Position Summary
This position is 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-for a Fill/Finish Building at the Clients site.
The Design Engineer will provide technical input to a team of internal engineers and discipline leads from the A&E as well as the suppliers of the process equipment. They provide reviews of all equipment design provided by the suppliers to deliver the design specs and detailed design reports as part of the clients integrated project delivery approach. The project scope includes the design and construction of a new Fill Finish production building.
The position is a hybrid position with an on-site (3 Days) and remote working element. As design progresses, attendance at A&E offices will also be required, and these will count as on-site days.
Due to the nature of the role, the Formulation & Component Prep Engineer will also be required to support FAT's at vendor sites at times during the project.
Principal Responsibilities
* Lead and support client-side design team for formulation and component prep systems within the clients 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 and the clients Engineering Technical Authority (ETA).
* To participate in cross functional package, area, or overall design teams as required in support of the clients 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, 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 required
* To provide input into the calibration programs for formulation & component prep systems, coordinating with the clients site Metrology Group
* To 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 clients project.
Qualifications
* 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.
Education
* Degree level qualification in Chemical / Mechanical Engineering, or similar/equivalent.
