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Job Description
Description
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 a 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.
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