Process Engineer

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