We are looking for dynamic consultants to grow our Life Sciences team in Toronto. Your experience, knowledge, and commitment will help us to face our client's challenges.
You will be supporting different projects through your expertise as CQV Engineer.
Your main responsibilities:
- Lead and execute commissioning, qualification, and validation activities for pharmaceutical manufacturing equipment, systems, and processes
- Develop and execute CQV protocols (IQ, OQ, PQ) in compliance with regulatory standards and company procedures.
- Generate and review validation documentation, including protocols, reports, and deviations
- Utilize your expertise in automation systems, such as Delta V and other Manufacturing Execution Systems (MES), to configure, troubleshoot, and optimize automated processes
- Collaborate with cross-functional teams to ensure seamless integration of automation systems with manufacturing processes
- Participate in the development and implementation of software test scripts for automation systems
- Identify opportunities for process improvement and optimization to enhance efficiency, quality, and compliance within the manufacturing environment
- Analyze data from manufacturing processes and automation systems to identify trends and areas for enhancement
- Ensure that all commissioning, qualification, and validation activities adhere to relevant regulatory requirements (FDA, GMP, etc.)
- Support regulatory inspections by providing accurate documentation and information related to CQV activities
- Bachelor's degree in Engineering, Pharmaceutical Sciences, or related field. Master's degree is a plus
- Minimum of 6 years of experience in commissioning, qualification, and validation within the pharmaceutical or biotech industry
- Strong experience with automation systems, such as Delta V, and proficiency in Manufacturing Execution Systems (MES)
- In-depth understanding of regulatory requirements and guidelines (FDA, GMP, etc.) pertaining to pharmaceutical manufacturing and validation
- Proven ability to lead and execute CQV projects, including protocol development, execution, and documentation
- Excellent problem-solving skills and the ability to troubleshoot complex automation and process-related issues
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, 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 1000 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 7500 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!