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
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