With global demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support a €500 million expansion project in Leinster.
This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.
This job will be part of a team that is responsible for the technical transfer of key products into the facility.
Essential Duties and Responsibilities for this Process Engineer role include, but are not limited to, the following:
- Execute process engineering activities to support the technical transfer of products to site. This includes but is not limited to: engineering studies, equipment tuning, development batches, single use component fit checks, process simulations, PPQ’s, etc.
- Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams to ensure that the process and product requirements are met.
- Provide technical and product guidance to the process, design and project delivery teams.
- Author and review procedures and technical reports as required as part of the technical transfer.
- Review and approve Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
- Execute activities as part of the Change Management process for the product introduction.
- Represent the site in internal collaborations with Technical Transfer and Commercialization teams to include sharing of best practices.
Requirements as a Process Engineer:
- Process or technical transfer experience in pharma.
- Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines
- Experience with sterile processing and sterilisation technologies
- Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
If you are interested initially, please apply now for immediate consideration and further information.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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