Senior Process Engineer

Senior Process Engineer required for a 12 month contract based in South Dublin.

We are currently recruiting for a South Dublin based Biopharmaceutical company. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Position Summary:
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.

Key Responsibilities:

• Support the client side design team in its efforts associated with the Fill/Finish Facility
• Lead the client side design reviews in the area of P&ID’s, AF&ID’s, HAZOP’s, GMP Reviews etc.
• 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
• Participate in design reviews, model reviews, etc., and to input on technical elements of the design
• Expedite, coordinate and compile Amgen comments at reviews and to follow up closure during the deign process
• Execute P&ID, URS, Specification and other reviews associated with the Fil/Finish project as requested by the Design manager
• Provide input and assistance to both Automation and CQV in relation to the overall design
• Participate in the design reviews and specifications review of any Vendor Package Equipment as requested
• Provide assistance in the execution 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 of executing project with both a utilities (plant utilities and clean utilities) and HVAC.
• Experience of 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.