Process Engineer
We are seeking a professional to join our manufacturing project as a process engineer in Sligo.
* Conducting gap analysis, facility fit studies, and process safety assessments for new products.
* Monitoring and analyzing process data during the production phase.
* Collaborating with teams to develop efficient manufacturing processes for new products.
* Providing technical support for process-related issue resolution.
* Developing specifications for NPI materials and consumables.
* Leading risk assessments and developing related documents.
* Working closely with global science and quality teams to develop future products.
* Assisting with product and process investigations and change plans.
* Training operations personnel on NPI processes.
Key Requirements:
* Third-level degree in engineering, science, or technology required.
Preferred Requirements:
* Masters qualification in a relevant discipline desirable.
* 3+ years of experience in pharmaceutical process engineering, with batch processing, technical transfers, scale up, and cGMP knowledge.
* Experience in new product introductions to Biologic facilities beneficial.
Desirable Skills:
* Previous experience with DP fill finish for Biologics product.
* Knowledge of LYO products.
* Technical transfer project delivery and assessment experience.
* Familiarity with single-use design processes.