21 CFR Part 11 jobs

Hybrid in San Francisco, California

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6d 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

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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Third Party, Contract

Depends on Experience

MES Business Analyst

Hybrid in Indianapolis, Indiana

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12d ago

MES Business Analyst Location: Hybrid, Indianapolis, IN Responsibilities Elicit and document business, functional, and non functional requirements from shop floor, manufacturing, quality, warehouse, and supply chain stakeholdersTranslate business and shop floor requirements into functional solution designs, balancing usability, compliance, and maintainabilityDevelop process maps (as is / to be), user stories, data mapping specifications, and acceptance criteriaPerform fit gap analysis between ma

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Contract

Depends on Experience

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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Contract, Third Party

Depends on Experience

Manufacturing Data Strategy & Architecture Consultant

Remote

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22d ago

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

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Full-time, Third Party

Depends on Experience

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

DeltaV Automation Engineer (Biotech/Pharmaceutical)

Raleigh, North Carolina

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26d 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

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

Sr. Manager, Interactive Response Technology

Novato, California

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13d ago

Description: (remote) The Client is engaging a hands-on Interactive Response Technology (IRT) Lead to own the design, build, implementation, and lifecycle management of IRT/RTSM (randomization and trial supply management) systems across Phase IIV clinical trials, including the integrations that connect them to adjacent clinical and enterprise platforms. This is an individual contributor engagement: the person in this seat does the work, rather than directing a team that does it. The role sits

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Contract, Third Party

$65 - $75

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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Today

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

Digital Eng, Robotics & Automation, Process Sciences, Analytics and Technology, CGT

Los Angeles, California

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Today

We are seeking a Engineer, Digital and Data Science - Robotics and Automation within Process Sciences, Analytics and Technology, Cell and Gene Therapy. This engineer role will execute software, data, systems-integration, and digital-connectivity work required to develop and operate advanced robotic and automation platforms supporting AZD0120 and future cell and gene therapy programs. This engineer will build and support reliable interfaces, reusable software components, data pipelines, workflow

Full-time

USD 90,024.00 - 135,036.00 per year

CQV Engineer

Portland, Maine

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4d 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

CQV Engineer

Atlanta, Georgia

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4d 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

CSV Validation Engineer

Plymouth, Minnesota

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4d 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

CSV Validation Engineer

Jacksonville, Florida

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4d ago

Full-time

Sr. Computer Systems Validation Analyst

Foster City, California

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4d 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 prot

Full-time

Sr. Computer Systems Validation Analyst

Foster, California

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4d ago

Full-time

SAP Validation

Remote

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13d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

Sr Technical Writer

Remote

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7d ago

Hi, Hope you are doing well. Job Title: Sr IT Technical Writer Location: Remote Duration:12+ Months Job Description: We areseeking a Senior IT Technical Writer with 10+ years of experience to support technical documentation initiatives within a Bio-Pharma/Life Sciences environment. The consultant will work closely with IT, engineering, application, infrastructure, quality, validation, and business teams to develop accurate and compliant documentation for regulated systems. The role involves cr

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Contract

Depends on Experience

CQV Engineer

Concord, North Carolina

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4d 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

IT Lab Support

Cambridge, Massachusetts

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10d ago

IT GxP Lab Computing Engineer The Lab Computing Engineer provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal support tea

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Contract

$45 - $50