

USD 146,540.00 - 189,640.00 per year

Associate Director, Machine Learning Engineer

Remote or Thousand Oaks, California

•

Today

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pat

Full-time

Senior CSV Engineer

Remote or Massachusetts

•

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

Principal SAP Architect, Enterprise Asset Management (EAM)

Remote

•

Today

Full-time

USD 154,142.00 per year

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

Filter Results

Job post features

Posted date

Work settings

Employment type

Distance

Employer type

Work authorization

21 CFR Part 11 jobs in Wilson, NC, USA