Job Description
We are seeking a highly skilled professional to join our cutting-edge biologics manufacturing facility in Dublin. As a key member of our team, you will play a crucial role in new product introduction (NPI), supporting cross-functional teams to implement process improvements, manage technology transfers, and ensure smooth transitions for new product manufacturing.
Key Responsibilities:
* Collaborate across Manufacturing, QA, QC, and Engineering to support NPI projects.
* Conduct risk assessments and write process impact assessments for new products.
* Support process technology transfer and prepare documentation for PPQ batches.
* Drive process improvements, manage change controls, and minimize human error.
* Provide SME input for new processes, procedures, and raw material introduction.
Qualifications:
* Bachelor's or Master's in Science, Engineering, or a related field.
* Strong knowledge of GMP biologics manufacturing equipment and process automation.
* Experience with Delta V, MES Syncade, SAP, and lean manufacturing principles.
* Excellent communication, problem-solving, and project management skills.
Requirements
To be successful in this role, you must have a strong understanding of biologics manufacturing processes and experience working in a similar environment. You should also be able to communicate effectively with cross-functional teams and adapt to changing priorities.