CQV Inspector - Manufacturing

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.

• Prepare equipment acceptance test protocols based on Turnkey Modular Systems 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.

• Post-Secondary education in Science or Engineering. Process 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.
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Thorough understanding of good documentation practices (GDP) and good 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.
• Must be mobile within the GTA.
• Flexibility and willingness to travel to the site if needed.

• Quality Assurance
• Engineering
• Clients
• Manufacturing

• Office and Production environment with frequent sitting, standing, and walking around the shop floor.
• Required to use safety and personal protective equipment when on the production floor.
• Some travel to client locations to perform commissioning support and site acceptance testing.
• Some overtime is required.
• Dusty environment.
• Must be capable of working at heights.
• Over time, weekends may be required.
• Required to use safety and personal protective equipment when on the production floor.

At TK Modular Systems, we believe that diversity, equity, inclusion, and belonging are essential to building strong teams and delivering innovative solutions. We are an equal opportunity employer committed to an inclusive and barrier-free recruitment and selection process, as well as a workplace that is free from discrimination.

We encourage applications from all qualified candidates, including women, visible minorities, Indigenous peoples, persons with disabilities, and members of the LGBTQ2S+ community. We are dedicated to creating an environment where every individual feels respected, supported, and empowered to thrive.

Accommodations are available on request throughout the recruitment process in accordance with the Ontario Human Rights Code.

TK Modular Systems complies with the Ontario Employment Standards Act, 2000 (ESA) and all applicable employment laws. We are also committed to upholding the Ontario Human Rights Code, ensuring a workplace and recruitment process that is free from discrimination and barriersp>