SDLC Validation Lead

Overview

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 (GAMP®5 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