Process Engineer Fill Finish - Life Sciences - Ireland
Our client, a global pharmaceutical company located in the picturesque west coast of Ireland, is seeking a highly skilled Process Engineer to join their state-of-the-art pharmaceutical facility.
Key Responsibilities:
* Design and commissioning input for aseptic fill finish manufacturing equipment.
* Single-use design, onboarding, and qualification expertise.
* Site representative for cross-site teams standardizing single-use assemblies and procedures.
* Collaborate with supplier technical teams to maintain good relationships.
* Technical SME for investigations, process improvements, and monitoring process efficiency.
* Author gap assessments, facility fit studies, process safety and risk assessments.
* Develop scientific reports, technical documentation, and presentations for internal and external stakeholders.
* Maintain compliance with safety, regulatory, and compliance expectations.
Requirements:
* Bachelor's or Master's degree in Chemical Engineering or Bioprocess Engineering.
* Experience in biopharmaceutical industry, particularly with biologics at scale manufacturing in fill finish facilities.
* New product introductions/technology transfers experience to fill finish manufacturing facilities.
* Expertise in single-use technology, isolator technology, and SAP/Trackwise systems.