Current jobs related to Computer System Validation Specialist - Bothell, Washington - Aequor
-
Computer Systems Validation Specialist
3 weeks ago
Bothell, Washington, United States Katalyst Healthcares & Life Sciences Full timeJob DescriptionAt Katalyst Healthcares & Life Sciences, we are seeking a highly skilled Computer Systems Validation Specialist to join our team. As a key member of our IT department, you will be responsible for leading and executing validation activities for GxP electronic systems and applications.Key Responsibilities:Lead routine CSV lifecycle activities,...
-
Computer Systems Validation Analyst
4 weeks ago
Bothell, Washington, United States Omni Inclusive Full timeJob Title:Computer Systems Validation SpecialistJob Summary:The Computer Systems Validation Specialist will lead and execute validation activities for GxP electronic systems, with a focus on Systems MES (Emerson) integrations and recipe functions. This role is an individual contributor with occasional oversight of contract resources on a project basis.Key...
-
Senior Specialist, Validation
3 weeks ago
Bothell, Washington, United States Bristol-Myers Squibb Full timeJob 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 Specialist, Validation
3 weeks ago
Bothell, Washington, United States Bristol-Myers Squibb Full timeJob 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...
-
MES Recipe Engineer and Validation Specialist
3 weeks ago
Bothell, Washington, United States Aequor Technologies Full timeJob 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...
-
Senior Validation Specialist
3 weeks ago
Bothell, Washington, United States Bristol-Myers Squibb Full timeJob 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...
-
MES Engineer
4 weeks ago
Bothell, Washington, United States Sunrise Systems, Inc. Full timeJob 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...
-
MES System Specialist
3 weeks ago
Bothell, Washington, United States Synkriom Full timeJob OverviewAt Synkriom, we are seeking a highly skilled MES System Specialist to join our team. As a key member of our organization, you will be responsible for implementing and maintaining our Emerson Syncade MES System.Key Responsibilities:Develop and execute validation protocols for the MES System.Collaborate with cross-functional teams to ensure...
-
MES Recipe Engineer and Validation Specialist
3 weeks ago
Bothell, Washington, United States Omni Inclusive Full timeThe 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...
-
Manufacturing Execution System Engineer
3 weeks ago
Bothell, Washington, United States Axelon Services Corporation Full timePurpose and Scope: The MES Recipe Engineer and Validation Specialist role 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...
-
Computer Systems Analyst
4 weeks ago
Bothell, Washington, United States Lockheed Martin Corporation Full timeJob DescriptionLockheed Martin Rotary & Mission Systems is seeking a skilled Windows System Administrator to join our team in Bothell, WA.Key ResponsibilitiesInstall, configure, and maintain Windows Server 2019 systemsAdminister user accounts, group policies, and advanced system administration tasksPerform hardware and software installation, de-installation,...
-
IT Support Specialist
3 weeks ago
Bothell, Washington, United States Axelon Services Corporation Full timeJob Title: Benchtop Support SpecialistLocation: Bothell, WAJob Description:We are seeking a highly skilled IT Support Specialist to join our Digital Plant organization. As a Benchtop Support Specialist, you will be responsible for providing IT support for our GxP benchtop systems and instrumentation, as well as site and global applications used within the...
-
Security Systems Specialist
3 weeks ago
Bothell, Washington, United States Puget Sound Energy Full timeJob SummaryPuget Sound Energy is seeking a skilled Security Systems Specialist to join our team. As a key member of our Security, Risk and Compliance team, you will be responsible for maintaining and ensuring the reliability of our physical and electronic security systems.Key ResponsibilitiesPerform routine maintenance and repairs on security systems,...
-
Bothell, Washington, United States CIeNET Technologies Full timeJob SummaryCIeNET Technologies seeks a skilled Quality Assurance Tester to ensure the quality of our automotive infotainment systems.Main ResponsibilitiesReproduce and analyze bugs in automotive infotainment systems on various platforms.Perform full regression testing and feature-specific testing to ensure product functionality and stability.Write detailed...
-
Benchtop Support Specialist
3 weeks ago
Bothell, Washington, United States Integrated Resources Full timeJob Title: Benchtop Support Specialist Job Summary: Integrated Resources is seeking a skilled Benchtop Support Specialist to provide IT support in our Digital Plant organization. The successful candidate will be responsible for supporting, enhancing, and maintaining compliance for the GxP benchtop systems and instrumentation as well as site and global...
-
Electrical Systems Specialist
3 weeks ago
Bothell, Washington, United States Katalyst Healthcares and Life Sciences Full timeElectrical Engineering RoleKatalyst Healthcares and Life Sciences seeks an Electrical Systems Specialist to lead the development of electrical systems for medical devices. The ideal candidate will have expertise in electrical engineering lifecycle, electromechanical development, and project management.Key Responsibilities:Develop test procedures for board...
-
Quality Assurance Specialist
3 weeks ago
Bothell, Washington, United States Omni Inclusive Full timeJob Title: QA Associate Specialist Document ControlAbout the Role:We are seeking a highly skilled Quality Assurance Specialist to support our document control operations at our Bothell site. As a key member of our team, you will be responsible for managing our electronic document system, reviewing and approving document change requests, and troubleshooting...
-
Manufacturing Execution System Engineer
3 weeks ago
Bothell, Washington, United States Axelon Services Corporation Full timePurpose and Scope of PositionThe Axelon Services Corporation is seeking a skilled Manufacturing Execution System Engineer to deliver electronic batch record 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...
-
Electrical Systems Engineer
3 weeks ago
Bothell, Washington, United States General Dynamics - Ordnance and Tactical Systems (WA) Full timeJob Title: Sr Electrical EngineerGeneral Dynamics Ordnance and Tactical Systems (GD-OTS) is seeking a highly motivated and experienced Sr Electrical Engineer to join our team in Bothell, WA.Job Summary:We are looking for a skilled electrical engineer to design, develop, and test electrical equipment, components, circuits, or systems for the generation,...
-
Wireless Alarm System Installation Specialist
3 weeks ago
Bothell, Washington, United States TEKsystems Full timeWe are seeking an experienced Wireless Alarm System Installation Specialist to join our team at TEKsystems. As a specialist in this role, you will be responsible for installing, dismantling, and reconstructing wireless home security systems from ADT in customers' homes or small businesses.Duties and ResponsibilitiesInstalls ADT application and configures...
Computer System Validation Specialist
2 months ago
Aequor is seeking a skilled Computer System Validation Engineer to join our team. As a key member of our engineering team, you will be responsible for leading and executing validation activities for GxP electronic systems and applications.
Key Responsibilities:
- Lead routine CSV lifecycle activities, 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.
- Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required).
Requirements:
- Strong knowledge of MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).
- Familiar with the 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 teamwork, client focus, verbal and written communication.
- Knowledge of industry-standard quality and compliance methodology to ensure our IT systems deliver the intended performance and meet regulatory requirements.
- Knowledge of cGMP, GXP, and GAMP, including 21CFR part 11, and good documentation practices.
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.
Compensation:
The starting hourly compensation for this assignment is a range from *** - ***. While the final, individual compensation will be determined by your employer of record (and not Client), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed.
