PROCESS VALIDATION ENGINEER

Job Purpose: To ensure process validation activities at EirGen Pharma are completed in line with internal and regulatory procedures and guidelines

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 EirGen departments to ensure validation activities and 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.

Minimum Qualifications & Experience

  • Degree in an engineering or science discipline.
  • Experience and knowledge of any or all of the following is desirable: Process validation Statistical packages, e.g. Minitab Analytical techniques Pharmaceutical solid dose manufacturing