Project Process Engineer

Project Process Engineer

Team Horizon is seeking a Project Process Engineer for a Pharmaceutical manufacturing company in Sligo.

Will be based at the fill finish site, involved in filling line processes, investigations/evaluations of new products, monitoring process efficiency and KPI's, tracking trends, gap assessments for new products, 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 relationship.


• Technical representative on site cross-functional team for design updates and introduction of new single use to site.


• Author of process flow diagrams for new product introductions / technology transfers.


• Responsible for aligning PFD between products and standardizing for NPI. Aligns 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, 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 single use technology Experience in isolator technology Experience in SAP / Trackwise.