Job Description
Interview Report
We now seek 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 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 hire will be based in Ireland and have flexibility to work majority of time from their home office. Some travel as required, to CDMO/CMO sites to fulfil person in plant responsibilities during critical stages of the development program.
Responsibilities for Inhalation Process Engineer:
Support external manufacturing operations during manufacturing process development, scale-up, and technology transfer.
Support manufacturing equipment from design through to CQV, remotely and at Vendor/CMO sites as required.
Development, review and approval of Validation Plans, QRAES, URS, FAT, SATs, IQ, OQ and PQs etc. for process equipment and device manufacture in line with GMPs, regulatory requirements, and the company standards.
Oversee the development and implementation of appropriate documentation, and process work instructions compliant with cGMP.
Support the identification of CPPs and execution of process characterisation studies.
Support the application of a Risk Management process and definition of robust control strategies to manufacturing processes.
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.
Support technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment and processes.
Identify CAPA actions and manage to closure.
Conduct technical assessments of vendors capabilities, including tracking and trending of drug product and device CQAs.
Maintain knowledge of regulatory requirements, industry trends, and emerging technologies related to pharmaceutical manufacturing.
Requirements for Inhalation Process Engineer:
Bachelors or Masters Degree qualification in Science, Engineering or related field.
Certifications in Project Management, Lean/SS and Data Analysis techniques are desirable.
5+ years related experience in Process Engineering, Manufacturing Engineering or Quality Engineering, with experience in combination products required.
Working knowledge of FDA Guideline to Process Validation, ISPE CQV, GAMP, 21 CFR Parts 11/820/210/211 and ISO 14971 is desired.
Knowledge of the relevant regulations and guidelines for inhalation medical devices and combination products is desirable.
Hands on NPI and Technical Transfer execution experience.
Project Management experienceinteracting with internal cross functional teams and externally with third party service providers / vendors / CDMOs / CMOs required.
Excellent written, verbal and presentation skills in English.
Strong planning, organisational, problem-solving, analytical and decision-making skills.