Process Validation Engineer

2 weeks ago

Richmond Hill, Ontario, Canada Astek Full time
The Astek GroupFounded 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.

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.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).
  • Execute operations (Upstream and Midstream) using MES and Delta V, while mapping realtime 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.Bachelor's or Master's degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.
  • Proven experience in process engineering and validation.
  • Excellent writing skills for developing protocols and reports.
  • Strong organizational and project management skills.
  • Experience in the pharmaceutical or biotechnology industry.
  • Familiarity with regulatory requirements and quality standards FDA , GMP.

Do you like our common project?Our Advantages:

  • A tailored CARE policy deployed by our HR teams for our employees.
  • Our Diversity Charter.
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