• 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.

Requirements:

• 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.