Process Scientist - Validation
Summary
A Process Scientist (Validation) is required to join a leading biotechnology manufacturing company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.
This role will be responsible for supporting the Manufacturing Support Process Sciences Department with analysis, troubleshooting, and Process Validation of manufacturing bioprocesses. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical/Biotech industry.
Key Responsibilities
- 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/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.
Interested in an exciting change this year?
For more information on this and other positions please contact Jack on jack.conway-kenny at experis.ie or call 016455250
