Hovione is an international company with over 55 years' experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
To reinforce our team we are looking to fill the following position at our Cork site:
The Design Engineer will work within the Engineering Department. Reporting to the Engineering Manager, the Design Engineer, in conjunction with the Project Engineer, will be responsible for the conversion of an URS into a technical scope and designing the necessary changes within the plant to meet that scope with cross functional inputs to ensure all HSE, Quality and customer needs are met. The Design Engineer is responsible for designing engineering solutions that meet all relevant HSE and cGMP requirements, are cost effective both in implementation operation. The design complexity will be appropriate to the requirements of the technical scope.
- Development of technical scope from URS.
- Generating high level design for initial costing and basis of safety;
- Detailed design and generation of P&ID’s for all project stages. In conjunction with the project engineer and production representatives, generating a gap analysis of equipment and process routing required to execute design;
- Liaising with the engineering team specifying equipment requirements to execute the design;
- Generation of equipment datasheets for quotation / procurement;
- Generation and maintenance of equipment and line list for projectsIn agreement with the CQV engineer generating documentation matrix for procurement to ensure all relevant documentation is requested on placement of orders;
- Generation of equipment tags prior to equipment order.In conjunction with project engineer provide all relevant data in a timely manner to support HAZOP and FMEA activities, and attend these reviews as process design SME;
- Liaise with Automation department to ensure control strategy for solutions are clearly defined and captured in design;
- Attend project review meetings to report out on progress against schedule;
- Interpret the impact on design change requests against cost and schedule and communicate appropriately;
- Provide technical support to production and other departments when appropriate;
- Liaise with suppliers to identify correct equipment type necessary to implement design;
- Work in a proactive manner to improve safety awareness and metrics;
- Support the preparation of budgets within the area and control expenditure;
- Keep up-to-date on technical innovations, advise on same and implement where appropriate.
- Play part in continuous improvement within engineering department.
- Completion of receipt verification of received process materials and equipment.
- Engineering primary degree;
- A minimum of 5-10 years;
- Designs experience in a cGMP environment with demonstrated ability to support customers and manage Designs;
- Excellent interpersonal and communication skills;
- Experience working in an IMB/FDA regulated environment is essential;
- Good knowledge of GMP requirements and understanding of automation activities;
- Demonstrated experience with design of equipment and processes associated with standard pharmaceutical unit operations, including distillation, filtration and API discharge;
- A proven track record in the achievement of schedule driven design deliverables.
- Full time opportunity;
- Competitive remuneration and benefits package;
- Excellent work environment, with a strong focus on safety first, quality always.