Ascend PM are hiring a Senior Project Engineer to join our clients team, a multinational biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Initially 12 Month Contract with view to extend. Contact or email CV to clairebrogan@ascendpm.ie to find out more
Overview:
The Clean Utilities Project Engineer will have previous relevant experience of Pretreatment Systems, Clean Steam, WFI and Process Air generation and distribution systems, to provide client side design input at the Basis of Design, Detailed Design, Commissioning, Qualification and handover stages of a design project for a Fill/Finish Building.
The scope of the role also includes design input and support during the project phases for various ancillary areas such as the existing Warehouse, a new -30Deg Coldroom, Laboratory reconfigurations, general site infrastructure and the new Multistorey Carpark. Due to the nature of the role, the Clean Utilities Engineer will also be required to support FAT’s at vendor sites at times during the project.
Key Responsibilities:
- To provide technical expertise working with other project stakeholders, in order to achieve design deliverables
- To track, manage and communicate adherence to discipline project milestones
- To coordinate client side clean utilities (Clean Steam / WFI / CA) design by liaising with Site SME’s and Engineering Technical Authority (ETA).
- To lead the client side design reviews in the area of Clean Utilities
- To participate in cross functional package, area, or overall design teams as required in support of overall design goals and expectations
- To input into the Vendor selection and Technical Assessment in support of the instrumentation framework, and/or procurement agreements.
- To participate in design reviews, model reviews, etc., and to input on technical elements of the design
- To execute Drawing, URS, HDS, SDS, Equipment & Instrument Specifications and other reviews associated with Clean Utility installations.
- To participate in CMSAT’s / Loop checking, including any trouble shooting activities
- To provide input and assistance to Automation, C&Q and Validation in terms of equipment packages as required.
- To participate in the design reviews and specifications review of any Vendor Package Equipment in the Facility.
- Provide attendance / assistance for FAT’s / SAT / C&Q and Validation activities at various locations, site or Vendor, as required
- To provide input into the calibration program for clean utilities. To coordinate with site Metrology Group to ascertain calibration requirements and to ensure the execution of calibrations, both equipment and field instruments, in line with these requirements.
- To liaise with the site Maintenance Group and to ensure that any data gathering required to support the MAXIMO system requirements.
- To provide input / direction into schedule and cost discussions, as required, in order to meet the project objectives as defined by the Design Manager, Project Manager and Steering Committee, or designees.
- A site presence will be required during construction. This will involve oversight / supervision of the Clean Utilities element of the project.
Experience & Qualifications
- Minimum of 10 years of experience in pharmaceutical design / build / commission / start-up with direct responsibility for Engineering Documentation, Project Execution or Facility Design.
- Degree level qualification in Chemical / Mechanical Engineering, or similar/equivalent.
- Direct experience in a similar scale project.
- Ability to challenge, defend and present technical aspects of design and commissioning.