Process Validation Scientist

  • Reference: GY44989AO
  • Job Type: Permanent
  • Location: Limerick
  • Category: Science, Pharmaceutical & Food

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
• Understand and Applies statistical tools for development of protocols and data analysis for Process Validation.
• Present Process Validation documents at regulatory audits
• 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
• 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.

For a confidential discussion and more information on the role/company please  email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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  • Amy O’Neill
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  • 091706718
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