Reference Code
CK3022

We now wish to recruit a CSV Engineer for a BioPharma client site in Cork.

The Automation CSV Engineer will work with the Project Engineer and be responsible for generation of Life Cycle documents for GMP SCADA/PLC & BMS systems changes/upgrades.  The CSV Engineer will support Change Control activities and dealing with Global IT organisations to complete IT risk assessments and raise IT remedy tickets to implement server / PC changes.    

 

Responsibilities:

  • Generating, reviewing and updating SDLC life cycle documentation (RS, QAP, FDS, RTM, FAT, SAT IOQ, QASR and Administration/Disaster Recovery SOPs)
  • Generating and administrating Automation Change Controls for GMP systems
  • Midas Administration of SDLC documentation
  • Coordination with System Integrators on Vendor supplied SDLC documents
  • Interact with Global IT organisations to complete IT risk assessments, raise IT tickets for server / PC / Firewall changes, etc.
  • Compliance SME – 21CFR11, Data Integrity, Change Control, SDLC

 

Skills and Experience:

  • Qualification in Engineering, Computer Science, or other technical degree
  • Minimum 1 year pharmaceutical site experience
  • Understanding of cGMP's and SDLC CSV
  • Excellent ability and willingness to learn and take ownership of CSV aspects of Projects
  • Experience with MIDAS, SAP and Remedy applications
  • Experience with SCADA & BMS Shop Floor systems consisting of Thin/FAT Clients, application/IO/ SQL database server architecture

Please Note

All CV’s are treated in the strictest confidence.
Recruitment agencies need not apply.

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Do you have what it takes ?

CSV Engineer CK3022 - CK3022

Cork, Ireland

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