Process Engineer  Fill Finish

Our client is a global multinational biopharmaceutical company seeking to recruit a Process Engineer for their busy Fill Finish plant. The newly appointed Process Engineer will be a specialist in critical process parameters and product quality attributes / Key team member for process development and product transfer projects. You will report to Process Engineering Manager Fill Finish and will be a resource for new product introductions / enhancement development projects, and for Clinical supply provision projects

Key Contacts will include ( internal ) Fill Finish Manufacturing and Maintenance Team members , QA / QC / Validation / Regulatory / EHS and Finance and ( external ) Equipment vendors, component suppliers, other company sites

Key Accountabilities

 

• Subject Matter Expert for product quality attributes and process critical parameters
• Design and execution of experimental programmes
• Scale-up and technology transfer project role
• Process development programme design, execution and implementation
• Liaison for Clinical supply provision projects
• Liaison for New formulation and product enhancement programmes
• Operation of Process Laboratory
• 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 validation activities as required
• Compliance with sites change control process
• Perform all activities in compliance with cGMP

Key Performance Indicators

• Achievement of project SMART goals
• Successful Product Transfer achievements
• Continuous improvement activities yielding advancement in quality and reliability
• Deviation closure within 45 days

 Person Spec :

 

The preferred candidate will have an advanced degree in Pharmaceutics, Pharmacy or related Science discipline as well as 2 years + experience within Pharmaceutical Development and Manufacturing environment

 

• Technical knowledge(theory and practice) of aseptic manufacturing including lyophilisation
• 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
• Problem-solving skills

CV to gerry@rftgroup.ie   Gerry Kennedy   www.rftgroup.ie   01 2302400