Current jobs related to Senior Validation Engineer - Bothell - The Crox Group

  • Senior Specialist, Validation

    3 weeks ago

    Bothell, Washington, United States Bristol-Myers Squibb Full time

    Job SummaryThe Senior Specialist, Validation role at Bristol-Myers Squibb is a critical position that requires a deep understanding of GMP, GDP, GXP, GAMP5 regulations, and data integrity requirements. As a Senior Specialist, you will be responsible for developing and executing validation plans for cGMP critical equipment and systems, ensuring compliance...

  • Senior Specialist, Validation

    3 weeks ago

    Bothell, Washington, United States Bristol-Myers Squibb Full time

    Job SummaryThe Senior Specialist, Validation role at Bristol Myers Squibb is a critical position that requires a deep understanding of GMP, lab/manufacturing equipment, and validation processes. As a Senior Specialist, Validation, you will play a key role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset...

  • Senior Validation Specialist

    3 weeks ago

    Bothell, Washington, United States Bristol-Myers Squibb Full time

    Job SummaryWe are seeking a highly skilled Validation Specialist to join our team at Bristol-Myers Squibb. As a key member of our validation team, you will be responsible for ensuring the quality and integrity of our cell therapy products.Key ResponsibilitiesDevelop and execute validation plans for cGMP critical equipment and systemsEstablish validation...

  • Senior Electrical Engineer

    4 weeks ago

    Bothell, Washington, United States General Dynamics Full time

    Job Title: Senior Electrical EngineerGeneral Dynamics Ordnance and Tactical Systems is seeking a highly skilled Senior Electrical Engineer to join our team in Bothell, WA. As a key member of our engineering team, you will be responsible for designing, developing, and testing electrical equipment, components, and systems.Responsibilities:Design and develop...

  • Senior Firmware Engineer

    3 weeks ago

    Bothell, Washington, United States Andrews Cooper Technology LLC Full time

    Job Title: Senior Firmware EngineerAbout the Role:We are seeking a highly skilled Senior Firmware Engineer to join our team at Andrews Cooper Technology LLC. As a Senior Firmware Engineer, you will be responsible for designing, developing, and testing firmware for our embedded systems.Key Responsibilities:- Design and develop firmware for embedded systems...

  • Senior Systems Engineer

    4 weeks ago

    Bothell, Washington, United States Aleron Full time

    Senior Systems EngineerAcara Solutions, a leading aerospace staffing services firm, is partnering with a national aerospace manufacturing client to find a Senior Systems Engineer for a salaried direct employee position. The salary range is $122K - $145K. This is a 100% onsite position in the Bothell, WA plant.Key ResponsibilitiesDesign and develop aerospace...

  • MES Recipe Engineer and Validation Specialist

    3 weeks ago

    Bothell, Washington, United States Aequor Technologies Full time

    Job Title: MES Recipe Engineer and Validation SpecialistJob Summary: We are seeking a highly skilled MES Recipe Engineer and Validation Specialist to join our team at Aequor Technologies. The successful candidate will be responsible for delivering electronic batch record (EBR) configuration and validation in the Emerson Syncade Manufacturing Execution System...

  • MES Engineer

    4 weeks ago

    Bothell, Washington, United States Sunrise Systems, Inc. Full time

    Job Title: MES Engineer - Recipe Development and Validation SpecialistAt Sunrise Systems, Inc., we are seeking a highly skilled MES Engineer to join our team. As a MES Engineer, you will be responsible for delivering electronic batch record (EBR) configuration and validation in the Emerson Syncade Manufacturing Execution System (MES).Key...

  • Senior Mechanical Engineer

    4 days ago

    Bothell, United States Fujifilm Holdings Corporation Full time

    The Senior Mechanical Engineer will be responsible for planning and executing technical projects consisting of the design, fabrication, modification, and evaluation of components involving both mechanical and electro-mechanical devices culminating in Mechanical Engineer, Mechanical, Engineer, Mechanic, Senior, Manufacturing, Technology, Design

  • Senior Manufacturing Test Engineer

    4 weeks ago

    Bothell, Washington, United States Bausch Health Full time

    Job SummaryWe are seeking a highly skilled Senior Manufacturing Test Engineer to join our team at Bausch Health. As a key member of our manufacturing team, you will be responsible for the development, validation, and maintenance of automated and manual test processes and equipment that support our medical device manufacturing and contract manufacturers.Key...

  • MES Recipe Engineer and Validation Specialist

    3 weeks ago

    Bothell, Washington, United States Omni Inclusive Full time

    The MES Recipe Engineer and Validation Specialist role at Omni Inclusive will deliver electronic batch record (EBR) configuration and validation in the Emerson Syncade Manufacturing Execution System (MES).This role will support new product and process deployments as well as EBR revisions within the MES space in conjunction with several cross-functional...

  • Senior System Engineer

    3 weeks ago

    Bothell, Washington, United States Bausch Health Full time

    Job SummaryThe Senior System Engineer will be responsible for ensuring that Solta products meet functional system requirements. This role will coordinate activities involved in system level specification, testing, and development for medical device products in the aesthetic space. The ideal candidate will be a hands-on self-starter, able to work...

  • Senior Project Engineer

    3 weeks ago

    Bothell, Washington, United States Skanska Full time

    We are seeking a dynamic Senior Project Engineer to join our Project Management Team. This role is responsible for planning and overseeing projects to ensure timely and cost-effective outcomes.The ideal candidate will have 5+ years of industry experience, preferably in heavy civil infrastructure, and a Bachelor of Science in Construction or Engineering. They...

  • Senior Project Engineer

    3 weeks ago

    Bothell, Washington, United States The Structures Company, LLC Full time

    Job Title: Senior Project EngineerJob Summary:The Structures Company, LLC is seeking a Senior Project Engineer to provide leadership and technical expertise to our engineering team. As a Senior Project Engineer, you will be responsible for developing project plans, coordinating projects, and communicating changes and progress to stakeholders.Key...

  • Computer Validation Specialist

    6 months ago

    Bothell, United States Omni Inclusive Full time

    Job Title: Computer Validation Specialist Location: Bothell, WA*ONSITE*Local candidates preferred TOP SKILLS: • 3-5+ years' experience in performing periodic review of computerized systems. • Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred. • Experience with development of CSV documentation (Validation Plans,...

  • Senior Ultrasound Engineer

    4 weeks ago

    Bothell, Washington, United States FUJIFILM Corporation Full time

    Job Title: Senior Ultrasound EngineerWe are seeking a highly skilled Senior Ultrasound Engineer to join our team at FUJIFILM Sonosite. As a key member of our engineering team, you will be responsible for leading the development of signal path algorithms and imaging modes for our ultrasound platforms.Key Responsibilities:Contribute to the definition,...

  • Senior Firmware Engineer

    2 weeks ago

    Bothell, Washington, United States Andrews Cooper Technology LLC Full time

    Job Title: Senior Firmware EngineerJob Description:We are seeking a skilled Senior Firmware Engineer to join our team at Andrews Cooper Technology LLC. As a key member of our engineering team, you will be responsible for designing, developing, and testing firmware for our embedded systems. You will work closely with cross-functional teams to develop and...

  • Senior Mechanical Engineer

    4 weeks ago

    Bothell, Washington, United States FUJIFILM Corporation Full time

    Job Title: Senior Mechanical EngineerOverviewFUJIFILM Sonosite is seeking a highly skilled Senior Mechanical Engineer to join our team in Bothell, WA. As a key member of our engineering team, you will be responsible for designing, developing, and testing high-performance transducers for our ultrasound systems.Key Responsibilities:Design and develop new...

  • Senior Ultrasound Engineer

    4 weeks ago

    Bothell, Washington, United States FUJIFILM Corporation Full time

    Job Title: Senior Ultrasound EngineerAt FUJIFILM Sonosite, we are seeking a highly skilled Senior Ultrasound Engineer to join our team. As a key member of our engineering team, you will be responsible for developing and optimizing ultrasound systems, ensuring they meet the highest standards of quality and performance.Key Responsibilities:Contribute to the...

  • Senior Electrical Engineer

    4 weeks ago

    Bothell, Washington, United States FUJIFILM Corporation Full time

    Job Title: Senior Electrical Engineer/Technical Project ManagerOverviewFUJIFILM Sonosite is seeking a highly skilled Senior Electrical Engineer/Technical Project Manager to lead the design and development of hardware products, primarily within the electrical engineering function. As a critical project leadership position within the Hardware Engineering...

Senior Validation Engineer

2 months ago

Bothell, United States The Crox Group Full time

"Job title: Computer System Validation Engineer

Location: Bothell, WA* Hybrid

Top Skills:

• Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).

• Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)

• Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.

PURPOSE AND SCOPE OF POSITION:

The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant and regulations. This includes coordination of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes to existing systems.

DUTIES AND RESPONSIBILITIES:

• Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.

• Author, review and/or approve applicable CSV documentation

• Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures

• Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations

• Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required)

• Other related duties as assigned

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).

• Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)

• Ability to effectively communicate with both technical and non-technical team members.

• Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication

• Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.

• Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.

• Knowledge of IT service management platforms to support change IT operational events (i.e. ServiceNow).

• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).

• Strong technical and problem-solving skills and the ability to work independently.

• Demonstrated success working in a high-performing, business results-driven environment.

Education and Experience:

• Bachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.

• Must have experience with Computer system validation of MES.

• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.