Validation Engineer

4 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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