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Responsibilities The following is an example of the day to day activities (however like all large capex projects there will be a good deal of variety).
Commissioning and Qualification of hardware and associated software to support Utility/Process equipment.
This includes PLC & SCADA plus interfaces with networks.
Documentation preparation of Commissioning, Qualification and Verification protocols (CQV) for process equipment CSV.
Field execution of Commissioning, Installation & Operational Qualification (IQ/OQ), Verification for process equipment automation, including Clean & black utilities.
Co-ordination/review of Vendor Automation packages to achieve streamlined CSV People management Qualifications We are interested hearing from engineers with Intermediate to senior (7+ years) CSV (full lifecycle) experience.
CSV experience of process equipment
- Filling lines, Freeze Dryers / Lyos, vial washers & tunnels, cappers, autoclaves, parts washers, storage vessels, etc.
Strong knowledge of regulations (GAMP5 and 21 CFR Part 11, Annex 11) and modern CQV CSV practices Experience of working with software/automation validation in a project environment. xyswxtq
A degree level in Engineering, or Science related area Hands on attitude, specifically functional testing of equipment outlined above.
Excellent oral and written communication skills in English A high level of customer orientation/understanding
JBRP1_IJ
Languages
- English
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