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Computer System Validation Csv Pharmaceutical Jobs in Minnesota

UMR

Home Infusion Pharmacist

Roseville, MN · On-site

$60.75 - $73/hr

... from computer system, verifies whether order/drug is reimbursable/covered * Contact members/patients to validate data, resolve rejected claims, request payment information, establish priority of ...

UMR

Home Infusion Pharmacist

Saint Paul, MN · On-site

$58.75 - $70.50/hr

... from computer system, verifies whether order/drug is reimbursable/covered * Contact members/patients to validate data, resolve rejected claims, request payment information, establish priority of ...

UMR

Home Infusion Pharmacist

North Oaks, MN · On-site

$60.25 - $72.50/hr

... from computer system, verifies whether order/drug is reimbursable/covered * Contact members/patients to validate data, resolve rejected claims, request payment information, establish priority of ...

UMR

Home Infusion Pharmacist

Minneapolis, MN · On-site

$60.75 - $73/hr

... from computer system, verifies whether order/drug is reimbursable/covered * Contact members/patients to validate data, resolve rejected claims, request payment information, establish priority of ...

UMR

Home Infusion Pharmacist

Shoreview, MN · On-site

$60.50 - $72.75/hr

... from computer system, verifies whether order/drug is reimbursable/covered * Contact members/patients to validate data, resolve rejected claims, request payment information, establish priority of ...

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Computer System Validation Csv Pharmaceutical information

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

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

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

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

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

What cities in Minnesota are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities in Minnesota with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in Minnesota as of August 2026, with employment types broken down into 33% Full Time, and 67% Contract. Highlights an 100% In-person job distribution.

Computer Systems Validation Engineer

Three Point Solutions, Inc.

Maple Grove, MN • On-site

Contractor

Re-posted 19 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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