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Clean Utilities Engineer

Reference ID : 401MQ
Category :
  • Pharma / Biotech
Date Posted : Aug 13, 2019
Job Location
:
  • Munster
- Limerick
Experience : 5+ Years similar role
Salary : Negotiable salary/rate DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 086-0435195
Our client is expanding its plant with the addition of a second manufacturing line. Seeking senior engineer to manage clean utilities aspect.

Principal Responsibilities

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.

Qualifications & Requirements

  • 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 jobs@headcount.ie


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