21 CFR Part 11 jobs

Boston, Massachusetts

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2d ago

Job Title: Process Validation Engineer Company: Prowise Solutions Location: Boston, MA (Onsite 5 Days/Week) Employment Type: W2 Only Duration: 12 Months Contract with possible extension. Rate: $55 to $60/hr on W2. Job Description Prowise Solutions is seeking an experienced Clinical Systems / GxP Compliance Consultant to support a leading client in the Pharma/Life Sciences domain. This role requires strong expertise in regulatory compliance and validation to ensure systems remain audit-ready and

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Contract

$55 - $60

VeevaVMS Consultant (W2 Contract) (Remote)

Remote

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5d ago

We are seeking a highly skilled VeevaVMS Consultant to lead the end-to-end implementation of Veeva s Verification Management System. This is a critical, client-facing role requiring a blend of technical expertise, business analysis, and deep domain knowledge in the Life Sciences industry. You will be responsible for bridging the gap between complex business requirements and technical execution, ensuring that our clients can effectively manage verification, quality, and compliance data within the

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Contract

Depends on Experience

Oracle Cloud/Fusion SCM Functional Consultant

Hybrid in Toronto, Ontario

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13d ago

Title: Oracle Cloud/Fusion SCM Functional Consultant Location: Toronto, Canada - Onsite/Hybrid Modules: Procurement and Manufacturing Position: Type: Contract (40 hours per week) This is not a configuration-heavy consulting role. The ideal candidate brings deep SCM/Mfg. Business and Oracle Fusion functional knowledge, the instincts of a seasoned super-user, and the domain fluency to operate effectively within a GxP-regulated environment. This individual will serve as the eyes and ears of the ERP

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Contract, Third Party

$80 - $90

Sr. Computerized System Validation (CSV) Manager

Remote

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10d 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

Technical Lead

Smyrna, Georgia

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3d ago

A senior-level Technical Lead role responsible for managing and supporting patient support solutions within the healthcare and pharmaceutical sectors. This position involves leading technology projects, collaborating with internal teams and external partners, and overseeing the deployment and maintenance of technical systems to enhance patient experience programs. The role requires strategic oversight, technical expertise, and stakeholder engagement to drive successful project outcomes and syste

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Full-time

Depends on Experience

Sr. Validation Analyst

Remote

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25d ago

<>General SummaryThe Senior Validation Analyst leads strategic validation initiatives to introduce new GxP technologies at Southern Research. From technology assessment and procurement through planning, validation, operational support, and eventual retirement, this role owns validation deliverables and ensures systems remain in a validated state throughout their lifecycle. This position collaborates with the Business, Application Administrators, Information Technology, and internal Quality teams

Full-time

Depends on Experience

Clinical Data Specialist

Hartford, Connecticut

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Today

Responsibilities: Reporting to the Clinical Data Manager, you'll be responsible for the development of real-world data variables from structured and unstructured data sources, including designing data capture forms and supplemental procedures to instruct the abstraction process You'll lead the execution of feasibility testing to de-risk data capture approaches, and own the implementation of data validation checks to ensure data quality In addition, you'll work alongside other team members on way

Full-time

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

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

ServiceNow Architect / Process Owner

Lebanon, Indiana

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Today

Job Title: ServiceNow Architect / Process Owner Location: Lebanon, Indiana (Onsite) Job Type: Contract Domain: Life Sciences & Pharma Job Overview We are seeking an experienced ServiceNow Architect / Process Owner to lead the design, implementation, and governance of the ServiceNow platform within a highly regulatedGxP/GMP environment. This role will be responsible for driving CMDB architecture, workflow automation, system integrations, and ensuring compliance with industry regulations inclu

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Full-time, Contract

CSV Engineer

New Jersey

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Today

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

ServiceNow Process Owner

Lebanon, Indiana

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3d ago

Job Title: ServiceNow Process OwnerLocation: Lebanon, IndianaDuration: 12+ month ContractJOB DESCRIPTION:Mandatory skills:Demonstrated experience as a ServiceNow Process Owner, Administrator, or Architect in a regulated (GxP/GMP) environment.Deep knowledge of ITIL best practices across Incident, Problem, Change, Knowledge, and CMDB modules.Experience designing CMDB architecture and CI relationship models for industrial/manufacturing automation systems.Proficiency in ServiceNow configuration, wor

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Third Party, Contract

Depends on Experience

ServiceNow Process Owner_Onsite@Lebanon,Indiana

Lebanon, Indiana

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3d ago

Role: ServiceNow Process Owner Location: Lebanon, Indiana Onsite Contract Domain: Life Sciences & Pharma Experience: 7-10 years Job Description: Serve as the dedicated owner for ServiceNow module design, configuration, and governance across the Automation Department.Architect the CMDB structure for automation systems, define CI relationship models, and establish data quality standards.Design and configure Incident, Problem, Knowledge, and Change Management workflows.Establish integration archit

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Contract

Depends on Experience

Sr. Validation Engineer

San Diego, California

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3d ago

Only local candidates! No 3rd party agencies! Direct W2 contractors only! No Visa sponsorship available! Start date: 04/03/2026 Duration: 6 months Global biotech company is looking for a Sr. Validation Engineer for their location in San Diego. Please contact me for more details. Skills required: 7 10 years validation experience in a regulated pharmaceutical environment. Equipment Qualification: Full lifecycle IQ/OQ/PQ and periodic reviews. Thermal Mapping: Experience with temperature mapping (

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Contract

$70 - $72.46

ServiceNow Process Owner

Lebanon, Indiana

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2d ago

Serve as the dedicated owner for ServiceNow module design, configuration, and governance across the Automation Department.Architect the CMDB structure for automation systems, define CI relationship models, and establish data quality standards.Design and configure Incident, Problem, Knowledge, and Change Management workflows.Establish integration architecture between ServiceNow and DeltaV, PI Historian, Rockwell, CyberArk/AD, and reporting platforms.Deploy automated access request forms and role-

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Contract

Depends on Experience

CSV Engineer

Pittsburgh, Pennsylvania

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Today

Job Summary: CSV Engineer to support commissioning and validation activities for a newly built Cell & Gene Therapy R&D and manufacturing facility in Pittsburgh, PA. The role focuses on reviewing validation deliverables, ensuring compliance with regulatory standards (21 CFR Part 11, GAMP 5), and coordinating with commissioning teams handling facilities, utilities, MES, EMS, CMMS, and related systems. The consultant will work within environments using Kneat, Microsoft Office, and automation platfo

Full-time

LabVantage LIMS Engineer

Remote

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3d ago

Provide L2/L3 incident resolution for LIMS applications (LabVantage or LabWare). Diagnose and resolve configuration issues, workflow errors, sample lifecycle problems, and data inconsistencies. Conduct detailed root-cause analysis and implement permanent fixes. Maintain LIMS master data, workflows, templates, and stability modules. Support version upgrades, patches, and environment maintenance. Assist laboratory users with operational questions, access issues, and data troubleshooting. Support i

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Third Party, Contract

Depends on Experience

ServiceNow Product Owner

Lebanon, Indiana

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3d ago

ClifyX group is an award winning IT Consultancy formed in 1998. Our Mission is to provide our clients with Optimal Technology solutions that are effective and within budgets. We specialize in helping Organizations to review their strategic SOW Projects/Talent needs and implement high value and cost effective solutions to increase profitability and efficiency. Our consulting capabilities include expertise in Cloud, Artificial Intelligence, Data Analytics and compliance aspects of Cyber Security d

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Contract

Depends on Experience

Manufacturing Quality Engineer

San Diego, California

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17d ago

5 to 6 years of medical devices or diagnostic equipment manufacturing experienceManage the end-to-end validation documentation lifecycle including authoring, reviewing and approving protocols (URS, IQ, OQ, PQ, PV, TMV, RTM, VSR) Change Controls and Periodic Reviews, ensuring alignment with site VMP and ISO 13485.Lead cross-functional validation initiatives for lab equipment, facilities, and non-product software supporting diagnostics platformsQualify GXP equipment in compliance with FDA 21 CFR P

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Contract, Third Party

$38 - $40

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21 CFR Part 11 jobs