21 cfr part 11 jobs in laguna beach, ca

Laguna Beach, California

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9d ago

HonorVet Technologiesis 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 are headed and only reach out when we genuinely believe there's a fit worth exploring. I came across your profile, and

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Contract

$26 - $33.85

Computer System Validation (CSV) in life sciences

Remote

•

Today

Validation Lead Wilmington, DE (Onsite / Hybrid) Computer System Validation (CSV) in life sciences R&D is a structured process that proves software and automated systems consistently perform as intended while meeting regulatory standards like GxP, 21 CFR Part 11, and GAMP 5.

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Contract, Third Party

45 - 50

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

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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11d 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

Senior Validation Engineer

Costa Mesa, California

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Today

Senior Validation Engineer - Lead Hands-On GMP Validation for Critical Pharmaceutical Manufacturing Systems This Jobot Job is hosted by: Robert Donohue Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $125,000 per year A bit about us: We are a growing life sciences organization focused on delivering high-quality products within a highly regulated GMP manufacturing environment. Our team is committed to quality, compliance, continuo

Full-time

USD 115,000.00 - 125,000.00 per year

Sr. Engineer, Operational Technology

Tustin, California

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Today

Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Senior Engineer, Operational Technology leads the technical design, planning, implementation, administration, and support of enterprise systems, manufacturing equipment, and laboratory instr

Full-time

USD 93,600.00 - 117,000.00 per year

Sr. Engineer, GxP Systems

Tustin, California

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Today

Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Senior Engineer, GxP Systems leads the technical design, planning, implementation, administration, and support of enterprise systems, manufacturing equipment, and laboratory instrumentation

Full-time

USD 93,600.00 - 117,000.00 per year

Application Developer, Business Systems

Irvine, California

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Today

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) business's AI, Product and Platforms organization is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It is our driving force to help patients

Full-time

USD 87,000.00 - 123,000.00 per year

Senior Validation Engineer

Costa Mesa, California

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Today

This Jobot Job is hosted by: Christian Aviles Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $110,000 - $125,000 per year A bit about us: We're a growing contract development and manufacturing organization that partners with biopharmaceutical companies from early-stage process development through commercial manufacturing. Why join us? This is an opportunity to join a growing organization where your work will have a direct impact on the co

Full-time

USD 110,000.00 - 125,000.00 per year

Staff Data Engineer

Irvine, California

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Today

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description Summary: As a Staff Data Engine

Full-time

USD 161,400.00 - 258,200.00 per year

Envista Manager, IT ERP - Oracle Manufacturing (Brea/Irvine, CA)

Brea, California

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Today

Job Description: JOB SUMMARY: Envista is looking for a Manager, IT ERP - Oracle Manufacturing to lead the functional health, integrity, and strategic roadmap of our global Oracle E-Business Suite Manufacturing platform. This hands-on leadership role will manage internal and managed-service partner resources while serving as the organization's lead functional expert for Oracle Manufacturing. The position will partner closely with Operations and IT stakeholders to deliver scalable solutions, res

Full-time

USD 164,300.00 - 190,000.00 per year

SAP Validation

Remote

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24d 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

Veeva Migration Consultant

Remote

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Today

We are looking for 3 strong profiles with hands-on Veeva migration experience. We need candidates who can demonstrate: Hands-on migration of clinical trial data/documents to Veeva, including source-to-target mapping, transformation, cleansing, loading, and reconciliation.Experience with regulated clinical platforms such as CTMS/eTMF/EDC and migration controls covering audit trails, metadata, data integrity, and GxP/21 CFR Part 11 expectations.Experience executing mock/test/production migration c

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Contract, Third Party

Depends on Experience

Veeva Migration Consultant

Remote

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Today

Role: Veeva Migration Consultant Location: 100% Remote Role Summary: Hands-on migration of clinical trial data/documents to Veeva, including source-to-target mapping, transformation, cleansing, loading, and reconciliation.Experience with regulated clinical platforms such as CTMS/eTMF/EDC and migration controls covering audit trails, metadata, data integrity, and GxP/21 CFR Part 11 expectations.Experience executing mock/test/production migration cycles, handling migration defects, and supporting

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Contract, Third Party

$40,000 - $60,000

CSA/CSV Validation Consultant

Remote or Arlington, Virginia

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Today

Role - CSA/CSV Validation Consultant Remote Skills & Experience Required: empower or similar HPLC software Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain Familiarity with QMS processes including deviation management, CAPA, and change control. Strong command of CSA (Computer Software Assurance) principles Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+). Proven ability to write and manage valida

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Contract

PLM Windchill Solution Architect/ SME

Remote

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Today

Position SummaryWe are seeking a highly experienced Windchill PLM Subject Matter Expert to assess the current PTC Windchill environment and develop a strategic upgrade roadmap for Windchill 2027. The ideal candidate will have strong technical and functional expertise in Windchill, PLM transformation, system upgrades, data migration, and integrations within regulated industries, preferably Medical Devices. Key ResponsibilitiesAssess the existing Windchill environment, including configurations, cu

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Contract, Third Party

Depends on Experience

Product Owner

Remote

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10d ago

Role OverviewThe Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution.This role blends product management discipline with deep understanding of regulated clinical workflows, ensuring the platform delivers measurable value to sponsors, CROs, research sites, and patients. The PM drives feature development across study startup, patient identification, eligibility, randomiz

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Contract, Third Party

$80 - $85

PLM Windchill Solution Architect/ SME

Remote

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2d ago

Role : PLM Windchill Solution Architect/ SME Location : Remote Type : Contract Required Skills & Experience Windchill Expertise 12+ years of hands-on experience with PTC Windchill. Expertise across: Windchill PDMLink ProjectLink MPMLink PartsLink Change Management Document Management Configuration Management Strong knowledge of Windchill versions 12.x/13.x and roadmap toward Windchill 2027. Experience with Windchill upgrades, migrations, and modernization programs. Technical Skills

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Contract, Third Party

Depends on Experience

Product Owner

Remote

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18d ago

Iris's direct client, a leader in Healthcare services, looking to hire a strong Product Owner for a Long-Term Contractual role Job title: Product Owner Location: 100% Remote Duration: 18 Months Skills: Product Owner, Clinical Trial Platform Job Description: Product Manager Clinical Trial Platform Role Overview The Product Manager for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end-to-end clinical trial executio

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Contract

Depends on Experience

Computer Vision Engineer

Remote

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2d ago

Role: Computer Vision EngineerLocation: Remote with travel required 50%Duration: 6months with possible extensionRole OverviewWe are seeking a Computer Vision Engineer to own the development and integration of real-time automated visual inspection systems for our pharmaceutical packaging lines. In this role, you will design and deploy edge-based vision models that interface with high-speed cameras and IoT hardware to detect packaging defects, verify serialization, and ensure 100% quality complian

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Contract

Depends on Experience

21 cfr part 11 jobs in Laguna Beach, CA, USA