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Computer System Validation Manager Jobs in Minnesota

Tech3pillars Technologies

MES Consultant

Virginia, MN · On-site

Basic understanding of GxP regulations, GAMP guidelines, and Computer System Validation (CSV). Technical Skills: * Exposure to MES platforms such as Tempo, Syncade, or equivalent systems is preferred.

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Pohlad Companies

Advanced V&V Engineer

Shoreview, MN · On-site

$90K - $110K/yr

Bachelor's degree in engineering, Computer Science, Systems Engineering or related technical field ... Strong understanding of requirements management, configuration management, and requirements ...

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Computer System Validation Manager information

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 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 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.

What are popular job titles related to Computer System Validation Manager jobs in Minnesota?

For Computer System Validation Manager jobs in Minnesota, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Manager jobs in Minnesota look for?

The top searched job categories for Computer System Validation Manager jobs in Minnesota are:

Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Minnesota as of September 2026, with employment types broken down into 50% Full Time, and 50% Contract. Highlights an 100% In-person job distribution.

Computer Systems Validation Engineer

Maple Grove, MN • On-site

Three Point Solutions, Inc.
Recruiting and Staffing Services • 11 - 50 employees
Learn more about Three Point Solutions, Inc.external

Contractor

Re-posted 13 days ago

Job description

Job Title: Computer Systems Validation Engineer
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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