We are looking for a Process Scientist/Engineer (Single Use) to join our client's Technical Operations Team in Sligo. You will work closely with site cross-functional teams and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes. This position reports to the NPI Technical Manager. This is an exciting time to join our Technical Operations team as we grow and bring new products and technologies to the site. To be successful in this role you need to be initiative-taking, have strong collaboration skills and be able to work to strict project timelines.
Roles and Responsibilities
* Work closely with site cross-functional team and global science and quality teams on the development and evolution of the single use materials used in the product path for biologics manufacturing processes.
* Lead and / or assist risk assessments for the introduction or modification of the product path 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 process 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 the product path.
* 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 analyse process data during the 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.
Qualifications
* 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
* Experience in client-facing role collaborating with vendors and global stakeholders to advance.
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