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Director Computer System Validation Csv Jobs in Illinois

Computer System Validation (CSV) / Validation Consultant - Life Sciences Location: Multiple Location Summary: We are looking for an experienced Computer System Validation (CSV) Consultant with strong ...

New

Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... history may have a direct, adverse and negative relationship on the following job duties ...

Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and ... history may have a direct, adverse and negative relationship on the following job duties ...

... of CSV/CSA experience to support implementation of a new Product Lifecycle Management (PLM) system ... computer system validation activities to ensure a compliant and successful system go-live. Key ...

New

This is a project-based role focused on Computer System Validation, also known as CSV, and Computer Software Assurance, also known as CSA. The contractor will support requirements documentation, PLM ...

IL · On-site

Familiarity with computerized systems validation (CSV), cleaning validation, or utility qualification is an added advantage. I am actively connecting with professionals for current and upcoming ...

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 ...

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 ...

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Director Computer System Validation Csv information

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CSV Validation Consultant

Compsciprep LLC

Chicago, IL • On-site

Other

Posted 2 days ago

New


Job description

Hi,                                      

 
Greetings from CompSciPrep!!!
 
We have an immediate opening for a position with one of our prestigious clients that may interest you.
 
Below is the job description for your reference. Please go through it and let me know your thoughts so that we can move forward.
 
Job Description:
 
Role: Computer System Validation (CSV) / Validation Consultant – Life Sciences
Location: Multiple Location 
 
Summary:
We are looking for an experienced Computer System Validation (CSV) Consultant with strong experience in Life Sciences/Pharmaceutical domain. The ideal candidate should have hands-on expertise in validating GxP regulated systems, ensuring regulatory compliance, and supporting clinical and quality applications.
 
Must Have Skills
  • 8+ years of experience in Computer System Validation (CSV)
  • Strong understanding of GxP, 21 CFR Part 11, GAMP 5, FDA regulations
  • Experience in IT Compliance and validation lifecycle
  • Validation of IT Systems and regulated applications
  • Hands-on experience with Veeva Quality Docs
  • Experience with JIRA and HP ALM
  • Validation of Safety Systems
  • Experience with Argus Safety
  • Experience with Veeva Vault
  • Experience working on Clinical Trial Systems
  • Knowledge of CTMS (Clinical Trial Management System)
  • Preparation and review of validation documents (URS, IQ, OQ, PQ, RTM, Validation Plan, Validation Summary Report)
  • Strong communication and stakeholder management skills
Preferred Skills
  • ISO 13485 / Quality Management exposure
  • Clinical, Quality, and Pharmacovigilance system validation
  • Experience working with global pharmaceutical clients
  • Knowledge of SDLC and Agile methodology
Responsibilities
  • Execute end-to-end Computer System Validation activities.
  • Prepare and review validation documentation.
  • Ensure systems comply with GxP and regulatory requirements.
  • Coordinate with business, QA, IT, and vendors during validation.
  • Support audits and compliance activities.
  • Validate clinical, quality, and safety applications.