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Computer System Validation Csv Pharmaceutical Jobs in Minnesota

Tech3pillars Technologies

MES Consultant

Virginia, MN · On-site

... pharmaceutical or biotechnology environments. * Basic understanding of GxP regulations, GAMP guidelines, and Computer System Validation (CSV). Technical Skills: * Exposure to MES platforms such as ...

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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. * 3+ years of experience in Verification & Validation, Systems Engineering, Software Quality, or ...

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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.

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

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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.

MES Consultant

Virginia, MN • On-site

Tech3pillars Technologies
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Job description

The person needs to have the system experience, especially around the integration between systems and also good total MES experience. Need more from the System rather than the process side.

Candidate has to be onsite in Norwood/ Boston.

We need a Tempo/ Syncade MES Engineer at Norwood, MA (Onsite only). Attached is the detailed JD, however following are key requirement for the position:

Experience:
  • 2-4 years of experience with MES systems, preferably some in Drug Product manufacturing in pharmaceutical or biotechnology environments.
  • 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.
  • Familiarity with basic programming concepts or languages like SQL, Python, or C#.
  • General knowledge of manufacturing processes, automation systems, and systems integration principles.
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