Principal Engineer

Company:
My client is a Pharma and Medical Device company developing combination products with a global portfolio that includes best-in-class, iconic brand-name products, 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 a Subject Matter Expert (SME) in the management and delivery of equipment, including specification, procurement, delivery, qualification, and project management. The successful candidate will lead equipment delivery projects with suppliers, manage budgets, and oversee specifications through to qualification, collaborating with cross-organizational teams. This global role is key to the success of GDD’s varied product portfolio delivery and will provide exposure to all aspects of combination device design, development, and production.

Day to day:

• Develop engineering systems strategy for program delivery, including pilot to scale up, subassembly, final assembly, labelling, packaging, transport, and auxiliary systems. Establish and maintain timelines against organizational requirements and identify external partners/OEMs to meet internal needs.
• Lead engineering systems in cross-departmental teams, managing objectives in line with program delivery. Support the device program team through communication, plan management, technical review, execution, budgetary management, and risk assessment.
• Accountable for process specification, development, and realization from product concept to commercialization, liaising with appropriate internal teams to establish process steps and controls, using good engineering practices. Identify and manage risks through established practices, RAID for engineering systems and program delivery.
• Lead development of bespoke manufacturing processes, specifications, equipment, and systems (manual or benchtop, semi and fully automated) that meet product performance and quality requirements, with a continuous focus on capacity scale-up while managing cost requirements.
• Responsible for site integration; establish training needs, transport, site specifications, commissioning and qualification activities, product quality, and ensuring process performance metrics, development batch records, and product.

Experience required:

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

Does this sound like your next career move? For more info, forward your application or contact me at 087 0612325 or thomas.gallagher@lifescience.ie.