21 cfr jobs in bell gardens, ca

Remote

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3d ago

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

Technical Program Manager

Bell Gardens, California

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28d ago

Payrate: $90.00 - $100.00/hr. Responsibilities:Release Program Leadership:Manage deliverables to completion for Companys FDA approved Hearing Correction feature - software as medical device (SaMD) in accordance with Quality Management System (QMS) software release process end-to-end: define release scope, schedule, and milestones.Maintain a single source of truth for release status, dependencies, risks, and open items across all functions.Cross-Functional Coordination:Coordinate release activit

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Contract, Third Party

$90 - $100

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

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

Engineer II

Irvine, California

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14d ago

Job Description: We are seeking a Systems Engineer II to join a Device and Combination Product Development - R&D team. The engineer will contribute to the development and launch of innovative drug-device combination products. The role will integrate multiple engineering disciplines to support robust, safe, compliant, and patient-focused product design and performance. Responsibilities: Develop and maintain Design History Files (DHF) and Design Control documentation in compliance with applicable

Full-time

Mechanical Engr 3

Irvine, California

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Today

Job Title: Mechanical Engr 3Location: Irvine, California 92618 - OnsiteDuration: 06 Months ContractNO OVERTIME planned/required6-month assignment due to budgetary concerns, may extend to 1yr or more depending on project scope, details, and assignment needs.Description:The Electro-Mechanical LCM Engineer is an exciting opportunity to collaborate on projects and initiatives in support of Advanced Patient Monitoring (BD APM) systems. This position will play a key role in the development and executi

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Contract

Depends on Experience

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

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

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

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

SAP Validation

Remote

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23d 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

CSA/CSV Validation Consultant

Remote or Arlington, Virginia

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Yesterday

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

PLM Windchill Solution Architect/ SME

Remote

•

Yesterday

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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9d 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

Computer Vision Engineer

Remote

•

Yesterday

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

Windchill Solution Architect

Remote

•

Yesterday

Job Description: Summary Seeking an experienced Windchill PLM SME to assess the current PTC Windchill landscape and define the upgrade strategy and roadmap for Windchill 2027. Preference for candidates with a strong Medical Devices background; Life Sciences and Healthcare experience will also be considered. Responsibilities Assess existing Windchill configuration, customizations, workflows, data models, infrastructure, and integrations.Evaluate Windchill 2027 readiness, upgrade risks, technical

Contract

$100 - $130

PLM Windchill Solution Architect

Remote

•

Today

We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for a future upgrade to PTC Windchill 2027. The ideal candidate will possess deep technical expertise in Windchill, strong business process knowledge, and a proven track record of PLM transformation programs within Life Sciences, Healthcare, or Medical Device organizations. The consultant will evaluate the current Windchill implementation landscape, review customizations an

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Full-time

Depends on Experience

Product Owner

Remote

•

17d 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

21 cfr jobs in Bell Gardens, CA 90201, USA