Clean Utilities Engineer - (2 years contract - minimum)
Our client is expanding its plant with the addition of a second manufacturing line.
We require an experienced Clean Utilities Engineer / Project Manager who can manage the following aspects of the project in FDA regulated GMP environment:
- Insure on-going compliance of existing utilities and facilities during the expansion project
- Plan and organize tie-in’s with minimal interruptions to existing manufacturing processes.
- Own Change Control and execution process in a regulated environment
- Familiarity with validated control systems, e.g. EMS,UMS, CPSS etc.
- Experience with clean utilities, clean rooms and PW water systems
- Carry out NC investigations and eliminate where possible for the new line.
- Review and update existing PPURS, URS’s, PM’s, Calibration assessments, spare parts etc. and project deliverables for the new line.
- Review and comment on design documents, P&ID’s, specifications, IFC drawings etc.
- Support Audits on Clean Utility Systems
- Provide technical expertise in support of design, construction and commissioning activities across range of Clean Utilities.
- Coordinate with technical cross-functional Facilities team and work across engineering disciplines to deliver reliable and sustainable solutions and processes.
- Relevant engineering degree.
- 7+ experience in a similar role.
- Must possess pharma experience.
For further information please contact Mick on 086-0435195 or forward details in confidence to firstname.lastname@example.org