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Computer System Validation Jobs

Quality Assurance (Qa)- Computer System Validation
By Assurea LLC At United States
Work closely with CSV management for validation activities and implementation timelines
Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements
Efficient and skilled in writing documents / formatting / understanding Microsoft office and able to create templates etc.
***Required GCLP computerized systems validation and R&D experience
Provide QA support for CSV deliverables and ensure internal procedures and regulations are met.
Perform gap assessment of current computerized systems procedures and policies to ensure applicable regulations are met.
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
System Validation Engineer Jobs
By Google At Mountain View, CA, United States
5 years of experience with consumer product development and validation.
Experience in bench electrical validation, bring-up, triage, deriving DOEs, and statistical analysis for categorizing and capturing improvement/regression.
Experience building relationships that promote cross-team collaboration between EE, PD, Tech engineering, Silicon, Software, CM/JDM, etc. to facilitate project execution.
Experience with consumer electronic analog digital circuits spanning SOC, PMU, Sensors, Display/Touch, Audio, Camera, RF subsystems, and electrical signal characterization/lab equipment.
Master's degree in Electrical Engineering or Computer Engineering.
Own and drive the System Coexistence ERS through collaboration with cross-functional teams.
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
Senior System Validation Engineer
By INTEL At , Hillsboro
OR - Master of Science degree in Electrical/Computer with 5+ years of relevant experience
OR - PhD in Electrical/Computer with 2+ years of relevant experience
In certain circumstances the work model may change to accommodate business needs.
Computer System Analyst Jobs
By Varmoda Tech At Ashburn, VA, United States
Working knowledge of proposal development and capture management for Federal customers
Work as a part of the pre-sales team to provide technical solutions for customer requirements.
Apply principles of CMMI, ISO 9001:2018, ITIL V4, and CMMC to develop the concept of operations to meet technical requirements.
Recommend tools and technologies to meet customer requirements
Develop features and benefits for the technical solution and represent them in complex technical diagrams
Knowledge of Software Development Lifecycle
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 And Information System Manager
By Sky Solutions At United States
Minimum of 5 years of relevant experience in a supervisory or management capacity, with responsibilities for personnel management and financial oversight.
Oversee the management of subordinates, including handling personnel issues, conducting performance evaluations, and supporting professional development.
Ensure effective financial management, tracking, and fiscal oversight of program funding, working in compliance with contractual obligations.
Maintain a working knowledge of IRS organizations, including their infrastructure, responsibilities, programs, and initiatives, to support effective decision-making and coordination.
Bachelor's degree or higher in a technical, business, or management discipline from an accredited college or university.
Working knowledge of IRS organizations, infrastructure, responsibilities, programs, and initiatives is preferred.
Computer-Aided Design And Geographical Information System Coordinator (529198)
By California State University, Office of the Chancellor At Long Beach, CA, United States
Communicates research findings to RES management, campus staff and various internal departments.
Prepares maps, plats, and property descriptions for project site certifications.
Knowledge of plane geometry and trigonometry.
Land Title and Geographical Information Systems Program Manager,
Prepare maps, plats, and property descriptions for easements, leases, and acquisitions.
Reviews records of surveys, easements, and deeds to update LRDB.
Engine Electrical System Validation Engineer
By Onward Technologies Limited At Mossville, IL, United States
Working with requirements managers to understand changes
Engine experience (test cell, performance, …..)
HIL Bench experience (dSpace HIL is a huge plus)
Diesel and/or dual fuel engine experience
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Strong leadership and mentoring skills necessary to provide support and constructive performance feedback.
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!
It Field Technician (Computer System Specialist)
By Labcorp At , Orlando, Fl
Familiarity with Active Directory (adding/deleting/moving PCs), LogMeIn Central/Rescue, MS Office, Outlook and Teams, WebEx, and general help desk ticketing software capabilities.
Proven multitasking abilities and prioritization in a changing environment.
Other duties when requested by supervisor and manager.
Responsible for ordering, inventory, and return of corporate devices on a regular basis.
Install proprietary software, schedule onsite installations with clients, provide face to face and host online trainings with WebEx as needed.
The main work office is in Orlando near Orlando International Airport, with some Work-from-Home opportunities allowable with work needs.
Computer System Administrator Jobs
By City of Springfield, MO At , Springfield, 65802, Mo $55,702 - $86,694 a year
Education, training, and/or work experience should have included experience with related Operating Systems software;
Equivalent work experience may be substituted for the degree requirement.
At least one year experience;
Graduation from an accredited college or university is desirable with a Bachelor's Degree in Computer Science, Information Systems, or related discipline;
Equal Opportunity Employer/Disability and Vet
Resumes alone will not be accepted as the application,
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
System Validation Engineer, Factory Firmware Team
By Tesla At , Fremont, Ca
Knowledge and experience with automation and build tools is a plus (Jenkins, Docker).
Minimum of 2 years of relevant experience in embedded development or test automation.
BS or MS in Computer Science, Computer Engineering, Electrical Engineering, or equivalent practical experience.
Knowledge of version control (Git) and continuous integration.
Excellent verbal and written communication skills to coordinate with the team.
Previous experience in auto-industry or validating embedded system is a plus.
System Validation Engineer Jobs
By Pentangle Tech Services | P5 Group At Canton, MI, United States
· Experience in the automotive industry (minimum 3 year) desirable
· Proficient in DC-DC converters, Good analog and digital design skills
· Fluent in schematics capture, layout and simulation
· Schematic capture and layout, DFMEA analysis, Worst case analysis, Reliability analysis
• An understanding of Functional Safety (ISO 26262) and how it relates to this product.

Are you looking for an exciting opportunity to use your Computer System Validation skills in a fast-paced environment? We are looking for a motivated individual to join our team and help ensure our systems are compliant with industry regulations. You will have the chance to work with cutting-edge technology and collaborate with a diverse team of professionals. If you are looking for a challenging and rewarding role, this is the job for you!

Overview:

Computer System Validation (CSV) is a process used to ensure that computer systems and software used in regulated industries comply with applicable regulations and standards. It involves validating the system design, testing the system, and documenting the results.

Detailed Job Description:

Computer System Validation professionals are responsible for ensuring that computer systems and software used in regulated industries comply with applicable regulations and standards. This includes validating the system design, testing the system, and documenting the results. They must also ensure that the system meets the requirements of the user, and that it is secure and reliable. They must also be able to troubleshoot any issues that arise.

What is Computer System Validation Job Skills Required?

• Knowledge of computer systems and software
• Knowledge of applicable regulations and standards
• Ability to troubleshoot and solve problems
• Attention to detail
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

What is Computer System Validation Job Qualifications?

• Bachelor’s degree in Computer Science, Information Technology, or a related field
• Experience in computer system validation
• Certification in computer system validation (e.g. GAMP 5)

What is Computer System Validation Job Knowledge?

• Knowledge of computer systems and software
• Knowledge of applicable regulations and standards
• Knowledge of system validation processes
• Knowledge of system security and reliability

What is Computer System Validation Job Experience?

• Experience in computer system validation
• Experience in troubleshooting and problem solving
• Experience in documenting system validation results

What is Computer System Validation Job Responsibilities?

• Validate computer systems and software used in regulated industries
• Test systems to ensure they meet user requirements
• Document system validation results
• Troubleshoot and solve any issues that arise
• Ensure system security and reliability
• Monitor system performance and make necessary adjustments