Summary:Supports the Manufacturing Support Process Sciences Department with analysis, troubleshooting, and Process Validation of manufacturing bioprocesses.
Essential Duties and Responsibilities may include, but are not limited to, the following:
• Supports all Process Validation activities
• Define Process Validation Strategies
• Author, review and approve Process Validation protocols and reports
• Schedule and support Process Validation executions
• High level of technical and scientific writing required
• Present Process Validation documents at regulatory audits
• Technical and Scientific experience in cell culture and downstream operations for daily monitoring, troubleshooting and investigations
• Performs scientific process investigations with relevant departments as required.
• Provide technical floor support for Manufacturing operations
• Performs product and process impact assessments.
• Participates in or Lead process and quality risk assessments
• Presents findings at group and at interdepartmental meetings
• Communicate information on current process data which may impact Process Validation.
Education and Experience:
• PhD in Biotechnology, Biochemistry, or a related field with 0-2 years’ experience; may consider another discipline with added relevant experience. cGMP experience is desirable. Relevant Quality Assurance experience is desirable.
• Candidates with an MSc in Biotechnology or a related field with 3+ year’s relevant experience will also be considered.
If you would like further Information you can contact the recruiter directly:
Libby Ryan | Tel: +353 (0) 1 507 9254