12 Month Contract
Reports to: Design Manager, Fill/Finish Project
My client is currently in the process of undertaking a Fill finish project and are looking for a Process /Mechanical Engineer to support the client design team in the execution of this project.
The role will be Dublin based, with remote working requirements initially based on Covid constraints. As the project progresses it is expected that the project team will transition to site.
The role is as a currently envisaged duration of 12 months
A Process / Mechanical Engineer with previous relevant experience is required to provide client side design input at Detailed Design and CQV commencement stages of the design of a Fill/Finish Facility and supporting infrastructure. The Primary area of responsibility shall be design support to the Design Manager in the areas of Utility and HVAC design.
* To support my client side design team in its efforts associated with the Fill/Finish Facility
* To lead the client side design reviews in the area of P&ID's, AF&ID's, HAZOP's, GMP Reviews etc.
* To participate in cross functional package, area, or overall design team reviews as required in support of Amgen's overall design goals and expectations for the project
* To participate in design reviews, model reviews, etc., and to input on technical elements of the design
* To expedite, coordinate and compile client comments at reviews and to follow up closure during the design process
* To execute P&ID, URS, Specification and other reviews associated with the Fil/Finish project as requested by the Design manager
* To provide input and assistance to both Automation and CQV in relation to the overall design
* To participate in the design reviews and specifications review of any Vendor Package Equipment as requested
* To provide assistance in the execution of FAT's / SAT / CQV activities at various locations as required
* Any other duties as required to support the Fill/Finish Project
* Degree level qualification in chemical, and/or mechanical engineering, or equivalent.
* Minimum of 5 years of experience in GMP pharmaceutical design/build/commission/start-up with direct responsibility for Engineering Documentation, Project Execution or Facility Design.
* Experience with design, construction or commissioning of pharmaceutical facilities such as a drug substance, drug product or fill/finished facility.
* Experience in executing projects with both a utilities (plant utilities and clean utilities) and HVAC.
* Experience in Validation /Verification of GMP equipment or processes would be beneficial.
* Demonstrated ability to organize and lead a multifunctional team in support of defined objectives.
* Ability to challenge, defend and present technical aspects of design and commissioning.
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