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Computer System Validation Csv Pharmaceutical Jobs in Wisconsin

Inteldot

WI · On-site

$110 - $140/hr

... pharmaceutical or biotechnology industry and hands-on experience with Emerson DeltaV automation ... Lead Computer System Validation (CSV) activities for GMP computerized systems. * Develop, review ...

Lonza

WI · On-site

$80 - $120/hr

As the Computer System Validation (CSV) Expert you will report directly to the local CSV manager and be the domain expert responsible for implementing Computer System Validations at our site in ...

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Eliquent Life Sciences, Inc

CSV Engineer

Mount Horeb, WI · On-site

$120K - $135K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... within pharmaceutical, biotechnology, or life sciences industries. * Working knowledge of: * FDA ... Computer system validation methodologies * Strong technical writing skills with attention to detail.

Deloitte

System Test and Validation Lead

Milwaukee, WI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Milwaukee, WI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Milwaukee, WI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Perrigouk

Associate Validation Scientist

Eau Claire, WI · On-site

$85 - $130/hr

Oversee all Computer System Validation protocol approvals and executions. Scope of the Role ... Experience with validation responsibilities in food, pharmaceutical, or medical device field

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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 Wisconsin?

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

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

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

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

Cities in Wisconsin 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 Wisconsin as of August 2026, with employment types broken down into 33% Full Time, and 67% Contract. Highlights an 100% In-person job distribution.

Senior Computer System Validation (CSV) Engineer - Consultant

Inteldot

WI • On-site

$110 - $140/hr

Other

Posted 10 days ago

Job description

Position Summary

We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems at client. The ideal candidate will have extensive experience validating computerized systems within the pharmaceutical or biotechnology industry and hands-on experience with Emerson DeltaV automation systems. The successful candidate will work closely with Engineering, Automation, Manufacturing, Quality Assurance, and IT teams to ensure computerized systems are validated and maintained in compliance with FDA regulations, GAMP 5, and 21 CFR Part 11 requirements.

Location: Texas (Onsite)

Administrative shiftResponsibilities
  • Lead Computer System Validation (CSV) activities for GMP computerized systems.
  • Develop, review, and execute validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
  • Validate automation systems, including Emerson DeltaV DCS, SCADA, and supporting infrastructure.
  • Support commissioning and qualification activities for new and existing manufacturing systems.
  • Perform impact assessments, change control evaluations, and periodic reviews.
  • Ensure compliance with FDA, cGMP, GAMP 5, ALCOA+, and 21 CFR Part 11 requirements.
  • Collaborate with Automation, Engineering, IT, Manufacturing, and Quality teams during project execution.
  • Support audits and regulatory inspections by providing validation documentation and technical expertise.
  • Review system lifecycle documentation and maintain validated system status.
Required Qualifications
  • Bachelor’s degree in engineering, Computer Science, Information Systems, or related technical discipline.
  • 5+ years of Computer System Validation experience in the pharmaceutical, biotechnology, or medical device industry.
  • Hands-on experience validating Emerson DeltaV systems is required.
  • Strong understanding of GAMP 5, FDA regulations, cGMP, and 21 CFR Part 11.
  • Experience developing and executing IQ, OQ, and PQ protocols.
  • Experience with change control, deviation investigations, CAPA, and risk assessments.
  • Excellent technical writing and documentation skills.
  • Strong communication and cross-functional collaboration skills.
Preferred Qualifications
  • Experience with Manufacturing Execution Systems (MES), SCADA, PLCs, or process automation systems.
  • Knowledge of electronic batch records (EBR) and manufacturing systems integration.
  • Experience supporting commissioning, qualification, and validation (CQV) projects in biologics or sterile manufacturing environments.
Technical Skills
  • Emerson DeltaV (Required)
  • Computer System Validation (CSV)
  • GAMP 5
  • 21 CFR Part 11
  • cGMP/FDA Compliance
  • IQ/OQ/PQ Protocols
  • Risk Assessments
  • Change Control
  • CAPA
  • Commissioning & Qualification (CQV)
  • Automation Systems Validation
  • Technical Documentation
Preferred Industry Experience
  • Biotechnology
  • Pharmaceutical Manufacturing
  • GMP-Regulated Facilities
  • Cell & Gene Therapy or Biologics Manufacturing (preferred)
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