Collins McNicholas currently have an exciting opportunity for a Process Scientist – Manufacturing Support & Process Validation with one of their clients in the Mid-West Region. This role is a permanent position.
Supports the Manufacturing Support Process Sciences Department with analysis, troubleshooting, and Process Validation of manufacturing bioprocesses.
The following are the key requirements for 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.
- 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.
For a confidential discussion on the above role please contact Michael O’Leary on 061-512270