Validation Engineer

3 weeks ago

Alliston, Canada ALTEN Canada - Toronto division Full time
Location: Alliston, ON (Onsite)

Job Description: Support their PPB (Plastic Pour Bottle) Machine - blow fill / seal technology Define the proper setup for each equipment/machine on the process Testing with different parameters and with the existing previous process Work with QA to write procedures (SOP) which will be given as instructions to operators on the production line. Create validation packages for systems, processes, cleaning procedures, analytical methods and equipment to demonstrate a validated state of control Write protocols, manage the execution of validation testing plans by liaising with other departments to coordinate validation activities, compile and analyze data, perform statistical analysis and prepare validation packages Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors providing leadership, training and guidance Monitor and support the execution of the protocols through training, facilitating and problem solving activities

Requirement: Experience in validation of pharma equipment regulation & standards (FDA / health Canada) knowledge Process Validation or Equipment Validation experience would be ideal Equipment from a filling process is a ++ as well as if they have worked on computer system validation

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