Pharmaceutical CQV Engineer

MANTU GROUP SA; Toronto; On-site; CAD 70,000 - 100,000; Full time

Job summary

A leading consulting firm is seeking experienced CQV Engineers in Toronto to contribute to critical pharmaceutical projects. The role involves leading CQV activities, preparing documentation, and ensuring regulatory compliance. Candidates should have a background in Engineering or Life Sciences, and proven experience in highly regulated environments.

Qualifications

• Proven experience in CQV within pharmaceutical or biotech manufacturing environments.
• Strong knowledge of GMP regulations (ISPE, ASTM E2500).
• Ability to work independently and collaboratively in a highly regulated environment.

Responsibilities

• Lead and execute commissioning, qualification, and validation activities for pharmaceutical equipment.
• Prepare and review CQV documentation including protocols and risk assessments.
• Ensure compliance with GMP, FDA, EMA, and other global regulatory standards.

Skills

Problem Solving

Analytical Skills

Documentation Skills

GMP Knowledge

Education

Bachelor’s degree in Engineering, Life Sciences, or a related field

Tools

Clean utilities

HVAC

Autoclaves

Lyophilizers

Bioreactors

Job description

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!

Job description

Are you an experienced CQV professional looking to contribute to critical pharmaceutical projects? We are currently seeking CQV Engineers to join our growing team in Toronto! If you're open to exciting new opportunities and thrive in fast-paced, highly regulated environments, we’d love to hear from you.

Responsibilities:
Lead and execute commissioning, qualification, and validation (CQV) activities for pharmaceutical equipment, utilities, and systems
Prepare and review CQV documentation, including protocols (IQ/OQ/PQ), reports, and risk assessments
Ensure compliance with GMP, FDA, EMA, and other global regulatory standards
Collaborate with cross-functional teams including QA, Engineering, Manufacturing, and Project Management
Troubleshoot systems and support investigations for deviations and non-conformances
Participate in FAT/SAT execution and system handover processes

Requirements:
Bachelor’s degree in Engineering, Life Sciences, or a related field
Proven experience in CQV within pharmaceutical or biotech manufacturing environments
Strong knowledge of GMP regulations and industry standards (ISPE, ASTM E2500, etc.)
Experience with equipment and systems such as clean utilities, HVAC, autoclaves, lyophilizers, and bioreactors
Excellent documentation, problem-solving, and analytical skills
Ability to work independently and collaboratively in a highly regulated environment