Summary:
Our client is a biopharmaceutical company in Waterford looking for a
Process Engineer
who will support manufacturing and drive development and implementation of improvement initiatives in the fill finish manufacturing and development operations.
Responsibilities:
* Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations
* Optimisation of manufacturing and development operations
* Identification & implementation of opportunities for improvements
* Assist in the implementation of capital projects
* Act as process lead for inspection development
* Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams.
* Implementation and monitoring of performance metrics.
* Lead cycle time reduction initiatives in conjunction with manufacturing teams
* Implementation of best practice
* Process development programme design / plant trials, execution and implementation
* Constantly seeking to challenge operational standards and driving continuous improvement.
* Maintain required quality documents in a current compliant state.
* Resource for Clinical supply provision projects
* Aseptic manufacture or oral dose manufacture context
* Design and execution of experimental programmes
* Operation of process laboratories
* Scale-up and technology transfer project role
* Liaison for Clinical supply provision projects
* Liaison for new formulation and product enhancement programmes
* Technical representative for assessment and development of process change control and regulatory submission proposals
* Technical support and trouble-shooting in support of manufacturing activities
* Support of process qualification and process validation activities as required
Qualifications & Experience:
* Degree in Chemical, Industrial or equivalent Engineering discipline
* Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage
* 2 years + experience within Pharmaceutical Development and Manufacturing environment
* OEE/SMED/RCA/CI experience. Technical knowledge of aseptic manufacturing including lyophilisation considered an advantage
* Pharmaceutical product development project life-cycle
* Structured Problem-solving skills – Statistical