Process Equipment Validator

3 days ago

Candiac, Quebec, Canada Pharmascience Full time

Job Summary

The Process Equipment Validator will participate in the qualification of equipment and systems associated with the sterile product manufacturing line. He or she will act as a validation project coordinator and ensure that all stages of the validation project are followed.

Main Responsibilities

  1. Develop and execute validation protocols for process equipment and systems
  2. Perform or supervise tests required by qualification protocols
  3. Manage documentation relating to validation activities, including filing, updating, and preparation of files
  4. Manage protocol revisions and approvals, and participate in the resolution of validation deviations
  5. Participate in change control follow-up for validated equipment and systems
  6. Develop and revise standard operating procedures (SOPs)
  7. Work closely with the project engineering team and write technical notes
  8. Evaluate changes to validated systems
  9. Support audits and visual inspections when required
  10. Perform periodic requalifications

Required Skills and Knowledge

  1. Excellent technical writing skills
  2. Fluency in English and French (oral and written)
  3. Good problem-solving skills
  4. Excellent communication skills
  5. Proficiency in Microsoft Office software
  6. Knowledge of SAP, Trackwise, and other electronic documentation management systems
  7. Dynamic and autonomous
  8. Ability to manage several projects simultaneously
  9. Knowledge of automated and computerized systems qualification
  10. In-depth knowledge of GMPs and regulatory requirements for validation/qualification of sterile product production equipment and systems

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