Our client, a leading pharmaceutical company based in Limerick currently has an opportunity for a Process Scientist – Process Validation to join their team. This is a full-time, permanent position offering an excellent salary and benefits package.
Summary: Supports the Process Sciences Department with analysis, troubleshooting, and Process Validation of manufacturing bioprocesses.
Essential Duties and 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
Understand and Applies statistical tools for development of protocols and data analysis for Process Validation.
Technical and Scientific expertise 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
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.
For more information on this position please call Rachael O’Rourke on 061336136 or apply online and a member of the Harmonics team will be in touch