Team Horizon is seeking a Project Process Engineer for a Pharmaceutical manufacturing company in Sligo.
You will be based at the fill finish site, involved in filling line processes, investigations/evaluations of new products, monitoring process efficiency and KPIs, tracking trends, conducting gap assessments for new products, and implementing technical documentation and process improvements.
Why you should apply:
* Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
* You enjoy working on exciting projects and want to work with a global manufacturing site in Sligo.
What you will be doing:
* Process Engineer for Fill Finish Manufacturing site.
* Leverage detailed understanding of aseptic fill finish manufacturing for design input into equipment commissioning and qualification.
* Responsible for single use design, onboarding, and qualification.
* Act as site representative on cross-site teams for standardization of single use assemblies and procedures.
* Work with supplier technical teams to maintain good relationships.
* Technical representative on site cross-functional team for design updates and introduction of new single use to site.
* Author process flow diagrams for new product introductions / technology transfers.
* Responsible for aligning PFD between products and standardizing for NPI. Align with NPI Lead for product transfer on requirements for new products or process improvements.
* Technical SME for investigations, responsible for process improvements and monitoring of process efficiency.
* Author gap assessments, facility fit studies, process safety, and risk assessments for NPI.
* Author scientific reports and technical documentation and presentations to document and communicate project status to internal and external stakeholders.
* Understand and ensure compliance with safety, regulatory, and compliance expectations.
* Other duties as assigned.
What you need to apply:
* 3 years+ biologics experience in aseptic processes, including experience in single use technology and isolator technology.
* Biologics experience with at-scale manufacturing in fill finish facility in a technical role.
* Experience with new product introductions / technology transfers to fill finish manufacturing facility.
* Experience in SAP / Trackwise.
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