OQ jobs in Remote

Rensselaer, New York

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Today

Summary: We are seeking a Commissioning Engineer to join one of our largest pharmaceutical clients 5x/week onsite in Rensselaer, NY. This individual will be joining the engineering team within the Engineering and Automation space assisting in the commissioning of their stainless-steel pressure vessels in a new facility. Roles & Responsibilities: They will be responsible for assisting in the full life cycle starting with detail design through commissioning, FAT/SAT, IQ/OQ/PQ and qualifications.

Full-time

CQV Engineer

Boston, Massachusetts

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Today

Responsibilities: Generate, execute, review, finalize, and approve validation/qualification protocols and reports. Manage and update project validation plans for specific projects. ssist and deliver amendments to the qualification(s) to ensure qualification compliance within agreed upon timelines. Utilize computerized asset management system for managing validation/qualification schedules. Generate operational and maintenance SOPs, FATs, URSs, FRSs, validation protocols and reports. Requirements

Full-time

Supplier Quality Engineer

Mounds View, Minnesota

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3d ago

We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualification, PPAP documentation, and process validation. This role is critical in ensuring that suppliers meet Medtronics quality standards and regulatory requirements. Key Responsibilities: Supplier Qualification & Management:Qualify suppliers in accordance with company standar

Easy Apply

Contract, Third Party

45 - 50

Manufacturing Tooling Engineer

Raynham, Massachusetts

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3d ago

Looking for a mechanical/manufacturing engineer Experience with process validation required Experience with GD&T, CMM, gaging required Experience with statistical analysis/Minitab preferred Experience with CAD, NX preferred Experience with Windchill preferred Experience with fixture/gage design is a plus Wax injection tooling/injection molding experience is a plus Foundry experience is a plus Required Qualifications Education: Bachelors degree in mechanical engineering, Manufacturing E

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Third Party, Contract

40 - 45

Computer System Validation (CSV) Engineer

Vacaville, California

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Today

Computer System Validation Location: Vacaville CA (Onsite Role) Duration: - 6 -12 Months+ Job Requirements As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable regulations. Key Responsibilities: Develop, execute, and review validation deliverable

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Contract

Depends on Experience

Manufacturing Validation Engineer with CNC

Warsaw, Indiana

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3d ago

Role: Validate CNC equipment and related processes used to manufacture medical devices.Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment.Aim: Ensure robust, reproducible manufacturing processes and maintain inspection-ready documentation.Key Responsibilities Develop and execute validation activities for CNC machines (e.g., mills, lathes, multi-axis CNCs) and associated tooling/work holding.Create and maintain validation do

Easy Apply

Contract, Third Party

40 - 45

Supplier Quality Engineer with Electrical Background

Napa, California

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Today

5 to 6 years of Medical Device Supplier Quality experience with Electrical background.Candidates with IPC certifications & Expertise in PCBA inspections. Experience in Interacting with US & Overseas supplier Experience in Supplier Evaluation & Onboarding Experience in Supplier audits Experience in FAI, Component qualification for components received from suppliers Experience in Process Validation IQ, OQ, PQ Experience in handling SCAR, RCA, CAPA. Experience in document revision control/release

Easy Apply

Contract, Third Party

42 - 47

Sr. Automation Controls Engineer

Newark, California

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Today

Job Title: Sr. Automation Controls Engineer Project Details: The Sr. Automation Controls Engineer will work closely with the Automation Engineering team to upgrade PC-based systems running operating systems older than Windows 11. This role involves upgrading PCs to Windows 11 IoT LTSC, ensuring all corresponding applications are compatible with the new OS. Applications in scope include older versions of: Rockwell FactoryTalk View ME Edition Cognex Designer Vision-Pro (utilizing deep and edge lea

Full-time

Ingeniero Sr Procesos

Nuevo Laredo, Tamaulipas

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Today

Job Description Objetivo General: Define y establece los procedimientos relacionados al proceso para la fabricacin de productos, cumpliendo con las especificaciones de calidad de la manera ms eficiente de acuerdo con los objetivos de la compaa. Responsable en el desarrollo, ejecucin de proyectos y actividades alineando las estrategias de la compaa, para la mejora y/o control de los procesos, as como de los mtricos relevantes de eficiencia, calidad y costo de la planta a travs de anlisis, metod

Full-time

Validation Engineer

Birmingham, Alabama

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Today

Responsibilities: Develop URS, SIC and SRA for new and existing aseptic facilities and equipment. Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols to ensure that systems are installed correctly and according to specifications. Perform operational qualification (OQ) and performance qualification (PQ) activities to verify that systems operate as intended under all conditions. Ensure all documentation is compliant with regulatory requirements and internal qualit

Full-time

Computer System Validation Analyst

Foster City, California

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Today

Summary : Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems. Author documents related to GxP Systems Draft Requirements and computer systems validation documents using GAMP 5 Execute test protocols for the software validation. Initiate and execute change management for existing qualified systems. Develop change management

Full-time

Sr. CSV Engineer

Oregon City, California

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Today

Summary : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems Create and modify validation documentation including but

Full-time

CSV Engineer

Bothell, Washington

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Today

Summary: Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems Create and modify validation documentation including but

Full-time

Sr. Validation Engineer

Wilson, North Carolina

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Today

Summary: The Senior Validation Engineer will lead and execute commissioning and qualification (C&Q) activities for automation systems at the. This role ensures compliance with GMP regulations and internal quality standards, supporting the successful delivery of validation documentation and execution for new and existing systems. Roles & Responsibilities: Lead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation and process systems. Collaborate with cross-function

Full-time

Validation Engineer

Janesville, Wisconsin

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Today

Validation Engineer Needed for Innovative and Fast Growing Technology Company!! This Jobot Job is hosted by: Bryce Koelsch Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $75,000 - $95,000 per year A bit about us: We are a fast growing and innovative fusion-based technology company that is paving the way for commercialized fusion across multiple applications. We currently employ some of the best and brightest in the space and are looking to

Full-time

USD 75,000.00 - 95,000.00 per year

Lead Validation Engineer

Wilson, North Carolina

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Today

Summary: The Lead Validation Engineer will oversee and drive commissioning and qualification (C&Q) activities for automation and process systems at a regulated manufacturing site. This leadership role is responsible for ensuring validation strategies align with regulatory expectations and project goals, while mentoring a team of validation professionals and coordinating with cross-functional stakeholders. Roles and Responsibilities: Lead the planning, execution, and documentation of C&Q lifecyc

Full-time

CSV Engineer

San Francisco, California

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Today

Summary: We are looking for a skilled CSV Engineer with strong experience in Veeva systems to support validation, compliance, and implementation activities in a regulated life sciences environment. The ideal candidate will have hands-on experience working on Veeva platforms and ensuring systems meet GxP and 21 CFR Part 11 compliance. Roles & Responsibilities : Perform Computer System Validation (CSV) activities for Veeva applications. Develop and execute validation documents: URS, FRS, IQ, OQ,

Full-time

New Product Introduction (NPI) Process Engineer

Santa Clarita, California

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Today

Responsibilities: Manage prototype and pilot builds for new product introduction, including operator training and coordination with production planning. Collaborate cross-functionally with Manufacturing and Quality teams to ensure process adoption and compliance. pply Design for Manufacturability (DFM) principles to tooling, process design, and product integration. Support the R&D team with Design Verification (DV) testing and technical reporting. Plan and execute Process Validations (IQ/OQ/PQ)

Full-time

Validation Engineer

Austin, Texas

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Today

Summary: We are seeking a talented Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and systems. You will be responsible for designing, implementing, and executing validation protocols to ensure that equipment, facilities, and processes meet regulatory requirements and industry standards. Roles & Responsibilities: Design and develop validation protocols for SCADA technology used in t

Full-time

Validation Engineer

Raritan, New Jersey

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Today

Full-time

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OQ jobs in Remote