Project EngineerOur client, a global biotechnology company based in south Dublin, Ireland are looking for a Formulation and Component Prep Design Engineer with experience in pharmaceutical formulation systems, component preparation, and associated equipment (e.g., Autoclaves, Parts Washers, Filter Integrity Testing, Formulation Process etc.). The role provides client-side design input at all stages-Basis of Design, Detailed Design, Commissioning, Qualification, and handover.Key Responsibilities:Lead and support client-side design team for formulation and component prep systems within the Facility.Provide technical expertise to project stakeholders to achieve design deliverables.Track, manage, and communicate discipline project milestones.Coordinate client-side design for formulation and component prep systems by liaising with Site SMEs.To participate in cross functional package, area, or overall design teams as required in support of overall design goals and expectationsTo 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, SDS, Equipment & Instrument Specifications and other reviews associated with the Formulation & Component Prep installations.To provide input and assistance with Automation, C&Q and Validation in terms of equipment packages as required.Provide attendance / assistance for FAT's / SAT / C&Q and Validation activities at various locations, site or Vendor, as requiredTo provide input into the calibration programs for formulation & component prep systems, coordinating with site Metrology GroupTo liaise with the site Maintenance Group and to ensure that any data gathered 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 Formulation & Component Prep element of the project.Basic Qualifications/Experience:Minimum of 5 years of experience in pharmaceutical design / build / commission / start-up with direct responsibility for Engineering Documentation, Project Execution or Facility Design.Direct experience in pharmaceutical formulation systems.Ability to challenge, defend and present technical aspects of design and commissioning.* Degree level qualification in Chemical / Mechanical Engineering, or similar/equivalent.Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go towww.berkley-If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O'Connell on **