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Process Scientist - Process Validation

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 05/03/2018
  • Job reference: J382645A

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Our client, a global bio-pharmaceutical manufacturing company in Ireland's south-west, are recruiting for a Process Scientist (Validation) to join their growing team.

The successful candidate will be tasked with supporting the 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.

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