SDLC Validation Lead

Job DescriptionOverview Due to large scale Biotech project wins we now wish to recruit a Senior CSV Engineer(s) to join a highly skilled PM Group team based a client site. 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.

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 TPBN1_IJ