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Computer System Validation- IT/ERP

Ontario, Ontario
PharmEng Technology is currently seeking a Computer system Validation- IT/ERP assist our team for projects in Ontario, Canada.

Job Description: 
  • Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects
  • Draft templates for High level Risk Assessments, User Requirements Specification, Validation Plan and Validation Summary Reports
  • Prepare validation documentation packages and complete validation of Computerized Laboratory Systems
  • Provide guidance and mentoring to the R&D staff in validation procedures and regulatory requirements
  • Review existing validation documentation 
  • Develop validation remediation strategy

Job Requirements:  
  • Minimum 5 to 7 years' of CSV experience in the Pharmaceutical, Biotechnology or Medical Devices industry or 5 to 10 years' of related experience in I.T. ​experience
  • Bachelors' Degree in I.T. or related field 
  • A strong background in I.T. is preferred
  • Experience with SAP: SAP products, SDLC, ERP (Enterprise Resource Planning),
  • Previous experience with Clearwave system software is preferred
  • Strong Computer Systems Validation skills
  • Solid understanding of Computer Systems Validation of Manufacturing and Packaging systems
  • Working knowledge of regulations (cGMP – FDA 21CFR Part 11, Good Automated Manufacturing * Practice (GAMP4), GLP and Good Automated Laboratory Practice (GALP)) and current industry practices in hardware/software validation and computerized systems such as SAP, LIMS, automated DCS, BMS, Delta V etc.
 
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
 
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