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.
- 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