A Process Simulation Engineer is required by CareerWise Recruitment to join our Biotech clients based in Carlow – an 11 month initial contract role. You will be responsible for providing process, technical, and validation support to operations for Process Simulation development and execution
ROLE:
* Serve as technical support for manufacturing and new product introduction.
* Design/Author/Review/Approve/Execute process simulations studies in support of new
product introduction and ongoing manufacturing support.
* Provide technical input into quality notification by authoring/reviewing/approving
Process Simulation related investigations.
* Design/Author/Review/Approve/Execute process simulation qualification/validation
documentation and studies in line with the standard approval process
* Perform data analysis and make informed decisions/recommendations around conclusions
reached from data analysis
* Support continuous improvement through Lean Six Sigma methodologies.
* Leading and active participation in projects, system failure investigations and investigation reports.
* Execution/development of change controls to support the Process Simulation process
* Contribution to Kaizen events as appropriate.
* Perform root cause analysis of system failures, substandard performance, using standard
tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams,
5 why’s etc.
REQUIREMENTS:
* 3 - 5 year’s operations experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution.
* Demonstrated ability to coach and lead change
* Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment
* Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical
Discipline
Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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