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Pharmaceutical CQV Engineer

Amaris Consulting

Toronto

On-site

CAD 80,000 - 100,000

Full time

11 days ago

Job summary

A global consulting firm in Toronto is seeking an experienced CQV Engineer to join their team. In this role, you will lead CQV activities for pharmaceutical systems, ensuring compliance with regulatory standards and collaborating with various departments. The ideal candidate has a Bachelor’s degree in Engineering or Life Sciences and experience in CQV within the pharmaceutical industry. This position offers a dynamic work environment and opportunities for personal growth.

Benefits

Strong training system with 250+ modules
Dynamic work environment
Inclusivity and equal opportunities

Qualifications

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

Responsibilities

  • Lead and execute CQV activities for pharmaceutical equipment and systems.
  • Prepare and review CQV documentation, including protocols and reports.
  • Ensure compliance with GMP, FDA, EMA, and other regulatory standards.

Skills

GMP regulations
Problem-solving
Analytical skills
Excellent documentation

Education

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

Tools

HVAC
Autoclaves
Lyophilizers
Bioreactors

Job description

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

Why choose us

  • An international community bringing together more than 110 different nationalities
  • An environment where trust is central: 70% of our leaders started their careers at the entry level
  • A strong training system with our internal Academy and more than 250 modules available
  • A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. We welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

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