CSV Engineer

  • Location:
  • ID:
  • Post Date:
  • Contract Type:
  • Dublin, Ireland
  • CSV-CWM-#001
  • 10 Jan 2018

Skills

Minimum of 3 years Computerised Systems Validation experience BSc or MSc in Engineering, Life Sciences, or IT is preferred Previous systems validation experience in a cGMP / FDA regulated environment is essential Previous experience working as part of a large, multi-disciplinary team completing full project life-cycle implementations based on GAMP5 Experience in executing Data Integrity Assessments, Reports and Training desirable

Job description

Capable of integrating into a global projects team with responsibilities for generation, signoff & execution of various project & cGMP related document and protocols including Validation Master Plan, URS, FDS/DS, traceability matrix, test specs, IQ, OQ, Integrated OQ & PQ, relevant summary reports and change controls Delivering Data Integrity Assessments, Reports and Training for clients in Highly Regulated Industries Utilization of a risk based approach to determine the validation requirements Project planning specific to the validation related activities