Job Title
Process Scientist / Engineer
We are seeking a highly skilled Process Scientist / Engineer to join our team in Sligo. The successful candidate will work closely with site cross-functional teams and global science and quality teams on the development and evolution of single use materials used in biologics manufacturing processes.
Why You Should Apply:
* This is an excellent opportunity to be part of a world-class manufacturing operation, with a strong track record of delivering high-quality medicines to patients around the world suffering serious illnesses.
* This is an exciting time to join our team as we grow and bring new products and technologies to the site.
* Our team has a strong culture of continuous improvement and innovation to strive for solutions that improve health outcomes and dramatically improve people's lives.
* We are developing the capability to produce all our medicines, ensuring continuity of supply of our medicines as we expand internationally.
Job Responsibilities:
* Work closely with site cross-functional teams and global science and quality teams on the development and evolution of single use materials used in biologics manufacturing processes.
* Lead and/or assist risk assessments for the introduction or modification of product paths including single use materials (e.g., pFMEA, SU RA, E&L assessment) including required change management activities.
* Interact with manufacturers and vendors on best practices and validation packages, and function as technical lead for SU complaints.
* Assist with the development of manufacturing processes for new products including developing and/or reviewing process related documents e.g., Protocols/Procedures/Manufacturing Batch Records.
* Prepare and update specifications related to NPI materials and consumables, including single use materials used in product paths.
* Provide operational technical support for process-related issue resolution, design experiments to investigate new processes or failure modes, assist and/or lead single use process-related investigations.
* Monitor and analyze process data during manufacturing.
* Support, supervise, and train operations personnel for SU processes.
* Adhere to and support all EHS&E standards, procedures, and policies. Other duties as assigned.
Requirements:
* Degree in science, engineering, or other relevant technical subject area
* 2+ years direct experience in the use of single use materials for biologics manufacturing in GMP environment e.g., in operations, technical operations, and process validation.
* 1+ years experience in the design, onboarding, and qualification of single use assemblies for biologics manufacturing