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