About Us
We are seeking an Inhalation Process Engineer to support the development of proprietary drug-device combination products, with responsibilities for taking early-stage product through scale-up to commercial manufacture. This work will involve manufacturing equipment selection, process design & development, transfer to Contract Manufacturer Organisation (CMO) and scale-up activities.
The successful candidate will lead collaboration and technical oversight of external development and manufacturing partners, focusing on ensuring that the development of robust manufacturing equipment and processes will deliver safe and effective innovative products to market.
This role will be based in Ireland and have flexibility to work majority of time from their home office. Some travel as required, to CMO sites to fulfill person in plant responsibilities during critical stages of the development program.
Responsibilities:
1. Support external manufacturing operations during manufacturing process development, scale-up, and technology transfer.
2. Support manufacturing equipment from design through to qualification, validation, and ongoing monitoring, remotely and at Vendor/CMO sites as required.
3. Development, review and approval of Validation Plans, Quality Risk Assessments, User Requirements Specifications, Factory Acceptance Tests, Site Acceptance Tests, Installation Qualification, Operational Qualification, Performance Qualification etc. for process equipment and device manufacture in line with Good Manufacturing Practices (GMPs), regulatory requirements, and company standards.
4. Oversee the development and implementation of appropriate documentation, and process work instructions compliant with cGMP.
5. Support the identification of Critical Process Parameters and execution of process characterization studies.
6. Support the application of a Risk Management process and definition of robust control strategies to manufacturing processes.
7. Initiate error proofing, yield improvement and cost-reduction programs to drive effective and efficient process output, whilst maintaining the flexibility required within late-stage product development.
8. Support technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment and processes.
9. Identify Corrective Action Preventative Actions and manage to closure.
10. Conduct technical assessments of vendors capabilities, including tracking and trending of drug product and device Characteristics.
11. Maintain knowledge of regulatory requirements, industry trends, and emerging technologies related to pharmaceutical manufacturing.