Senior Process Manager - Life Sciences
Join our client, a leading global pharmaceutical company, in their new large-scale facility in Dublin. This is a fantastic opportunity to be part of a fast-paced project, with lots of opportunities to work with and learn about cutting-edge technologies.
This project is truly exciting as it will contribute to the manufacturing of a life-changing treatment.
Responsibilities:
* Support the design, construction and qualification of upstream & downstream equipment.
* Support establishment of the commercial process and routine manufacturing by:
1. Supporting experimental design, execution, data analysis and interpretation.
2. Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
3. Supporting deviation management.
4. Supporting change control prioritisation and implementation.
5. Authoring and reviewing of batch documentation, technical reports and global regulatory submissions.
6. Supporting multidisciplinary teams for process improvement and troubleshooting with end-to-end product focus.
7. Applying Lean Six Sigma tools by:
* Safeguarding continuity of an appropriate LSS/CEM level of knowledge.
* Facilitating problem solving & risk assessment (FMEA) projects/meetings.
* Making problems visible and strive for continuous improvement.