LSC have a great contract opportunity for a Validation Engineer to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
Responsibilities:
- Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
- Design/Author/Review/Approve/Execute Execution/development of change controls.
- Resolving technical issues encountered during study execution.
- Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
- Technical input into quality notification by authoring/reviewing/approving investigations.
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
- Support continuous improvement through Lean Six Sigma methodologies.
- Serve as validation representative for cross functional projects and represent the validation team at global technical forums
In order to excel in this role, you will more than likely have:
- Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
- Knowledge of CTU equipment qualification
- Knowledge of thermal mapping equipment
- Thermal mapping skills
- Exception / Deviation Management and Change Control.
- Demonstratable experience of leading technical related projects.
- Sterile Fill-Finish processes and equipment.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Siobhan Cummins at 0214777329 if you have any more questions about this opportunity!
