On behalf of our client, we are actively recruiting for a CQV Inspector for their location in Oakville.
It will be for a day shift and will be ON SITE.
The successful candidate must becurrently eligibleto travel to customer sites in the US if required. SUMMARY: The Commissioning, Qualification & Validation (CQV) Inspector is responsible for performing CQV activities, including project documentation review, execution of equipment acceptance testing, and assembly of documentation turnover packages for custom process equipment, primarily for pharmaceutical and biopharmaceutical applications. DUTIES AND RESPONSIBILITIES: Prepare equipment acceptance test protocols based on company testing standards and client requirements.
Lead the execution of Factory Acceptance Testing (FAT) and/or Site Acceptance Testing (SAT) on finished process systems, including but not limited to the following tasks: Process walk-downs to verify that the system is fabricated as per the engineering detailed design documents; Component verification; Piping Slope verification; Instrument and valve functionality tests; Electrical and control system checks; and Equipment documentation review.
Work with the validation team to review welding documentation, vessel documentation, component certification, and engineering documentation.
Assemble physical documentation binders and electronic turnover package based on vendor documentation requirements.
Assist receiving inspectors in performing inspection and documentation activities.
Maintain action lists / punch lists. QUALIFICATIONS: Post-Secondary education in Science or Engineering is preferred.
Minimum 2-year relevant work experience which demonstrates knowledge of validation principles, including: validation planning, user requirements and functional specifications, commissioning, IQ, OQ, PQ for pharma and biotechnology industries.
Thorough understanding of good documentation practices (GDP) and valuable manufacturing practices (GMP).
Knowledge of biopharmaceutical/nuclear industry standards and guidelines.
Detail-oriented and strong organizational skills.
Possess initiative and ability to interact with a variety of disciplines and production teams.
Effective problem solving, root cause analytical skills.
Strong written and verbal communication skills.
Strong computer skills with experience using MS Office and Adobe PDF editor.
Some travel to client locations (including the US) to perform commissioning support and site acceptance testing.