jobs in irvine, ca, us

Irvine, California

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Today

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

Hardware Component Engineer

Irvine, California

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Today

Summary We are seeking a skilled and detail-oriented Hardware Component Engineer to join our engineering team. The ideal candidate will be responsible for the selection, qualification, lifecycle management, and technical support of electronic and electromechanical components used in hardware products. The role requires close collaboration with hardware design, sourcing, manufacturing, quality, and suppliers to ensure component reliability, availability, compliance, and cost optimization througho

Full-time

Component Engineer

Irvine, California

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Today

Responsibilities: DVT & Design Release Support. Participate in DVT readiness and design reviews to identify component risks, manufacturability concerns, and documentation gaps. Support design transfer activities to ensure readiness for manufacturing release. Component Risk & Lifecycle Assessment Evaluate lifecycle status (NRND/EOL), supplier risk, and availability Recommend alternates and mitigation strategies. Support Release of OTS and custom parts Mechanical Drawing Review & Manufacturability

Full-time

CQV Engineer

Remote or New Jersey

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Today

Summary : This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manuf

Full-time

RWE Programmer (SAS)

Remote or New Jersey

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Today

Job Summary: We are seeking an experienced Real World Evidence (RWE) Programmer with strong SAS, SQL, and R programming expertise to support observational research and healthcare data analytics initiatives for pharmaceutical and biotechnology clients. The ideal candidate will have hands-on experience working with large-scale healthcare claims and Electronic Health Record (EHR) databases, developing patient cohorts, and creating high-quality analysis datasets for real-world evidence studies. This

Full-time

MODA Systems Analyst

Remote or New Jersey

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Today

Job Description: We are seeking a high-level Lab Systems Administrator for a fully remote position to execute administration, maintenance, and master data activities specifically for the MODA platform in support of the Massachusetts Biologics Operations (MBO) site. This role maintains system workflows, handles instrument interfaces, provides first-tier remote end-user support, and coordinates closely with Global system owners regarding system changes and communications. All requests, issues, and

Full-time

Supplier Development Engineer

Irvine, California

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Today

Job Description : This role operates as a technical bridge between Engineering, Supply Chain, and Manufacturing to ensure that component selections and mechanical designs are robust, producible, and aligned with supplier capabilities prior to production release. The position is expected to identify and mitigate risks early, particularly in component selection, tolerancing, and manufacturability, to reduce downstream reliability issues, supply disruptions, and design rework. Roles & Responsibilit

Full-time

Medical Device V&V engineers

Remote or New Jersey

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Today

Summary: We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Roles & Responsibilities: Design Controls: Lead efforts to deve

Full-time

Tech 3, Mechanical Engineering

Brea, California

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Today

Job Description: We are seeking a Product Development Tech for our Brea, CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their contacts are primarily with immediate supervisor, project leaders, and other professionals in the unit. Duties and Responsibilities: Gathers, maintains, formats, compiles, and manipulates technical data, such as laboratory or material test results and engineering de

Full-time

Senior Automation Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Role requires a senior level automation engineer comfortable operating independently while supporting others. No CSV authorship responsibility: CSV activities are supported indirectly through automation execution and issue resolution. DeltaV DCS automation experience in pharmaceutical / biopharma manufacturing Strong troubleshooting and problem solving skills in live manufacturing environments, including commissioning, issue triage, and rapid resolution under GMP constr

Full-time

Tech 3, Mechanical Engineering

Brea, California

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Today

Job Description: We are seeking a Product Development Tech for our Brea, CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their contacts are primarily with immediate supervisor, project leaders, and other professionals in the unit. Responsibilities: Gathers, maintains, formats, compiles, and manipulates technical data, such as laboratory or material test results and engineering design change

Full-time

Test/NPI Engineer

Irvine, California

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Today

Job Description: The ideal candidate will be responsible for designing, developing, implementing, and supporting test solutions for manufacturing and operational processes. This includes automated test systems, diagnostics, calibration and verification tools to ensure the quality and reliability of products during production. Responsibilities: Design and develop production test systems (hardware and software) for product verification and validation. Collaborate with design, quality, manufacturi

Full-time

Sterilization Engineer II

Remote or New Jersey

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Today

Summary: The Sterilization Engineer is responsible for intermediate activities related to Development Services product and process development, fabrication, and sterilization of materials as work order needs dictate. The ideal candidate should have 7+ years of relevant experience in sterilization engineering within pharmaceutical or medical device environments. Roles & Responsibilities: Turnover, controls, care, and custody from EPCM to client. Signature authority on equipment turnover. Fo

Full-time

Mechanical Engineer

Remote or New Jersey

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Today

Job Description: The successful candidate will be responsible for the design modification packages for mechanical systems and/or components for nuclear power plants. Requirements: Must have commercial nuclear and design modification package experience. Prefers candidates who have lead and driven the modification process. Bachelor of Science degree in Mechanical Engineering from ABET accredited school. 7-10+ years relevant work experience is considered necessary. Working knowledge of codes,

Full-time

Validation Engineer

Irvine, California

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Today

Job Summary: The Validation Engineer will work under limited supervision to support product validation and engineering activities in a regulated medical device environment. The role focuses on leading Continuous Improvement (CIP) initiatives, supporting process validation, and ensuring compliance with applicable regulatory standards. The engineer will collaborate with internal teams and external suppliers to improve product performance, reduce costs, and ensure robust validation of systems and

Full-time

AI Engineer - Clinical Data Science

Remote or New York

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Today

Job Description: We are looking for an AI Engineer to join our Data Science team, building AI-powered solutions for clinical data processing and analysis within a major pharmaceutical organization. You will design, develop and deploy generative AI systems that automate clinical reporting workflows, extract intelligence from documents, and accelerate data-driven decision making. This is a hands-on engineering role - you'll be writing production code, not just building prototypes. Responsibilities

Full-time

Tech 2, Mechanical Engineering

Brea, California

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Today

Job Description: We are seeking a Product Development Tech for our Brea, CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their contacts are primarily with immediate supervisor, project leaders, and other professionals in the unit. Responsibilities: Gathers, maintains, formats, compiles, and manipulates technical data, such as laboratory or material test results and engineering design change

Full-time

Tech 1, Mechanical Engineering

Brea, California

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Today

Job Description: We are seeking a Product Development Tech for our Brea, CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their contacts are primarily with immediate supervisor, project leaders, and other professionals in the unit. Responsibilities: Gathers, maintains, formats, compiles, and manipulates technical data, such as laboratory or material test results and engineering design change

Full-time

Engineer III

Irvine, California

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Today

Responsibilities: Demonstrate creative 'out of the box' thinking to solve difficult problems and develop new technologies to achieve project goals. Design and execute design of experiments and fixture development to support feasibility, development, and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements. Define, develop, and validate/transfer test methods. Create verification plans, protocols, records, and reports. Support inv

Full-time

New Product Development Engineer

Irvine, California

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Today

Full-time

jobs in Irvine, CA, USA