Careers

Alliston, Ontario

Validation Engineer – Cleaning Validation Specialist

Validation Engineer – Cleaning Validation
Liquid Processing Systems- Pharmaceuticals
Alliston, ON
 

  • Coordinate the validation program to ensure the facility and all equipment, processes and systems are in a validated state of control, by maintaining Validation Master Plans, creating/compiling and/or reviewing validation packages, providing technical expertise and information resources to other departments
  • Subject Matter Expert (SME) on validation to ensure compliance to Regulatory and Corporate requirements.
  • Ensure that validation protocols are written, executed, and documented in accordance with Corporate Quality Policies and Regulatory requirements.
  • Utilize the Trackwise system for Change Control Management practices
  • Create cleaning validation and validation maintenance packages for cleaning procedures, analytical methods and equipment to demonstrate a validated state of control
  • Write protocols, manage the execution of cleaning validation testing plans by liaising with other departments to coordinate cleaning validation activities, compile and analyze data, perform statistical analysis and prepare validation packages
  • Coordinate cleaning validation 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
  • Provide guidance and assistance on cleaning validation formats, requirements and procedures as a team member on various validation projects
  • Support cleaning validation training for team members and provide resource information as a technical expert
  • Review completed validation packages for compliance with validation requirements

Required:

  • Bachelor of Science
  • Science (Chemistry, Microbiology, Pharmacy, Engineering)

Preferred:

  • Experience working with pharmaceutical liquids processing systems

Required:

  • Previous experiences in GMP environment
  • Knowledge of GMP, ISO and Regulatory standards
  • Excellent written & oral communication skills required for writing commissioning & validation test plans, and final reports

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Our Advisor for this position

Wandalin Jana

Talent Acquisition Manager

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