Company:
My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.


Role:Principal Device Equipment Engineer
Location:Newenham Court, Northern Cross, Malahide rd, Dublin 17
Benefits:Competitive salary, bonus, pension and full family healthcare


Overview:
The Principal Device Equipment Engineer will be an SME in the management and delivery of equipment, inclusive of specification, procurement, delivery, qualification, and project management of the same.

The successful candidate will lead equipment delivery projects with the suppliers, inclusive of budget management, and ownership for specification through to qualification. The candidate will work in collaboration with cross organisational teams.
This is a Global role that is key to the success of GDD’s varied product portfolio delivery and will provide the successful candidate exposure to all aspects of combination device design, development, and production.





Day to day:

• Develop engineering systems strategy for program delivery. Pilot to scale up, subassembly, final assembly, labelling, packaging, transport, and auxiliary systems. Establishing and maintaining timelines against organization requirements and identify external partners/OEMs to meet internal needs.
• Lead for engineering systems in cross departmental teams. Manage engineering system objectives in line with program delivery. Supporting the device program team through communication, plan management, technical review and execution, budgetary management, risk assessment, etc.
• Accountable for the process specification, development and realization from product concept to commercialization, liaising with appropriate internal teams to establish process steps and appropriate controls, using good engineering practices. Identification and management risk through established practices, RAID for engineering systems and program delivery.
• Lead development of bespoke manufacturing processes, manufacturing specifications, equipment, manual or benchtop systems, semi and fully automated equipment that meet product performance and quality requirements. Continuous focus on capacity scale up, whilst managing cost requirements.
• Responsible for site integration; establish training needs, transport, site specification, commissioning and qualification activities, product quality, ensuring process performance metrics, development batch record, process, and product.

• Degree in Science/Engineering with 7+ years’ experience in pharmaceutical and/or medical device development or similar role.
• Strong project management experience is highly preferred.
• Enthusiastic, conscientious, highly driven and motivated person.
• Good communication skills and commitment to teamwork are essential.
• Writing technical reports and producing high quality documentation within a regulatory controlled GMP environment