Process Validation Engineer (closed)
- Process Validation against Corporate SOP/FDA/EMEA requirements.
- Accountable for writing, executing & reporting validation documentation (DQ / FAT / IQ / OQ / PQ / PPQ / pFMEA).
- Execution and documenting of process risk assessment / failure mode and effects analysis.
- Statistical analysis of data to determine process capability through Cpk and other statistical techniques.
- Performing of validation functional testing as required.
- Track and resolve exceptions during qualification activities.
- Partcipate in cross functional teams.
- Ensure all information is recorded correctly and compliant with GDP.
- Assist in execution of validation protocols.
- Development of project plans to validate processes.
- Validation projects will be across a range of production areas which may include automation, filling, mixing, cleaning, software, utility and facility projects.
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Min 3-5 years experience in validation in an automated/pharma manufacturing environment.
- In-depth knowledge of validation processes.
- Knowledge of Pharma/Medical product manufacturing, especially automated processes or filling operations.
- Project Management skills.
- Excellent interpersonal, communication & technical report writing skills
- Experience in process, software, filling and automation process validation.
- Experience with Minitab or similar stastical package.
- Must be flexible and able to manage multiple priorities simultaneously.