21 CFR Part 11 jobs

SAP S/4HANA Validation SME Life Sciences / Pharma @ Foster City, CA _ Hybrid - Only on W2

Hybrid in Foster City, California

•

Today

SAP S/4HANA Validation SME Life Sciences / PharmaLocation: Foster City, CA _ HybridExperience: 10+ YearsDomain: Life Sciences & Pharma JD: 10+ years of experience in SAP validation / CSV, preferably within Life Sciences/Pharma.Strong experience validating SAP ECC and SAP S/4HANA applications.Experience creating, reviewing, and approving validation deliverables.Strong knowledge of CSV, 21 CFR Part 11, GxP, GAMP 5, SOX IT, Data Integrity, Data Privacy, Cloud, and Information Security.Develop risk-

Easy Apply

Contract

$60 - $70

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

•

7d ago

Job Title: GxP Project Manager Location: Bay Area, CA Duration: 6+ months with possible of extension Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.8+ years of Project Management experience within the Pharmaceutical or Biotechnology industry.5+ years managing GxP-regulated projects.Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11.Experience managing Computer System Validation (CSV)

Easy Apply

Contract, Third Party

$80 - $90

Clinical Life Science Data Hub Functional Architect

Remote

•

Today

Job Title: Clinical Life Science Data Hub Functional Architect Location: 100% Remote Rate: $70/hr on 1099 or C2C Visa: H1B,L2EAD,-EAD Experience: 15+ Years Overall | 5+ Years in Life Sciences / Clinical Trial Data Position Overview MiniMed is seeking a visionary Functional Architect to design, build, and govern a Clinical Life Science Data Hub on Databricks. This role sits at the intersection of clinical domain expertise and modern data engineering and is responsible for defining the end-to-end

Easy Apply

Third Party, Contract

$60 - $70

OT Security Architect----Bedford, MA -- candidates can work for any Client office--Hybrid

Hybrid in Bedford, Massachusetts

•

27d ago

OT Security Architect Bedford, MA -- candidates can work for any Client office Skills: OT--Hands on strong exp risk management pharmaceutical cyber Rockwell PL Ignition SCADA compliance with EU Cyber Resilience Act (CRA) IEC 62443/ISA99 ISA 95 GMP FDA 21 CFR Part 11 Certification--added advantage at least try for few IEC 62443 Cybersecurity Expert GICSP / CISSP Rockwell Automation Sirisha N Sr IT Analyst Humac Inc.

Easy Apply

Third Party, Contract

Depends on Experience

OCM Consultant - MDM

Hybrid in Fort Worth, Texas

•

5d ago

Title: Organizational Change Management Consultant - MDM Location: Fort Worth, TX (Hybrid- 3days onsite in a week) Position Overview TheOCM Leadwill drive the people, process, and culture strategy for our globalMaster Data Management (MDM)transformation. In the highly regulated medical device industry, data integrity directly impacts product quality, regulatory compliance, and patient safety. This role focuses on accelerating the adoption of new data governance policies, standardized workflows,

Easy Apply

Contract, Third Party

Depends on Experience

IT Business System Analyst I # 26-23641

Hollywood, Florida

•

4d ago

Duration: 14 months with possible extension Overview The IT Support Analyst will support local IT applications and serve as a key connection between IT and business operations within a pharmaceutical environment. This role will help manage applications, support validation activities, translate business needs into practical technical solutions, and collaborate with local and global teams to improve efficiency while meeting quality and regulatory requirements. Responsibilities Application Support

Easy Apply

Contract

$42 - $44

Manufacturing Data Strategy & Architecture Consultant

Remote

•

Yesterday

Job title: Manufacturing Data Strategy & Architecture Consultant Location: Remote Position Overview Seeking a senior Manufacturing Data Strategy & Architecture Consultant to support the development of a future-state data vision, strategy, and architecture roadmap. The ideal candidate will bring deep expertise in pharmaceutical manufacturing data ecosystems, industrial data architectures, contextualization, semantics, and GxP-regulated environments. This role will serve as a trusted advisor to Pf

Easy Apply

Full-time, Third Party

Depends on Experience

Sr. IT Project Manager

Remote

•

Today

We are seeking a Senior IT Project Manager with demonstrated experience leading complex, cross-functional technology initiatives in global and regulated manufacturing environments. The immediate priority for this role will be the delivery of projects involving Manufacturing Execution Systems, with a primary focus on the Critical Manufacturing MES platform. The successful candidate should also bring experience that can be applied across adjacent enterprise technology domains, such as SAP/ERP,

Easy Apply

Contract

60 - 65

Quality Data Management Analyst

Burlington, Massachusetts

•

28d ago

HonorVet Technologies is a Service Disable Veteran-Owned IT staffing firm, ISO 9001 and ISO 27001 certified, working with federal agencies, state governments, and Fortune 500 enterprise clients across the US. What makes us different isn''t a tagline; it''s the way we work. We don''t forward resumes and hope for the best. We take the time to understand where a professional like you is headed and only reach out when we genuinely believe there''s a fit worth exploring. Job Title: Quality Data Mana

Easy Apply

Contract

$48.56 - $53.36

Computer Systems Validation Engineer

Boston, Massachusetts

•

Today

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

DeltaV Automation Engineer (Biotech/Pharmaceutical)

Raleigh, North Carolina

•

4d ago

Title: DeltaV Automation Engineer (Biotech/Pharmaceutical) Location - Raleigh - Durham NC Various years of experience: 3 - 7 years /7 - 14 years/14+ years Candidates need to be local or willing to relocate to the areas of operation where we have open opportunities for immediate hire in the Raleigh - Durham NC area: Mandatory Skills: 3+ years of work experience with Emerson DeltaV 3+ years of work experience with DeltaV Responsibilities Design, configuration, integration and implementation of pr

Easy Apply

Full-time, Part-time, Third Party, Contract

Clinical Data Business Analyst

Alameda, California

•

2d ago

Clinical Data Business Analyst Biometrics & Data Engineering Role Overview This role is the connective tissue between Biometrics and Data Engineering. It exists because clinical data has meaning that structure alone doesn t carry: someone has to understand what the data represents clinically, what the standards require of it, and how it must therefore be modeled and then make sure the engineering team builds systems that produce it correctly. The SME owns that translation. They bring clinical

Easy Apply

Contract, Third Party

CQV Engineer

Atlanta, Georgia

•

3d 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

CQV Engineer

Concord, North Carolina

•

3d 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 valid

Full-time

CQV Engineer

Portland, Maine

•

3d 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. Author and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and val

Full-time

CSV Validation Engineer

Plymouth, Minnesota

•

3d ago

Summary: We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN. Roles & Responsibilities: Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports. Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports. Perform risk assessments, impact assessments, traceability, and change control activities. Support validation of GxP-regulated compu

Full-time

Sr. Computer Systems Validation Analyst

Foster, California

•

3d ago

Summary : We are seeking a Senior Computer Systems Validation (CSV) Analyst with strong experience in GxP-regulated pharmaceutical/life sciences environments. The candidate will be responsible for planning, leading, and executing validation activities for SCADA, Rockwell FactoryTalk, PLCs, and Ignition process control systems. The role requires hands-on expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, validation lifecycle documentation, risk assessments, change controls, and qualification pro

Full-time

Sr. Computer Systems Validation Analyst

Foster City, California

•

3d ago

Full-time

CSV Lead Consultant at Princeton, NJ (Hybrid, 3 days in Office) || W2 Only

Hybrid in New Jersey

•

Today

CSV Lead Consultant Princeton, NJ (Hybrid, 3 days in Office) Long Term Contract Mandatory Skills- Computer System Validation (CSV), GxP Systems & Compliance, Manufacturing Domain Knowledge, Labeling Systems Knowledge, Validation Testing (IQ/OQ/PQ) , Validation Documentation , FDA 21 CFR Part 11 / GAMP5 , Risk Assessment & Change Control , Stakeholder Management , Audit & Inspection Support Role Summary We are seeking an experienced Computer System Validation (CSV) Professional with strong exper

Easy Apply

Contract

Chromeleon System Administrator

Cincinnati, Ohio

•

Today

Role: Chromeleon System Administrator (L2/L3) Location: Cincinnati, OH (Onsite) Start: Immediate Type: Contract Interview: Phone/Video Summary: Provide L2/L3 support, development, and integration for Chromeleon CDS applications in pharma/life sciences. Work includes SDK customization, SQL/database development, system integration, incident resolution, and GxP compliance. Skills: Chromeleon CDS / Chromeleon SDK SQL (TSQL, Stored Procedures) LIMS Integration, REST APIs C#, .NET Framework/.NET C

Easy Apply

Full-time, Part-time, Third Party, Contract