Collins McNicholas

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.

 

Summary:  

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:

 

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.

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.

For a confidential discussion on the above role please contact Michael O’Leary on 061-512270

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