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 fulfill person-in-plant responsibilities during critical stages of the development program.
Responsibilities for Inhalation Process Engineer:
* Support external manufacturing operations during process development, scale-up, and technology transfer.
* Support manufacturing equipment from design through to CQV, remotely and at Vendor/CMO sites as required.
* Develop, review, and approve Validation Plans, QRAEs, URS, FAT, SATs, IQ, OQ, and PQs for process equipment and device manufacture, ensuring compliance with GMPs, regulatory requirements, and company standards.
* Oversee the development and implementation of documentation and process work instructions compliant with cGMP.
* Support identification of CPPs and execution of process characterization studies.
* Support application of risk management processes and define robust control strategies for manufacturing processes.
* Initiate error-proofing, yield improvement, and cost-reduction programs to enhance process efficiency while maintaining flexibility for late-stage development.
* Assist in technical root cause analysis, incident investigations, and troubleshooting related to manufacturing equipment and processes.
* Identify CAPA actions and ensure their closure.
* Conduct technical assessments of vendor 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:
* Bachelor's or Master's Degree in Science, Engineering, or a related field.
* Certifications in Project Management, Lean/SS, and Data Analysis techniques are desirable.
* At least 5 years of experience in Process Engineering, Manufacturing Engineering, or Quality Engineering, with specific experience in combination products.
* Working knowledge of FDA guidelines to Process Validation, ISPE CQV, GAMP, 21 CFR Parts 11/820/210/211, and ISO 14971 is preferred.
* Knowledge of regulations and guidelines for inhalation medical devices and combination products is desirable.
* Hands-on experience with NPI and Technical Transfer execution.
* Project management experience involving internal cross-functional teams and external vendors/CMOs/CDMOs.
* Excellent communication skills in English, both written and verbal, along with strong planning, organizational, problem-solving, analytical, and decision-making skills.
Please note: If you are not a passport holder of the country for this vacancy, you might need a work permit. For more information, check our Blog.
Bank or payment details should not be provided when applying. All applications should be made via the 'Apply now' button.
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