21 CFR Part 11 jobs

Senior Data Architect, Integrated Data Platform

San Francisco, California

•

3d 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

Tulip MES Implementation Engineer

Hybrid in Indianapolis, Indiana

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4d ago

Senior Implementation Engineer Tulip MES Location: Opening 1: Indianapolis, Indiana (Onsite) Opening 2: Global Consultant (Travel required to Kansas City, MO; Winslow, ME; and Iowa locations) Duration: 6 Months Contract (Possible Extension) Experience: 8 10+ Years Domain: Pharmaceutical / Biotech / Animal Health Manufacturing Job Summary: We are seeking a Senior Implementation Engineer with strong Tulip MES experience to design, configure, integrate, validate, and deploy digital manufacturing s

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Contract

$50 - $60

MES Engineer (Tulip)

Hybrid in Indianapolis, Indiana

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2d ago

Job Title : MES Implementation Consultant (Tulip) Location : Indianapolis, Kansas City, Winsow Maine and Iowa (Hybrid) Duration : 12+ Months Contract Experience: 8 10+ Years Domain: We are seeking a Senior Implementation Engineer Tulip MES to design, configure, and deploy digital manufacturing solutions across global pharmaceutical production facilities.Role Summary We are seeking a Senior Tulip MES Implementation Consultant to design, implement, and support Tulip-based MES solutions across pha

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Contract

Depends on Experience

Business Analyst Clinical Data

Morrisville, North Carolina

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26d ago

Skills / Experience Only for locals from NC. This a Business Analyst Clinical Data Management (CDM) only applicable for this position. Business Analysis for regulated environments (Life Sciences, Pharma, Healthcare, Clinical Data Management, Biostatistics). Proven ability to gather, document, and validate requirements; conduct workshops; create functional specifications; ensure compliance with FDA 21 CFR Part 11, GxP, HIPAA Knowledge of regulatory frameworks including 21 CFR Part 11, GxP, HIPAA,

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Full-time

Depends on Experience

Senior Data Architect, Integrated Data Platform

San Francisco, California

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2d ago

Senior Data Architect, Integrated Data Platform Location: San Francisco Bay Area, CA Contract position Role Overview: Client is seeking a 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 stud

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Contract, Third Party

Depends on Experience

Sr. Computerized System Validation (CSV) Manager

Remote

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17d 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

Digital Transformation Project Manager

Vacaville, California

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2d ago

Digital Transformation Project Manager Duration: 6 - 12 months/Onsite role / Hybrid is likely okay, but final decision is with Manager Location Vacaville, CA Lead and manage digital transformation projects across IT, manufacturing, and business functions at clients.Define project scope, timelines, budgets, and deliverables while ensuring successful execution.Coordinate with cross-functional teams, stakeholders, vendors, and global business units.Drive Agile project management practices, risk

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Third Party, Contract

Depends on Experience

Business Analyst - Healthcare with ETQ CAPA Experience

Hybrid in Atlanta, Georgia

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10d ago

Job Title: Business Analyst - Healthcare with ETQ CAPA Experience Location: Atlanta, GA (Hybrid) Experience: 5+ years Job Overview: Value Technology is seeking a highly motivated and experienced Business Analyst to join our team. In this role, you will be responsible for analyzing business requirements, documenting processes, and implementing solutions within the healthcare industry, with a specific focus on ETQ Reliance CAPA (Corrective and Preventive Action) processes. The ideal candid

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Full-time, Third Party

Depends on Experience

SAS Viya Developer

Raleigh, North Carolina

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2d 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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Third Party, Contract

$60

Validation Engineer

Boulder, Colorado

•

Today

Job Description Responsible for the execution of all qualification/validation activities, excluding process validation, at the Active Pharmaceutical Ingredient (API) manufacturing sites of Agilent Technologies Nucleic Acid Solutions Division. Generating and reviewing validation study documentation including validation plans, change controls, protocols, requirements specifications, asset induction requests, commissioning documentation, final reports and addenda while ensuring compliance with cG

Full-time

USD 103,200.00 - 161,250.00 per year

Principal Automation Engineer

Frederick, Colorado

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Today

Job Description Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent's Advanced Therapeutics Division is a contract development and manufacturing organization providing products and services for our clients that provide medicines for many indications improving health for patients. Agilent enables customers to gain the a

Full-time

USD 146,640.00 - 229,125.00 per year

Senior Full Stack Software Engineer

New Castle, Delaware

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Today

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

CSV Consultant

Remote

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3d ago

Role: CSV ConsultantLocation: Remote in USA (EST, CST preferrable)Experience: 5-10 yearsACSV Consultantis responsible for validating computerized systems used in regulated industries such as pharmaceuticals, biotechnology, healthcare, and medical devices to ensure compliance with regulatory requirements (FDA, GxP, 21 CFR Part 11).Key ResponsibilitiesPrepare and review validation documents (URS, FS, DS, IQ, OQ, PQ).Perform risk assessments and validation testing.Ensure compliance with FDA, GxP, a

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Contract

40 - 45

SAP QM Validation Analyst

Piscataway, New Jersey

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Today

Job Summary Location: Northeast US Experience: 3+ years in SAP QM Job Type: Contract (6-9 months) Thinking Minds' client is looking for an experienced SAP QM Validation Analyst to support the validation of their Quality Management System and SAP implementation. This role is crucial for ensuring compliance with regulatory standards like 21 CFR Part 11 and GxP. The analyst will work closely with Quality, IT, and business functions to deliver validation artifacts and maintain the validated state o

Contract

Validation Engineer

Waltham, Massachusetts

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Today

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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Today

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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Today

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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Today

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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Today

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

Empower CDS Administrator/Specialist

Remote

•

2d ago

Role: Empower CDS Administrator/SpecialistLocation: New Jersey // Pennsylvania (local)Experience: 7+ yearsJob DescriptionKey Responsibilities:Providetechnical expertisein Empower and other Chromatography Data Systems (CDS).Maintain and support current CDS systems, ensuring system stability and high availability.Troubleshoot and resolve end-user issues promptly.Administer CDS systems, includingserver maintenance, user management, and security controls.Performbackup, archival, restoration, and per

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Contract

40 - 45

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21 CFR Part 11 jobs