Manpower Singapore

CSV Engineer (Pharma/Tuas/ Contract)

Manpower Singapore| Date Posted: 16-Sep-2020
EA Licence No: 02C3423
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Job Nature:
Permanent
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Job Description



CSV Engineer (Pharma/Tuas/ Contract)



Job Description



The Computer System Validation Engineer is responsible and accountable for the preparation and execution of all validation works related to IT/Automation Systems in the pharmaceutical/ biopharmaceutical industry.



Responsibilities:
  • Manage CSV projects in regulated environment
  • Raise Change Control in TrackWise, develop risk assessment, system impact assessments, validation plans / strategies
  • Support project management activities, identify and pro-actively manage project risks
  • Prepare and Review System Development Life Cycle Documents (URS, CRS, QAP, CDS, SDS, FAT/SAT, commissioning, Retirement Plan, etc.)
  • Prepare and review of Qualification protocols (IQ, OQ and PQ)
  • Coordinate with client and various contractors to execute the approved protocols (FAT/SAT, IO/OQ, PQ)
  • Promote cGMP and regulatory compliance into assigned projects per latest regulatory requirements and industry practices


Requirements:
  • Minimum of 5 years validation experience in a cGMP Pharmaceutical/ Biopharmaceutical manufacturing environment
  • Familiar with regulation/compliance requirements, e.g. FDA, EMA, GxP, GAMP5, 21 CFR Part 11, etc.
  • Knowledge understanding of System Development Life Cycle approach (URS, CRS, QAP, CDS, SDS, FAT/SAT, commissioning, I/O/PQ protocols, Retirement Plan, etc.)
  • Good knowledge and validation experience in Automation Systems (PLC, SCADA, DCS, etc.) will be desirable
  • Excellent written and verbal communication skills
  • Strong organizational and project management skills
  • Must be a self-starter and highly motivated
  • Preferably with Degree in IT, Science or Engineering






If you have the relevant skillsets, please send in your updated CV in word format to [Click Here to Email Your Resume] or click on "APPLY NOW".



We regret only shortlisted candidates would be contacted.





Sherry, Yew Koon Ng EA License No.: 02C3423 Personnel Registration No.: R1657259

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