Computer System Validation Consultant

Proclinical is currently recruiting for a Computer System Validation Consultant with a biotechnology company located in Durham, NC.

Job Description:

• Performing gap analysis and remediation activities for IT manufacturing and/or IT R&D systems
• Generating Validation Plans, generating or remediating URS, FS, DS, CS, Risk Assessments
• Conducting Risk Assessment workshops
• Writing and executing test scripts

Skills and Requirements:

• S. or B.A. preferably in IT, Engineering
• IT enterprise system validation is a must, IT manufacturing system (examples: Oracle, SAP, trackwise, LIMS, Empower, Kneat, EDMS, etc.) and/or IT R&D (Regulatory information systems) systems validation
• Experience working in HPALM is required
• Performing gap analysis and remediation activities for IT manufacturing and/or IT R&D systems
• Generating Validation Plans, generating or remediating URS, FS, DS, CS, Risk Assessments
• Conducting Risk Assessment workshops
• Writing and executing test scripts. Experience working in HPALM is required
• 10-15 years of experience in Computer Systems Validation, IT in a pharma environment
• Please note: This position is strictly for CSVs / IT BAs
  
  
  

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-ZH1

#TechOps