Process Engineer Job Description
We are seeking a highly skilled Process Engineer to join our team at PE Global, working with a leading biopharmaceutical client based in Sligo.
Job Role:
* 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.
Requirements:
* Third level degree in Chemical Engineering, Bioprocess Engineering
* 3-5 years' experience in biopharmaceutical industry.
Essential Skills:
* 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 / Track wise
This is an initial 12-month contract position.
The successful candidate will have a strong background in process engineering, with a proven track record of delivering projects on time and within budget.
We are looking for a talented individual who can work effectively in a team environment, communicate complex ideas clearly, and demonstrate excellent problem-solving skills.