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.
- 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.
- Degree in an Engineering or Science discipline.
- Statistical packages, e.g. Minitab
- Analytical Techniques
- Pharmaceutical solid dose manufacturing
For further information on this role please contact James on 016455250 or email@example.com