21 CFR Part 11 jobs

Senior Data Architect, Integrated Data Platform

San Francisco, California

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17d ago

Key ResponsibilitiesData Modeling and Architecture Lead the design of the Integrated Data Package (IDP) data model, covering multi-modal study assets including DICOM imaging, omics, and real-world data sources Define the two-layer data architecture: operational relational layer for study metadata, cataloging, and access registry; lakehouse layer for versioned study assets at scale Design schemas, partitioning strategies, and table formats across relational (PostgreSQL) and open table format (

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Contract

Depends on Experience

Computer Systems Validation Engineer

Indianapolis, Indiana

•

5d ago

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

Senior Implementation Engineer – Tulip MES

Indianapolis, Indiana

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13d ago

Job Title: Senior Implementation Engineer Tulip MES Location: Indianapolis, IN / Kansas City / Winslow, ME / Iowa (100% Onsite) Duration: 6+ Months Employment Type: W2 / Independent Consultant Job Description: We are seeking a Senior Implementation Engineer Tulip MES to design, configure, and deploy digital manufacturing solutions across pharmaceutical production facilities. Responsibilities: Develop and configure Tulip applications for manufacturing operations Implement Electronic Batch Rec

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Contract

Depends on Experience

Senior Data Architect with Integrated Data Platform Exp - W2

Remote

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5d ago

Senior Data Architect to lead the data modeling and platform design for a next-generation Integrated Data Platform (IDP) supporting a regulated medical imaging program at a global pharmaceutical and diagnostics company. This role is responsible for defining the data architecture across relational and lakehouse layers, governing the structure of versioned study-level data packages, and enabling cross-modal data access for imaging, omics, and real-world data. The architect will design for GxP comp

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Contract

Depends on Experience

CSV Analyst with Instrument integration & Validation expertise

Cincinnati, Ohio

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5d ago

Role : CSV Analyst with Instrument integration & Validation expertise Location : Cincinnati, Ohio We are seeking a 10+ Yrs. of strong regulated lab validation experience in Instrument integration & Validation Analyst to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments to the integration layer confirming that data moves accurately and completely from the instrument, through Instrument Manager, into the LIS, and through any re

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Third Party, Contract

Depends on Experience

Urgent need on Automation Tester with Pharma/Salesforce Marketing Cloud, CA

Foster City, California

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6d ago

VERY URGENT REQUIREMENT Job Description: Automation Tester with Salesforce Marketing Cloud Location: Foster City, CA (ONSITE) Duration: 6-12 months Automation Tester Life Sciences / Medical Affairs (GxP) We are seeking an experienced Automation Tester with strong expertise in Life Sciences / Medical Affairs systems to join our team. This role requires domain knowledge in GxP compliance, 21 CFR Part 11, and hands-on experience with Salesforce Marketing Cloud and Veeva platforms. Key Responsibi

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Contract

Depends on Experience

Sr. Computerized System Validation (CSV) Manager

Remote

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30+d ago

We are Looking for a Senior Computerized System Validation (CSV) Manager with CRO industry experience. This a full-time permanent hire position with our client. In this role you can work fully remote (anywhere in USA). In this role as a Senior Computerized System Validation (CSV) Manager, you will lead the transformation of CSV practices within the organization. In this role as a Senior Computerized System Validation (CSV) Manager you will ensure validation processes are risk-based, efficient, a

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Full-time

Depends on Experience

Senior Full Stack Software Engineer

New Castle, Delaware

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5d ago

Overview We need your talent! Waters Corporation is currently seeking a Senior Full Stack Software Engineer to join our Global Software Engineering team. Our team understands the value of their work in the real world. As a Senior Full Stack Software Engineer in New Castle, Delaware, you'll be working on instruments that are pivotal in: Electric Cars, 3D Printing, batteries, recyclable plastics, space suits, candy that melts in your mouth and not your hands, paint that goes on smooth and dries w

Full-time

SAS Viya Developer

Raleigh, North Carolina

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16d ago

Position: SAS Viya Developer Location: Raleigh, NC Duration: Contract Role OverviewWe are seeking a highly experienced SAS Viya devloper with experience between 5 to 10 years of expertise in clinical data programming, CDISC standards, and cloud-based analytics platforms. The ideal candidate will lead end-to-end clinical data workflows, regulatory submissions, and modern data platform transformations in GxP-regulated environments.This role requires strong domain expertise in SDTM, ADaM, regulato

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Contract, Third Party

$60

Validation Engineer

Waltham, Massachusetts

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5d ago

Job Summary: We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment. This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV). Roles & Responsibilities: Perform validation and calibration activities for pharmaceutical manufacturing and s

Full-time

CQV Engineer

Austin, Texas

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5d ago

Job Summary: We are seeking a motivated and detail-oriented Validation / CQV Engineer to support qualification and validation activities in a regulated pharmaceutical/biotech environment. The ideal candidate will have hands-on experience in IQ/OQ execution, Computer System Validation (CSV), and validation documentation while ensuring compliance with regulatory standards including 21 CFR Part 11, ALCOA principles, and GAMP guidelines. The role involves working with laboratory systems and environm

Full-time

CSV Engineer

Indiana

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5d ago

Job Summary: The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant with regulatory standards, including 21 CFR Part 11. The role requires strong expertise in GAMP 5 methodology, validation lifecycle processes, and experience with automation and control systems. This is an onsite position based in Bloomfield, Indiana. Roles & Responsibilities: Execute and manage com

Full-time

CSV Engineer

Newark, Delaware

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5d ago

Job Summary: We are looking for a Computer System Validation (CSV) Engineer to support our client in Newark, DE. In this role, you will be responsible for ensuring that computerised systems used in regulated environments are validated and compliant with industry standards. You will work closely with IT, Quality, and business teams to support validation activities and maintain system compliance throughout its lifecycle. Roles & Responsibilities: Lead and support CSV activities for GxP systems, in

Full-time

Sr. CSV Engineer

Chesterbrook, Pennsylvania

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5d ago

Job Summary: Seeking a Sr. CSV Engineer with 10+ years of experience in pharmaceutical compliance, Computerized System Validation (CSV), and GxP-regulated environments. The ideal candidate should have expertise in compliance regulations including 21 CFR Part 11, GxP, GAMP 5, SOX IT, Quality Management, Document Management, and Change Management. Experience with testing tools such as Client-ALM, JIRA, X-Ray, Agile methodologies, and exposure to global delivery models is required. Roles & Res

Full-time

CSV Engineer

Pennsylvania

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5d ago

Job Summary: The CSV Engineer / Validation Engineer will be responsible for ensuring computerized systems in a regulated pharmaceutical environment comply with GxP, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX requirements. The role involves supporting validation activities using a risk-based approach aligned with CSA principles, ensuring systems are audit-ready, and maintaining compliance throughout the system lifecycle. The position also requires hands-on involvement in documentatio

Full-time

Senior Computer System Validation (CSV) Lead Consultant - Concord, NC (Onsite)

Concord, North Carolina

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2d ago

Position Title: Senior Computer System Validation (CSV) Lead Consultant Location: Concord, NC (Onsite) Duration: 12 Months Job Summary Experienced Senior Computer System Validation (CSV) Consultant to support validation and compliance activities for MES and other GMP-regulated systems within the pharmaceutical/life sciences environment. The ideal candidate should possess strong expertise in Computer System Validation (CSV), IT Governance, and Compliance, with hands-on experience valida

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Contract, Third Party

Depends on Experience

CSV Engineer

New Jersey

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5d ago

Summary: IT CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role will focus on validating ERP Master Data Governance processes and Data Lake platforms, ensuring compliance with regulatory requirements and data integrity standards. Roles & Responsibilities: Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems Support validation activities fo

Full-time

LabVantage LIMS Consultant / Developer

Indianapolis, Indiana

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5d ago

LabVantage LIMS Consultant / DeveloperIntroduction: We are seeking an experienced LabVantage LIMS Consultant/Developer to support implementation, enhancement, integration, and support activities for enterprise laboratory systems within regulated environments. The ideal candidate should have strong experience with LabVantage LIMS, laboratory workflows, system integrations, data migration, and compliance standards such as GxP and FDA 21 CFR Part 11. Responsibilities:Serve as the LabVantage LIMS fu

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Third Party, Contract

60 - 65

Validation Engineer

Wisconsin

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5d ago

Summary : We are seeking an experienced Validation Engineer to support pharmaceutical manufacturing and quality operations in Washington. The ideal candidate will have hands-on experience in equipment, process, cleaning, and computerized system validation within a GMP-regulated pharmaceutical environment. This role requires strong knowledge of validation lifecycle activities, regulatory compliance, documentation, and cross-functional collaboration. Roles & Responsibilities : Execute and support

Full-time

Trackwise Digital SME

Remote

•

6d ago

Job Title: TrackWise Digital SME Experience: 1012+ Years Location: Remote Job SummarySeeking an experienced TrackWise Digital SME to lead administration, configuration, validation, and enhancement of the TrackWise Digital platform in a GxP-regulated environment. Key Skills46+ years of hands-on TrackWise Digital experienceTrackWise Administration, Configuration & ValidationCAPA, Deviations, Change Control, Workflow ConfigurationGxP, GMP, FDA, 21 CFR Part 11 ComplianceValidation Lifecycle (IQ/OQ/P

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Contract

70 - 80

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21 CFR Part 11 jobs