Process Engineer (Fill Finish)

Role Summary:

• Provide leadership and support to operations teams to ensure appropriate standards are met.
• Development and implementation of improvement initiatives in all manufacturing and development operations

Core Duties and 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.
• Ability to multi task and prioritize workload.
• Maintain required quality documents in a current compliant state.
• Subject Matter Expert for and team resource for new product introductions / enhancement development projects
• Resource for Clinical supply provision projects
• Aseptic manufacture or oral dose manufacture context
• Subject Matter Expert for product quality attributes and process critical parameters
• 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
• Process/product deviation investigation and resolution
• Technical report writing
• Training delivery of technical training programmes
• Support of process qualification and process validation activities as required

Minimum Qualifications and 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(theory and practice) of aseptic manufacturing including lyophilisation considered an advantage
• Design of Experiment and associated statistical techniques
• Pharmaceutical product development project life-cycle
• Strong report-writing and verbal communication skills
• Laboratory and pilot plant skills
• Research skills
• Innovation and creativity skills
• Project management skills
• Structured Problem-solving skills – Statistical

Please note, we do not require agency assistance with this role.