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Résumé du poste

Lead and execute commissioning, qualification, and validation (CQV) activities for pharmaceutical equipment, utilities, and systems. Prepare and review CQV documentation, ensuring compliance with global regulatory standards.

Détails du poste

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. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics. 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!

Ce que vous ferez

Lead and execute commissioning, qualification, and validation (CQV) activities for pharmaceutical equipment, utilities, and systems. Prepare and review CQV documentation, ensuring compliance with global regulatory standards.

Exigences

A bachelor's degree in Engineering, Life Sciences, or a related field is required, along with proven experience in CQV within pharmaceutical or biotech manufacturing environments. Strong knowledge of GMP regulations and experience with various pharmaceutical systems are also necessary.

Compétences indiquées

• Validation · Souhaitée
• Analytical · Souhaitée
• Recruitment · Souhaitée
• assessment · Souhaitée
• Résolution de problèmes · Souhaitée
• Teams · Souhaitée
• Compliance · Souhaitée
• Execution · Souhaitée
• Process · Souhaitée
• Documentation · Souhaitée
• future · Souhaitée
• nurturing · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• CQV
• GMP Regulations
• Problem-Solving
• Analytical Skills
• Documentation
• Collaboration
• Pharmaceutical Equipment
• Utilities
• Systems
• Risk Assessments
• Troubleshooting
• FAT/SAT Execution
• Clean Utilities
• HVAC
• Autoclaves
• Bioreactors

Domaines d’emploi

• Engineering
• Healthcare
• Consulting