Process Validation Engineer

ICDS Recruitment

Waterford

Process Validation Engineer. We welcome applications from persons who meet the following criteria: Degree in an Engineering or Science discipline. Experience of any or all of the following is desirable: Process Validation. Statistical packages, e.g. Minitab. Analytical Techniques. Pharmaceutical solid dose manufacturing. Responsibilities include: 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. This job originally appeared on RecruitIreland.com.

2657 days ago