Process and Validation Engineer

Description du poste

The Astek Group

Founded in France in 1988, Astek is a global player in engineering and technology consulting. With its expertise in various industrial and tertiary sectors, Astek supports its international clients in the intelligent deployment of their products and services, as well as in the implementation of their digital transformation.

Since its inception, the Group has based its development on a strong culture of entrepreneurship and innovation, and on the support and upskilling of its 7800 employees who are committed every day to promoting the complementarity between digital technologies and complex system engineering.

In Canada, the firm specializes in IT consulting services and engineering. Our teams successfully drive our clients’ development strategies.

Around common values, we have gained their trust and address their business challenges by putting their needs at the center of our actions and priorities.

This ecosystem of expertise enables Astek Canada to adapt quickly to evolving technologies, and all employees participate collaboratively in their development.

Are you ready to take on a new challenge, give your career a boost, and participate in innovative and stimulating projects?

Join a rapidly growing Group in Canada and worldwide that achieved a turnover of €600 million in 2023.

What we will achieve together :

Astek Life Sciences is seeking a highly skilled and detail-oriented Process / Validation Engineer to join our team. The successful candidate will be responsible for overseeing and executing engineering and development runs, validation processes, and protocols to ensure the highest standards of quality and efficiency.

Your mission would be :

• Conduct engineering runs and development runs to test and refine processes.
• Perform validation activities (FAT, SAT, IQ, OQ, PQ, including Process Performance Qualification (PPQ).
• Develop, write, and execute protocols to ensure compliance with industry standards.
• Prepare detailed reports on the outcomes of validation rounds and engineering runs.
• Collaborate with cross-functional teams to ensure seamless integration of new processes.
• Identify and address any issues or deviations during the validation process.
• Maintain thorough documentation of all validation activities and results.

Your profile :

• Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.
• Proven experience in process engineering and validation.
• Strong understanding of validation principles, including PPQ.
• Excellent writing skills for developing protocols and reports.
• Detail-oriented with strong analytical and problem-solving abilities.
• Ability to work independently and as part of a team.
• Strong organizational and project management skills.
• Experience in the pharmaceutical or biotechnology industry.
• Familiarity with regulatory requirements and quality standards FDA , GMP.

Let’s meet!

Do you like our common project?

Apply here and join our team!

Our Advantages :

• A tailored CARE policy deployed by our HR teams for our employees.
• Our Diversity Charter.
• Activities among colleagues such as Teambuilding or Happy Hours.
Il y a 18 jours