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C&Q Consultant

1 month ago

Montreal, Canada PQE Group Full time

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 2000 employees, 45+ nationalities and 40 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means join a multicultural and challenging company with many local and international projects, and colleagues from all over the world.

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Due to a constant growth, we are looking for a Commissioning and Qualification Engineer to join our team and support upcoming projects in Montreal, Quebec in Canada .

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Responsibilities include, but are not limited, to the following

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• Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities.

• Perform system startup, debugging, and initial testing of process and utility systems.

• Ensure that systems are installed and operating according to design specifications.

• Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning.

• Review and verify system documentation, such as P&IDs, wiring diagrams, and datasheets, to ensure compliance.

• Analyze and document test results, highlighting discrepancies or deviations, and provide recommendations for corrective actions.

• Ensure that qualification efforts comply with current Good Manufacturing Practices (cGMP), FDA, and other regulatory standards.

• Support audits and inspections by providing necessary documentation and explanations of qualification processes.

• Prepare risk assessments (FMEA, HAZOP) to ensure compliance with regulatory requirements.

• Develop and maintain accurate project documentation, including commissioning plans, validation protocols, summary reports, and SOPs.

• Create traceability matrices to map qualification activities to design and user requirements.

• Work closely with design engineers, contractors, vendors, and project managers to ensure seamless integration of systems.

• Provide technical guidance and training to operators and maintenance teams on newly commissioned systems.

• Support project planning by providing input on timelines, resource allocation, and risk management.

• Maintain Compliance with training requirements.

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Our ideal candidate should have the following features

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• BS Engineering (or equivalent experience)

• 5+ years of experience in commissioning, qualification, or validation within regulated industries (pharma, biotech, medical devices, etc.)

• Proficiency in reading and interpreting P&IDs, schematics, and technical drawings.

• Knowledge of process automation, SCADA, PLCs, and HMI systems.

• Understanding of utility systems (e.g., HVAC, purified water, steam systems, compressed air).

• Experience with risk management tools like FMEA, HAZOP, or fault tree analysis.

• Strong analytical and problem-solving skills.

• Excellent verbal and written communication skills for protocol writing and reporting.

• Ability to work independently and as part of a multidisciplinary team.

• Strong organizational and time management skills to handle multiple tasks and meet deadlines.

• Experience with software tools such as AutoCAD, Bluebeam, MS Office, or project management software like MS Project.

• Knowledge of validation lifecycle management tools is a plus.

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Next Steps

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Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal.

Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.


Working at PQE Group

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As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.