THE ROLE
* Support Qualification of new equipment into commercial manufacturing
* Execute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standards.
* Investigation/trouble shooting and solution implementation on process and equipment deviations using GPS3 problem solving tools
* Monitoring and review of equipment cycle trends using PI application
* Assist in the implementation of capital projects
* Implement and monitor performance metrics.
* Lead technical problem resolution & RCA (Root Cause Analysis) for all manufacturing operations, in conjunction with cross functional teams.
* Lead cycle time reduction initiatives in conjunction with manufacturing teams
* The main area of work would be on the Aseptic Syringe Filling Line which includes
Debagger
Ebeam
Delid
Deline
Isolator
Syringe filling machine with multi filling technologies
* Lead Process Engineering tech transfer activities for product introduction / transfer to the MFFL Line.
* Provide engineering support to other areas of the process such as
* Dispensing, Formulation, Autoclaving and Washing.
* Provide technical support to implement process improvements, new product transfers to the site and production.
* Design and implement Process development programs through plant trials, execution and change implementation
* Constantly seek to challenge operational standards and driving continuous improvement
REQUIREMENTS
* Honours degree in an Engineering discipline.
* 3 -5 or more years’ relevant experience in a highly regulated GMP environment.
* Experience of Sterile Manufacturing Operations would be an advantage.
* Experience in syringe filling would be a distinct advantage.
Call Louise Mulligan today for further information on 0949003979 or email: lmulligan@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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