Job Title: Computer Systems Validation Engineer Client: Medical Device Manufacturing Company ... Hands-on experience with SDLC (System Development Life Cycle) . * Excellent organizational, verbal ...
Job Title: Computer Systems Validation Engineer Client: Medical Device Manufacturing Company ... Hands-on experience with SDLC (System Development Life Cycle) . * Excellent organizational, verbal ...
Computer Systems Validation Engineer-12345 About This Role: * To ensure the quality of our client ... Create documents, links and Change Requests utilizing a Product Data Management system. * Provide ...
Computer Systems Validation Engineer-12345 About This Role: * To ensure the quality of our client ... Create documents, links and Change Requests utilizing a Product Data Management system. * Provide ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Validation activities include testing in both vehicle environments and Hardware-in-the-Loop (HIL) simulation systems. The engineer will execute DVP&R test procedures, perform initial root-cause ...
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Software Validation Engineer
Plymouth, MN · On-site
$90K - $100K/yr
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Software Validation Engineer
Plymouth, MN · On-site
$90K - $100K/yr
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Participate in system implementations, enhancements, and integrations as the computer system validation representative. * Review supplier documentation, perform supplier assessments, and evaluate ...
Validation Lead
Brooklyn Park, MN · On-site +1
Lead and manage validation projects. This role coordinates, supports and assists all aspects of a ... Participate in the development of an audit plan for internal computer systems and external vendors ...
Validation Lead
Brooklyn Park, MN · On-site +1
Lead and manage validation projects. This role coordinates, supports and assists all aspects of a ... Participate in the development of an audit plan for internal computer systems and external vendors ...
Quality and Compliance Manager - Regulated Software Systems
Saint Paul, MN · On-site
$107K - $161K/yr
Ensure all software development and deployment activities comply with applicable regulations (e.g., FDA 21 CFR Part 11, GxP, GAMP 5). * Lead the Computer System Validation (CSV) process, including ...
Quality and Compliance Manager - Regulated Software Systems
Saint Paul, MN · On-site
$107K - $161K/yr
Ensure all software development and deployment activities comply with applicable regulations (e.g., FDA 21 CFR Part 11, GxP, GAMP 5). * Lead the Computer System Validation (CSV) process, including ...
Validation Engineer
Moundsview, MN · On-site
$75K - $115K/yr
We are seeking a Validation Engineer to support projects, technical transfers, and ongoing ... and computer systems. * Experience supporting commissioning and qualification of major capital ...
Validation Engineer
Moundsview, MN · On-site
$75K - $115K/yr
We are seeking a Validation Engineer to support projects, technical transfers, and ongoing ... and computer systems. * Experience supporting commissioning and qualification of major capital ...
Validation Engineer
$75K - $115K/yr
We are seeking a Validation Engineer to support projects, technical transfers, and ongoing ... and computer systems. * Experience supporting commissioning and qualification of major capital ...
Validation Engineer
$75K - $115K/yr
We are seeking a Validation Engineer to support projects, technical transfers, and ongoing ... and computer systems. * Experience supporting commissioning and qualification of major capital ...
Computer Systems Engineer Contract Duration: 6 months, possible extension Location: St. Paul, MN ... Linux operating system internals * Experience in Linux shell scripts, Perl and/or python. * Working ...
Computer Systems Engineer Contract Duration: 6 months, possible extension Location: St. Paul, MN ... Linux operating system internals * Experience in Linux shell scripts, Perl and/or python. * Working ...
R&D IT Site Lead
Plymouth, MN · On-site
... computer system validation. Monitor the helpdesk ticketing queue and SLA adherence. Provide in-country support for R&D IT tools and applications to external partners and other locations. Serve as the ...
Quick apply
R&D IT Site Lead
Plymouth, MN · On-site
... computer system validation. Monitor the helpdesk ticketing queue and SLA adherence. Provide in-country support for R&D IT tools and applications to external partners and other locations. Serve as the ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Conduct System Impact Assessments (SIA) and Risk Assessments. * Define CQV deliverables, acceptance ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Conduct System Impact Assessments (SIA) and Risk Assessments. * Define CQV deliverables, acceptance ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Conduct System Impact Assessments (SIA) and Risk Assessments. * Define CQV deliverables, acceptance ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Conduct System Impact Assessments (SIA) and Risk Assessments. * Define CQV deliverables, acceptance ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Conduct System Impact Assessments (SIA) and Risk Assessments. * Define CQV deliverables, acceptance ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Conduct System Impact Assessments (SIA) and Risk Assessments. * Define CQV deliverables, acceptance ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Conduct System Impact Assessments (SIA) and Risk Assessments. * Define CQV deliverables, acceptance ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Conduct System Impact Assessments (SIA) and Risk Assessments. * Define CQV deliverables, acceptance ...
Computer System Validation information
See Minnesota salary details
$10.36 - $17.08
2% of jobs
$17.08 - $23.80
9% of jobs
$23.80 - $30.52
1% of jobs
$30.52 - $37.24
4% of jobs
$41.32 is the 25th percentile. Wages below this are outliers.
$37.24 - $43.96
15% of jobs
$43.96 - $50.68
9% of jobs
The median wage is $56.28 / hr.
$50.68 - $57.40
13% of jobs
$62.75 is the 75th percentile. Wages above this are outliers.
$57.40 - $64.12
29% of jobs
$64.12 - $70.84
12% of jobs
$70.84 - $77.56
2% of jobs
$77.56 - $84.29
5% of jobs
$10
$53
$84
How much do computer system validation jobs pay per hour?
What are some typical challenges faced in Computer System Validation roles?
Professionals in Computer System Validation often encounter challenges such as keeping up with evolving regulatory requirements, ensuring complete and accurate documentation, and coordinating with cross-functional teams to implement validation protocols. Balancing thoroughness with project deadlines can also be demanding, as every validation step must stand up to external audits. However, these challenges provide valuable experience, strengthen project management abilities, and emphasize teamwork—key attributes that support career advancement into validation leadership or quality assurance roles.
What is a Computer System Validation job?
A Computer System Validation (CSV) job involves ensuring that computer systems used in regulated industries, such as pharmaceuticals and medical devices, meet compliance and regulatory requirements. CSV professionals develop and execute validation protocols to confirm that software, hardware, and processes function as intended and maintain data integrity. They work with quality assurance, IT, and regulatory teams to document compliance with standards like FDA 21 CFR Part 11 and GxP. This role is critical in maintaining system reliability, product quality, and patient safety.
What is the salary of computer system validation?
What are the key skills and qualifications needed to thrive in the Computer System Validation position, and why are they important?
To excel in Computer System Validation, candidates typically need a background in computer science, engineering, or life sciences, with expertise in validating software and systems in regulated environments such as pharmaceuticals or medical devices. Familiarity with tools like validation documentation software, GAMP 5 guidelines, FDA 21 CFR Part 11 regulations, and potentially certifications like CSV Professional or Six Sigma is highly valued. Strong attention to detail, analytical thinking, and effective communication skills help professionals work collaboratively and document findings precisely. These abilities ensure compliance, data integrity, and the reliability of computerized systems critical to safety and quality.
What is the work of computer system validation?
Is computer system validation a good field?
Is CSV a skill?
Contractor
Posted 21 days ago
Job description
Client: Medical Device Manufacturing Company
Location: Maple Grove, MN 55311
Duration: 6 Months Contract
Focus Area: FDA-regulated Medical Device Software/Systems Validation
Position Overview
The Computer Systems Validation Engineer will be responsible for validating software and equipment in compliance with FDA regulations and company policies. This role will ensure that systems meet strict quality, compliance, and documentation standards. The ideal candidate will have strong technical expertise in validation processes, SDLC, and regulatory compliance, with experience in medical device manufacturing.
Key Responsibilities
- Define, develop, and maintain comprehensive specifications for equipment/software (e.g., PLCs, Visual Basic apps, databases, SCADA applications, FDA-regulated systems).
- Develop and review validation/qualification protocols, ensuring compliance with FDA requirements and QSR regulations.
- Execute validation and qualification protocols, record results, and manage documentation via Change Requests.
- Provide project estimates independently and review estimates for junior engineers.
- Perform project lead activities on small to large-scale validation/qualification projects.
- Ensure consistency and quality of validation work through peer reviews, mentoring, and training of Engineer I's and II's.
- Support audits and regulatory inspections by providing accurate documentation and validation evidence.
- Drive compliance with 21 CFR Part 11 (electronic records/e-signatures) and other FDA guidelines.
- Influence cross-functional engineering initiatives and contribute to defining departmental best practices.
Required Qualifications
- Bachelor's Degree in an Engineering discipline.
- 5-9 years of direct experience in software/equipment validation within a regulated environment.
- Strong background in medical device manufacturing and compliance documentation.
- Hands-on experience with SDLC (System Development Life Cycle).
- Excellent organizational, verbal, and written communication skills.
- Proficiency in MS Office tools.
- Ability to manage multiple priorities, with high attention to detail.
- Strong interpersonal skills and a collaborative, team-oriented mindset.
Preferred Qualifications
- Prior experience in an FDA-regulated industry.
- Experience supporting audits and working with regulatory bodies.
- Prior quality role experience ensuring compliance with industry standards.
- Practical knowledge of 21 CFR Part 11 (electronic records/electronic signatures).
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About Three Point Solutions
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
11 - 50 Employees
Headquarters location
Nisswa, MN, US
Year founded
2003