Excellent opportunity for a Solutions Product Development Engineer/ Scientist based in Larne
Terumo BCT Ltd – located in Larne – manufactures a range of sterile fluids for human and veterinary use. A vacancy currently exists for a Solutions Product Development Engineer / Scientist. The successful candidate will be responsible for phase gate design controlled development of new pharmaceutical solutions and support of existing solution products.
Salary: Dependant upon experience
Duties will include:
- Planning, development and maintenance of all design control documentation required for product release and approval.
- Supports Regulatory Affairs submission packages for a variety of regulatory bodies.
- Takes on product development project responsibilities as assigned by project leaders
- Presents complex technical information/analysis and responds to questions from technical staff member and management regularly and effectively
- Reviews and approves product documentation.
- Contributes to the establishment of business objectives, goals, budgets and costs, as requested.
- Participates in inter-organisational and outside customer contacts as needed
- Must be a strong advocate for the design control process in the face of competing opinions and priorities within the Solutions business area.
- Manage product design history files
- Translate international standards and local regulatory requirements into product requirements.
- Participate and/or lead, risk management activities including planning, identification of hazards, analysis, and mitigation
- Lead project activities through phase gate design control product development.
- Create and execute Engineering Change Requests The above list is not considered to be comprehensive and other tasks may be assigned as business needs dictate.
Applicants must possess:
- A minimum of 3 years’ experience in product development, process engineering, manufacturing or quality control roles
- A degree in Engineering, Scientific or similar discipline.
- Experience of design controls related to developing and verifying/validating products along with the associated manufacturing processes in a regulated industry.
In addition the following would be a distinct advantage:
- Experience gained within a medical device, pharmaceutical or other regulated industry
- Knowledge of FDA/EU requirements
- Knowledge of steam sterilisation
- Polymer or plastics biocompatibility requirements
If you would like to apply for this vacancy, please submit an up-to-date CV by clicking on the APPLY NOW button below before the closing date of 4.00 pm on Wednesday 25th September 2019, and quoting reference: 19/24
Terumo BCT Ltd is an Equal Opportunities Employer and welcomes applications from all sections of the community regardless of their gender, marital or family status, religious belief or political opinion, disability,
race or ethnic origin, nationality, sexual orientation or age.