Validation specialist

4 weeks ago


Montreal, Canada Capmatic ltée Full time

We are looking for Validation Specialists for our growing team. The validation specialists are responsible for creating equipment validation protocols, and drafting and reviewing validation documents for our packaging machinery. Required documentation includes Design Qualifications, Functional Specifications, Design Specifications, Hardware Design Specifications, Software Design Specifications, Factory and Site Acceptance Tests, Installation Qualifications and Design Qualifications. These documents must be prepared according to cGMP and GAMP standards.

The validation specialist will be responsible for creating tests for equipment functionality, alarms, and production and documenting them effectively. They will also need to work closely with SMEs from other departments to create accurate and understandable content, so highly developed interpersonal skills and the ability to communicate effectively are integral to the job.

All documentation will be written in English, and the writer will be responsible for revising, editing and correcting their own work, therefore they must have strong attention to detail and language accuracy.


This writer will be a university graduate, have an impeccable level of written and oral English, and experience working in quality assurance, quality control, or validation. Knowledge of French (beginner) and strong communication skills are also needed, as is a good knowledge of Microsoft Word and Excel.

Time management skills, the ability to balance different projects simultaneously, adaptability and strong problem-solving skills are all requirements for a successful candidate. This position requires someone who is capable of working independently as well as with a team. We are looking for someone who is committed not only to understanding our existing processes but to improving them on an ongoing basis.

In addition, it would be an asset if the applicant had:

  • experience executing validation protocols
  • experience in dealing with regulatory agencies (Health Canada, FDA, etc.)
  • the ability to read electrical and pneumatic schematics
  • knowledge of 2D and 3D design software

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