Process and Validation Engineer

1 month ago

North York, Canada Astek Full time

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:

- Support client in execution, documentation, and troubleshooting vaccine manufacturing operations.

- Perform validation activities (FAT, SAT, IQ, OQ, PQ, including Process Performance Qualification (PPQ).

- Plan and execute validation runs, identify and map potential and observed issues.

- Execute operations (Upstream and Midstream) using MES and Delta V, while mapping real-time data using Pi Vision.

- Draft, review and publish reports out of the executed runs, and project potential process improvements.

- Execute and investigate Non-Conformances/ Deviations, and drive Change Management through Change Controls.

- Communicating and coordinating activities across departments including QA, QC, Automation, Engineering, Operations, C&Q, and ITS.




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.

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