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Computer Systems Validation Engineer Jobs

Software Quality Assurance Computer Systems Validation Specialist - Remote
By W. L. Gore & Associates At , Elkton
Experience with ALM software, IT Service Management (ITSM) e.g. ServiceNow, and Agile Project Management tools e.g. Atlassian Jira
Author, review and/or approve system change, configuration management, and supporting documentation activities
Ensure that test cases are documented and executed following the requirements set forth by procedures and external requirements
Support and monitor the qualification of Information Technology Infrastructure Platforms
Minimum 5 years of experience in a computer system validation role in the medical device, pharmaceutical, biotech, or other regulated industry
Demonstrated experience in software validation documentation and validation principles, including IQ, OQ, and PQ, for both custom and off-the-shelf software/firmware systems
Computer System Validation Engineer/ Csv
By Tech Aveev LLC At Nashville, TN, United States
variety of personalities, discipline skills and educational levels.
•Manage URS and FS, updating customer comments / review cycles.
•Must have a minimum of 4 years in the medical device industry/GMP experience.
. •Experience with Automation equipment for device assembly and testing.
•Knowledge of GAMP (Good Automated Manufacturing Practices) GMP and GDP.
• Demonstrate Excellent interpersonal skills with an ability to interact well with a
Computer Systems Engineer Jobs
By App Maisters Inc. At United States
Strong knowledge and extensive experience with Agile and DevSecOps processes.
Bachelor’s degree with 8-12 years; or a Master’s Degree with 6-10 years of experience.
Years of experience may be used in lieu of degree.
Knowledge of Agile and DevSecOps processes
Posses a DoD 8570.01-M IAT-II certification
Possession of a DoD 8570.01-M IASAE-II certification.
Computer System Validation Consultant
By Vakula Technologies Inc At New Jersey, United States
Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
Background and experience in AGILE SAFE methodology.
Experience in the Pharmaceutical, biotechnology, or medical device industry
3 to 7 years experience in Computer System Validation
Experience in FDA and/or Global regulated environment with a good understanding of GxP standards and Risk-based validation.
Knowledge of FDA guidance and industry standards (i.e., GAMP)
Computer Systems Engineer/Architect
By ManTech At Washington, DC, United States
Bachelor’s degree in computer science or management Information Systems or equivalent discipline
Manage high-volume (more than 1M messages per day) SMTP relays.
Manage the Proofpoint mail security system.
Monitor and manage mail routing using an LDAP directory.
Monitor and manage Infoblox DNS system as well as general BIND/DNS functionality.
Manage IP Address allocations with IPAM
Computer Systems Specialist Jobs
By Mt. San Jacinto College At Temecula, CA, United States
The incumbent should possess knowledge of:
The Incumbent Should Possess Skills In
Lead the order, structure, administration of computer systems
Responsible for assigning, designing and implementing computer systems solutions and related projects
Troubleshoot hardware, software and other problems ranging from simple to complex
Install and maintain hardware, software and client images
Computer Systems Engineer Jobs
By KeenLogic At Atlanta, GA, United States
Strong organization and communications skills; must clearly communicate technical issues and resolutions to team, customers, and management.
Monitor and troubleshoot solutions, including user experience, performance, and availability.
Implement and manage security policies for solutions, including access controls, network security, and data protection.
Collaborate with cross-functional teams to understand business requirements and translate them into technical solutions.
Bachelor's degree preferred or equivalent experience.
4+ years' experience as a Dynamics 365 Service Administrator deploying multiple instances, Dynamics Portal Add-in, Resource mentoring, and service health.
Systems Validation & Verification Engineer
By Siemens Energy At Houston, TX, United States
Experience with design, integration, and management of complex systems over their life cycles
Experience in Project Management / Team Leadership is a plus
Manage the flow-down of top-level product requirements to sub-systems
Manage and maintain verification vs. requirements and raise risks vs. verification strategy
Experience with coordinating activities between engineering disciplines to manage risks and assuring that instrumentation and testing is aligned with verification strategy
Manage and maintain R&D risk registers, organize risk reviews, escalate risks, manage risk closure/treatment/mitigation with risk owners
Computer System Validation Supervisor
By Catalent At , Bloomington, 47403, In
You will assist in the oversight of qualification activities for all capital expansion projects.
You will assist with audits for validation/qualification documentation.
Years of leadership experience, 3+ years preferred
Year of GMP experience, 3+ years preferred
Competitive medical benefits and 401K
Catalent offers rewarding opportunities to further your career!
Computer Systems Engineer Jobs
By Vertogic At , Fremont, Ca

Travel and/or relocate to multiple unanticipated client locations throughout USA.

Jr Systems Linux Engineer- Computer Engineer
By Leidos At , Bethesda, 20889, Md $53,300 - $110,700 a year

Bachelor’s Degree in Computer Engineering, Computer Science, Electrical Engineering, or a related discipline

Position requires US citizenship and ability to obtain DoD interim clearance prior to starting.

Head Of Quality Systems & Validation
By Takeda Pharmaceutical At , Lexington, Ma
Experience with Track Wise Deviation/CAPA, Change Control Management (CCM), SAP and DMAIC philosophy.
Drive digital innovation within Quality Management Systems
Conduct gap analyses and implement Quality Management System procedures
Oversight of all business monitoring type activities, including Quality Council, Management Review, Annual Product Quality Review (APQR) and associated processes.
Establish sustainable business processes are in place for all Quality Management Systems.
Follow domestic and international GMP regulations, cGMP’s, company policies, Takeda leadership behaviors, and conducting performance management
Manager, Computer Systems Validation (Csv)
By Corcept Therapeutics At Menlo Park, CA, United States
Skills, Qualifications, Or Technical Proficiencies
Experienced in developing validation strategies and authoring validation documents such as validation master plans, data migration plans, protocols, reports, discrepancies
Responsible to manage external CSV consultants in CSV projects
Thorough understanding of validation/qualification and concepts as it applies to pharmaceuticals quality systems
Must have excellent communication skills (both oral and written including the ability to effectively communicate across organizational levels and functions
Experience with CTMS and Regulatory systems
Systems Validation & Verification Engineer
By Siemens Energy At , Redmond, 98052, Wa
Experience with design, integration, and management of complex systems over their life cycles
Experience in Project Management / Team Leadership is a plus
Manage the flow-down of top-level product requirements to sub-systems
Manage and maintain verification vs. requirements and raise risks vs. verification strategy
Experience with coordinating activities between engineering disciplines to manage risks and assuring that instrumentation and testing is aligned with verification strategy
Manage and maintain R&D risk registers, organize risk reviews, escalate risks, manage risk closure/treatment/mitigation with risk owners
Computer Systems Engineer Jobs
By AMAX At Fremont, CA, United States
Work to continuously improve AMAX’s products and processes by actively participating with QA, Product Management and Production.
Analyze information to determine hardware change and/or issues based on our customer’s requirements and configurations.
Related experiences in the server industry is highly preferred.
Basic knowledge of latest x86 server architectures including compute, storage, and network.
Linux skill and scripting languages and command-line tools is preferred.
Troubleshoot and test servers based on the most current x86 architecture; main focus is working with the Fremont manufacturing site.
Computer Systems Analyst Jobs
By JSL Technologies Incorporated At , Oxnard, 93030, Ca
1-3 years of demonstrated experience supporting JIRA and/or WIKI systems used in project and program management.
Coordinate with customers and teams to identify requirements and ensure work tracks towards successful completion.
Basic knowledge and training in various IT tools such as JIRA/WIKI, JavaScript, HTML & CSS.
1-3 years of demonstrated experience in JavaScript, HTML & CSS.
1-3 years of demonstrated experience with the Microsoft Office Suite.
Provide training to team members in the use of these tools.