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View Cache (Job ID 13850635)
Employer ICDS Recruitment
Job Title Process Validation Engineer

Process Validation Engineer - County Waterford.

Job Purpose:

To ensure process validation activities are completed in line with internal and regulatory procedures and guidelines


• 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 and 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.

Minimum Qualifications & Experience sought:

• 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

This job originally appeared on
Location Waterford
Date Added 67 days ago
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