CW Project Engineer
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.
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 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 FATs at vendor sites at times during the project.
Principal Responsibilities:
* Lead and support client-side design team for equipment associated with the formulation and component prep areas within then new Facility.
* Provide technical coordination across design disciplines (process, mechanical, automation, CQV, and facilities) to achieve design deliverables.
* Participate in and facilitate design and model reviews, ensuring alignment with Amgen standards, project scope, and GMP requirements.
* Coordinate client-side design for by liaising with Site SMEs and Engineering Technical Authority (ETA).
* 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.
* Track and manage engineering deliverables, schedule milestones, and cost input for assigned systems and packages.
* Support vendor selection, FAT/SAT attendance, and resolution of technical issues during equipment fabrication and installation.
* 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 systems, coordinating with ADL 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 project.
Qualifications:
* 5+ years of experience in engineering design, project execution, or commissioning/start-up in the pharmaceutical or advanced manufacturing industry.
* Proven track record in delivering capital projects or major equipment installations from concept to handover.
* Strong understanding of engineering documentation, project lifecycle management, and design coordination.
* Demonstrated ability to lead technical discussions, challenge design decisions constructively, and resolve cross-functional issues.
* Excellent communication and stakeholder management skills in a collaborative, matrixed environment