21 CFR Part 11 jobs

Hybrid in Raritan, New Jersey

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Today

Job Details: 8 to 10 yrs in medical devices, biotechnology with direct CSV exp Practical knowledge of GxP regulations and standards 21 CFR part 11, Part 210/211, GAMP 5, EU Annex 11, security and privacy requirements Exp in leading GxP infrastructure qualification and quality oversight of on prem or cloud environments with working knowledge of networks, databases, virtualization, ITIL process, disaster recovery and infrastructure security controls Exp with Jira/Xray, qtest or equivalent ALM

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Contract, Third Party

Depends on Experience

Lab Project Manager(W2 Role)

Boston, Massachusetts

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11d ago

No C2C or agency resumes, please. Please do not enquire or submit candidates if you are an agency or if the candidate is available on a C2C basis. Role: Lab Systems Project Manager Benchtop Systems Location: Boston, MA (Onsite) Duration: Contract Job Description: Seeking an experienced Lab Systems Project Manager with 712+ years of experience managing benchtop laboratory systems implementation, integration, validation, and lifecycle management in pharmaceutical, biotech, or diagnostics environm

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Contract

Depends on Experience

Validation Lead– CoreAI

San Francisco, California

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6d ago

Title: Validation Lead CoreAI Location: San Francisco, CA We drive and realise cell and gene therapies by translating scientific progress into life-changing experiences for patients. Global Reputation for industry-leading contributions Cell and Gene Therapy powerhouse at Roche Driver of life-changing treatment for patients Talent destination and incubator Partner of choice and Pioneer in a new era in medicine About the role: In Pharma Technical Operations (PT), Roche is advancing a cutting-

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Contract

Depends on Experience

Loftware Spectrum Technical Lead

Remote

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Today

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

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Contract, Third Party

Depends on Experience

Windchill Solution Architect/Senior Windchill PLM Consultant Medical Device Industry

Remote

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13d ago

Position Title: Windchill Solution Architect/Senior Windchill PLM Consultant Experience: 12+ Years Location: Flexible / Hybrid Domain: Medical Devices (additionally we can look at candidates from Life Sciences, Healthcare domain as well but preference shall be for candidates with Medical Devices domain background) Employment Type: Full Time / Contract Position Summary We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for a

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Contract, Third Party

80 - 90

TIBCO Statistica specialist

Vacaville, California

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Today

We are currently seeking a Statistical Software Configuration Specialist (Statistica TIBCO) for a 612+ month contract based in Vacaville, CA. This role follows a balancing data analytics work with on-site manufacturing support and collaboration. Position Overview: The Statistical Software Configuration Specialist is responsible for configuring, optimizing, and maintaining the TIBCO Statistica platform to support enterprise-level analytics, workflow automation, and data-driven decision-making. T

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Contract, Third Party

Depends on Experience

CQV Validation Specialist

Bend, Oregon

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Today

CQV Validation Specialist Location: Bend, OR (Onsite) Duration: 6-9 Month Contract Schedule: Full-time, onsite Interview Process: Initial Teams interview followed by a panel interview (Teams or onsite; onsite may be required). Hiring Manager Notes Immediate need due to a significant CQV validation backlog. Strong preference for candidates with analytical laboratory experience. Must be comfortable balancing priorities between CQV and Instrumentation teams. Onsite presence in Bend is requir

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Contract, Third Party

Depends on Experience

Core Java and Full Stack Application Developer QMS Developer

Sunnyvale, California

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13d ago

Job Title : Senior AI Software Engineer QMS Developer Location : Sunnyvale, CA - Fully onsite (5 days) Duration :1 year W2 Candidate Only Top Skills: Strong core Java and full-stack application development in validated GxP environments (Spring Boot, REST APIs, SQL, modern front-end framework)Python-based AI engineering LLM application and agent development (RAG, prompt engineering, orchestration, evaluation)AWS solution architecture for AI and application workloads (Bedrock/SageMaker, Lambda,

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Contract

80 - 85

GxP Systems Analyst, Operational Technology

North Carolina

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Today

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop

Full-time

Computer Systems Validation Engineer

Boston, Massachusetts

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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

Document Control Specialist

Warsaw, Indiana

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6d ago

Job SummaryWe are seeking an experienced Senior Document Control & Records Management Specialist to lead document control and records management activities. This role is responsible for ensuring documents and records are accurately processed, maintained, retained, and updated. The individual will provide guidance to team members, manage change control activities, support daily department operations, and drive process improvements. Key ResponsibilitiesSupport the department supervisor in managin

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Contract

23 - 26

MES Architect (Scada, MQTT, ISA)

Jacksonville, Florida

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Today

Serving as a technical architect and consultant for a leading Contact Lens manufacturer, delivering automation and digital transformation solutions in a highly regulated medical device environmentLeading team of 15+ onsite and offshore engineers, acting as technical mentor, and primary customer point of contact for automation and controls projectsLed shopfloor-to-MES integration using platforms aligned with ISA-95 standards to ensure structured data modeling and seamless vertical integrationLed

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Third Party, Contract

Depends on Experience

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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5d 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)

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Third Party, Contract

$80 - $90

Systems Engineering Specialist

Boulder, Colorado

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14d ago

Payrate: $54.79 - $54.79/hr Summary: As an Advanced/OT Operation & Infrastructure Professional, you will serve as the first point of contact for the Boulder site regarding any IT equipment or IT system related issues. You will collaborate with suppliers and global teams to resolve these issues efficiently. Additionally, you will be responsible for managing IT-related compliance needs and documentation for projects, ensuring all requirements are met and maintained. Responsibilities:Manage and Ma

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Contract

$54.79 - $54.79

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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28d ago

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing

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Contract

Depends on Experience

Validation Engineer

Jersey City, New Jersey

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6d ago

Summary: The Validation Engineer will support GMP validation activities and equipment qualification in a pharmaceutical or life sciences environment. The role involves developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, reviewing validation documentation, preparing reports, and supporting deviation investigations. The engineer will ensure compliance with cGMP, GAMP, 21 CFR Part 11, Good Documentation Practices (G

Full-time

Technical Architect ServiceNow

Newark, New Jersey

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Today

Job Title: Technical Architect ServiceNow Location: Somerset, NJ Job Description: Seeking an experienced ServiceNow Technical Architect to lead enterprise implementations, architecture, and transformation initiatives across ITSM, ITOM, ITAM (HAM/SAM), CMDB, and Discovery. Key Responsibilities: Lead end-to-end ServiceNow implementations, upgrades, migrations, and instance consolidations. Design ServiceNow architecture, custom applications, integrations, and orchestration solutions. Strong hands-

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CSV Validation Engineer

Jacksonville, Florida

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6d 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 computeri

Full-time

Sr. Computer Systems Validation Analyst

Foster, California

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6d 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

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6d ago

Full-time