This is an exciting opportunity where you will support the Manufacturing Support Process Sciences Department with analysis, troubleshooting, and Process Validation of manufacturing bioprocesses. This role will be key to the business evolution and work with senior management within the organisation.
The Role
- 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.
Requirements
- 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.
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