Process Engineer

4 weeks ago


Sligo, Ireland TEAM HORIZON Remote Work Freelance Full time
Description

Team Horizon is seeking a Process Engineer (Fill Finish) on an initial 12-month contract, for our client in Sligo who are a global biopharmaceutical company. In this role, you will report to the NPI Technical Manager and work in the Technical Operations team.
 
Why you should apply:



This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

 
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 crossfunctional 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.
Any other duties as assigned.

 
What you need to apply:



Third level degree in Chemical Engineering, Bioprocess Engineering, or equivalent with 3-5 years experience (BSc) or 2-5 years experience (MSc) in biopharmaceutical industry.
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.

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