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Process Validation Engineer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Scientific
  • Date posted: 13/03/2017
  • Job reference: J363256A

Process Validation Engineer

Our client is seeking a Process Validation Engineer to ensure process validation activities in the facility are completed in line with internal and regulatory procedures and guidelines in a pharmaceutical environment.

Responsibilities:

  • Write and execute protocols and reports for the validation of new and existing processes. Including, but not limited to, Process Validation protocols, Validations reports, Continuous Process Validation Reports.
  • Compile summary reports based on executed protocols, following good documentation practices report structures.
  • Liaise with contractors/ customers when external resources are required to complete validations.
  • Liaise with relevant departments to ensure validation activities are planned and executed in line with applicable deadlines.
  • Assist with the generation of metrics for the Technical Services department
  • Assist with submission/ deficiency responses activities when required, in a timely manner.
  • Draft/ revise/ review SOPs.
  • Analyse statistical data to verify acceptable criteria.
  • Develop testing strategies and rationale for manufacturing processes.
  • Provide technical support/troubleshooting for process and equipment issues.
  • Apply cGMP guidelines to all aspects of validation.
  • Investigate/resolve deviations associated with validation studies.

Requirements:

  • Degree in an Engineering or Science discipline.

Skills:

  • Statistical packages, e.g. Minitab
  • Analytical Techniques
  • Pharmaceutical solid dose manufacturing

For further information on this role please contact James on 016455250 or james.kelly@experis.ie

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