LSC have a great contract opportunity for an Isolator 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.
If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
Experience in authoring, reviewing, executing and approving Isolator Airflow Visualisation/ VHP/HVAC Qualification documents.
Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills: 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.
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 Cian Marnane at LSC on if you have any more questions about this role!
Skills: Equipment Validation Lifecycle Cleaning Validation Controlled Temperature Units