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Validation Specialist for Process Equipment

1 month ago

Candiac, Quebec, Canada Pharmascience Full time

The Validation Specialist, Process Equipment, plays a crucial role in ensuring the quality and reliability of equipment and systems used in the sterile product manufacturing line at Pharmascience. This position involves coordinating the qualification of equipment and systems, acting as a validation project coordinator, and ensuring that all stages of the validation project are followed.

Key Responsibilities:

  • Develop and implement qualification protocols for equipment and systems
  • Perform or supervise tests required by qualification protocols
  • Manage documentation related to validation activities, including filing, updating, and preparation of files
  • Manage protocol revisions and approvals, and participate in the resolution of validation deviations
  • Participate in change control follow-up for validated equipment and systems
  • Develop and revise standard operating procedures (SOPs)
  • Collaborate with the project engineering team and write technical notes
  • Evaluate changes to validated systems
  • Support audits and visual inspections as required
  • Perform periodic requalifications

Requirements:

  • Excellent technical writing skills
  • Fluency in English and French (oral and written)
  • Good problem-solving skills
  • Excellent communication skills
  • Proficiency in Microsoft Office software
  • Knowledge of SAP, Trackwise, and other electronic documentation management systems
  • Dynamic and autonomous
  • Ability to manage several projects simultaneously
  • Ability to develop all required validation documents
  • Knowledge of automated and computerized systems qualification
  • In-depth knowledge of GMPs and regulatory requirements for validation/qualification of sterile product production equipment and systems