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Computer System Validation Manager Jobs in Minnesota

EoS Fitness

Assistant Fitness Manager

Houston, MN

Must have a valid Personal Training certification * CPR certification required within 30 days of ... Ability to access and operate the Company computer system including preparing documents, entering ...

EoS Fitness

Fitness Manager

Houston, MN

Must have valid PT certification. * Previous sales experience required. * Ability to work in a gym ... Ability to access and operate the Company computer system including preparing documents, entering ...

EoS Fitness

General Manager

Houston, MN

As General Manager, you will work to improve sales, overall processes, and develop a team of ... Ability to access and operate the Company computer system including preparing documents, entering ...

Actalent

Software Validation Engineer

Minneapolis, MN

$50 - $70/hr

Author NonProduct Software Validation quality records in accordance with regulations, standards ... Experience with systems like PLM (Product Lifecycle Management) and ERP (Engineering Resource ...

Forj Medical

Validation Engineer, Senior

Saint Paul, MN · On-site

$100K - $115K/yr

... system-wide improvements. * Perform rigorous analysis of processes and trends to keep executive management informed of key metrics and to recommend improvements. Technical Execution * Lead validation ...

Danaher

Manager Quality Assurance, Validation

Chaska, MN

$130K - $160K/yr

And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact ... The Quality Assurance Manager , Validations is located in Chaska, MN and reports to the Director of ...

Danaher

Manager Quality Assurance, Validation

Chaska, MN · On-site

$130K - $160K/yr

And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact ... The Quality Assurance Manager , Validations is located in Chaska, MN and reports to the Director of ...

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Computer System Validation Manager information

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

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What cities in Minnesota are hiring for Computer System Validation Manager jobs? Cities in Minnesota with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Minnesota as of July 2026, with employment types broken down into 50% Full Time, and 50% Contract. Highlights an 100% In-person job distribution.
Verification & Validation Engineer

Verification & Validation Engineer

DivIHN Integration Inc

Plymouth, MN • On-site

Contractor

Re-posted 15 days ago

Job description

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.

 
Please apply or call one of us to learn more

For further inquiries regarding the following opportunity, please contact our Talent Specialist:
Nithiya at (224) 507-1292
Vinod at (224) 507-1294
 
Title: Verification & Validation Engineer
Duration: 12 Months
Location: Plymouth, MN
 
Description:

As a member of the Acute Therapies Verification and Validation engineering team, you would be responsible for supporting product verification, validation, and compliance test activities on electrical and mechanical medical device components/systems. Your expertise will be applied to all levels of product development from component prototypes to final system design. This will include developing, executing, and validating test methods/creating associated documentation. Interface with/support different groups, e.g., R&D, Project Management, Quality, and manufacturing.
 
Responsibilities include but not limited to:
• Under supervision, Develop/execute verification test methods, protocols, and reports for verification of requirements on components and systems
• Drive quality into product development through analysis, test, and timely feedback of test results back to team
• Under supervision, Design test cases to include test methodology, test setups, materials, equipment, procedure, and acceptance criteria based on requirement and standard
• Execute functional testing of mechanical assemblies, electrical circuits, and systems
• Support hardware team in product development, concept feasibility, pre compliance and change activities by developing test, collecting, and providing test data
• Under supervision, design hardware and/or software tools and fixtures used to execute test methods and analyze data
• Review, understand and characterize electrical/mechanical designs to develop test methods and ensure coverage of requirements
• Read/understand medical compliance standards and requirements, evaluate risk, and develop test procedures to ensure requirements are met
• Perform hands on test execution in the lab and at third party medical device test labs, communicate all defects/issues/failures during the test execution.
• Under supervision, develop and implement feasibility and characterization testing on designs
• Analyze test data for conformance to pre-determined acceptance criteria and record clearly results in testing platforms like ALM.
• Collaborate with System team to better understand requirements and improve test effectiveness.
• Actively participate in improving existing testing scenarios and test cases.
• Maintain laboratory equipment and inventory levels for laboratory supplies
• Perform troubleshooting, hands on rework and calibration of electromechanical Systems
What you'll bring
• Bachelor's degree in Engineering with 1+ years of experience
• Experience with system and component level electromechanical V&V testing, plans/procedures/reports, equipment, and test methods preferred
• Demonstrated results in both Troubleshooting/resourcefulness; use own expertise/guidance from others to identify/resolve critical issues. Understanding/application of root cause analysis methods.
• Knowledge of electrical/mechanical engineering disciplines with ability to read, understand and analyze electrical schematics/ mechanical drawings
• Experience using electrical/mechanical lab equipment. e.g., oscilloscope, DMM, power supply, force/pressure gauge, caliper, thermometer, flow meter and scales
• Takes a hands-on approach to testing, fault diagnosis and isolation
• Experience creating detailed, clear, and complete documentation and records
• Demonstrated experience collaboratively and effectively across disciplines/project teams
• Comfortable/effective in a fast-paced environment, where small teams share a broad variety of duties

About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.