Principal Engineer, Device and Product Performance
- BBBH779339 Apr 08, 2021 €70k - €90k
We are currently seeking a Subject Matter Expert who will aid in the delivery of a large product range around the globe.
Our client, based in Dublin, develops device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products. They are looking for an established engineer to support innovative technology solutions and to provide healthcare solutions for their patients. Every member of their team is dedicated to creating better health for a better world, one person at a time.
Key responsibilities for this role include:
- Responsible for providing technical leadership to support device development across the biologic portfolio.
- Development of the device design requirements and specifications and for performing robust device and product characterization throughout the design development program.
- Responsible for technical interface between drug product and device teams during combination product development on elements such as primary container interface and compatibility, exhibit batch manufacture and shelf life studies.
- Provide technical support to manufacturing sites during filling and assembly process development. Responsible for designing experiments and manufacturing trials to identify process controls, reliability requirements, sampling plans and release specifications.
- Responsible for metrology, engineering verification, design verification, device functional stability, defect management, biological evaluation, extractables/ leachable, specifications & method development and transport & shipping studies.
- Trending and statistical analysis of analytical and manufacturing data including compilation of technical reports to support combination product development lifecycle.
- Responsible for critical review of the device analytical and manufacturing control strategy for projects by ensuring regulatory requirements are incorporated into development plans.
- Responsible for compilation and review/approval of technical documentation. in line with global regulatory requirements, guidance and the latest regulatory and industry thinking.
- Ensures all activities within the team are conducted and executed to the appropriate quality standards within the Quality Management system.
The minimum qualifications for this role are:
- The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environment.
- Masters/Degree in Engineering/Science with 5 years' experience in R&D or Technical Support environment
- Previous experience of working as an Engineer or Scientist role in a regulated and GMP environment on injectable devices
- Previous experience in compiling analytical and/or manufacturing control sections of regulatory submissions is desirable
- A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
- Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role
- It is essential that the candidate will be both highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams. In addition, the candidate must be able to work under pressure and have a proven track record of problem solving and effective time management.
- Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders
- Some travel will be required as part of this role
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
353 (0) 21 2300300