Computer System Validation

PharmEng Technology is currently seeking a Computer System Validation assist our team for projects in Meriden, Connecticut


Job Description
  • Develop and execute computerized systems validation protocols (IQ/OQ/PQ). Validation Summary report, Data Transfer and Integrity Testing Protocol.
  • Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc.
  • Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control etc.
  • Maintain personal training records. Ensure compliance with relevant regulations (e.g. cGMP/GLP/GAMP/GALP).
  • Complete assigned projects and tasks within agreed deadlines.
  • Assessment of client computer systems in terms of FDA 21CFR Part 11 compliance
  • Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects
  • System Implementation ERP SAP
  • Project Management methodology
 
Job Requirements:
  • Recommended) Bachelor Degree and 3-5 years of validation experience or Masters Degree and 2-5 years of validation experience and biotechnology experience.
  • Experience with SAP: SAP products, SDLC, ERP (Enterprise Resource Planning),
  • Familiarity with applicable US and worldwide regulatory requirements for the biotechnology industry (i.e. GMP and GLP).
  • Experience with Microsoft Word and Excel.
  • Willingness to travel
  • Hold a valid driving license and passport
  • Must be able to legally work in Canada/USA
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