jobs in irvine, ca, us

Remote or 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

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

Test/NPI Engineer

Irvine, California

•

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

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

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

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

Full-time

Tech 3, Mechanical Engineering

Brea, California

•

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

Tech 2, Mechanical Engineering

Brea, California

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Today

Full-time

Mechanical Engineer

Remote or Phoenix, Arizona

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Today

Job Description: The Mechanical Engineer position is responsible for quality inspection and assurance across various commodities, including precision machined parts, stamping, cast machined, and electromechanical components. The role involves overseeing inspections at multiple stages such as raw material, machining, heat treatment, coating, and final inspection. The engineer will collaborate with various departments, including QA and product engineering, to ensure adherence to specifications an

Full-time

Process Development Engineer

Remote or Worcester, Massachusetts

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Today

Job Summary: We are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design changes, and technology transfer within a regulated medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for manufacturability, assembly, scalability, and operational

Full-time

Process Engineer

Remote or Phoenix, Arizona

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Today

Job Description: Support the deployment of the MTO aspiration "to innovate to safely supply quality products and services competitively, faster, always". Responsible for providing advanced engineering design and start-up of GMP large molecule biologics manufacturing facility systems, and equipment. Provide integrated equipment, utility, and facility engineering expertise with an operational focus in support of technology transfer and manufacturing projects to support 'right first time' executio

Full-time

Product Quality Engineer

Remote or Greenville, South Carolina

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Today

Job Description: We are seeking a Product Quality Engineer to ensure product quality throughout the entire product lifecycle, from design and development through manufacturing and post-market support. The ideal candidate will collaborate with cross-functional teams to establish quality requirements, drive continuous improvement, investigate product quality issues, and ensure compliance with industry and regulatory standards. This role is ideal for candidates with experience in medical devices,

Full-time

Validation Engineer

Remote or Springfield, Massachusetts

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Today

Job Description: Client is looking for onsite Validation Engineers / CQV Engineers to support upcoming qualification work tied to sterile manufacturing and fill/finish operations. The consultants will support hands-on OQ/PQ execution, GMP documentation, protocol execution, discrepancy/deviation support, and equipment qualification activities. The ideal candidate will have direct validation engineering or CQV experience in a fast-paced GMP environment, with strong exposure to fill line qualificat

Full-time

Commissioning & Qualification Engineer

Remote or Cincinnati, Ohio

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Today

Job Description: We are looking for an experienced Commissioning & Qualification (C&Q) Engineer to join our team in support of a major capital expansion project involving the installation of four new packaging lines. This is a hands-on C&Q role embedded within a pharmaceutical secondary and tertiary packaging operation for final drug product. This is not a validation role, we are looking for a true C&Q professional with deep expertise in equipment commissioning, system turnover, and manufacturin

Full-time

Lead Validation Engineer

Remote or New Jersey

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Today

Job Description: The Lead Validation Engineer leads GMP equipment installation, commissioning, and qualification projects supporting large-molecule biologics manufacturing. This role supports upstream and downstream processes and ensures projects are executed safely, on schedule, and in compliance with regulatory and quality requirements. Responsibilities: Lead end-to-end CQV execution for GMP equipment projects, managing activities from installation through IQ, OQ, and PQ for biologics manufact

Full-time

Senior Validation Engineer Consultant

Remote or Massachusetts

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Today

Job Description: Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible for executing IQ/OQ protocols, equipment verification, temperature mapping, SIP/CIP validation activities, deviation support, and ensuring compliance with GMP/GDP standards while collaborating with Engineering, QA, and Operations teams. Roles & Responsibilities: Execute Installation Q

Full-time

Process Validation Engineer

Remote or Indianapolis, Indiana

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Today

Job Description: We are seeking a Process Validation Engineer to support validation and qualification activities in a GMP-regulated manufacturing environment. The ideal candidate will have experience with process validation, equipment qualification, CSV, temperature mapping, and regulatory compliance. Responsibilities: Execute process validation and equipment qualification activities (IQ, OQ, PQ, PPQ). Develop, review, and maintain validation protocols and reports. Support Computer Systems Vali

Full-time

Process Engineer

Remote or Wilson, North Carolina

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Today

Full-time

Process Engineer

Remote or Raynham, Massachusetts

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Today

Roles & Responsibilities Write and execute validation protocols and reports (IQ, OQ, PQ). Develop and implement manufacturing processes, specifications, operator instructions, process studies, and production readiness activities. Conduct investigations, root cause analysis, problem solving, and prepare reports/presentations. Update procedures, manufacturing specifications, bills, routes, and travelers for product/process changes in PLM systems. Work with equipment manufacturers and distributors

Full-time

CQV Engineer

Remote or Raritan, 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 manufa

Full-time

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jobs in Irvine, CA, USA