Process and Validation Engineer

2 weeks ago

Richmond Hill, Ontario, Canada Astek Full time

Astek Group - Engineering and Technology Consulting Company

The Astek Group was established in France in 1988 and has since become a major player in the global engineering and technology consulting industry. With expertise across various industrial and tertiary sectors, Astek assists international clients in smartly rolling out their products and services, as well as executing their digital transformation efforts.

Having a strong foundation in entrepreneurship and innovation, the Group focuses on supporting and enhancing the skills of its 7800 employees. These employees are dedicated to bridging the gap between digital technologies and complex system engineering on a daily basis.

In Canada, Astek specializes in providing IT consulting services and engineering solutions. Our dedicated teams effectively drive our clients' growth strategies. By prioritizing their needs, we have earned their trust and tackled their business challenges together.

This collaborative environment allows Astek Canada to swiftly adapt to advancing technologies, with all team members actively contributing to their progress.

What we will achieve together:

Astek Life Sciences is currently looking for a meticulous and highly skilled Process/Validation Engineer to join our team. The ideal candidate will oversee and carry out engineering and development runs, validation processes, and protocols to ensure top-notch quality and efficiency.

Your mission:

  • Support clients in executing, documenting, and resolving issues in vaccine manufacturing operations.
  • Conduct various validation activities, including Process Performance Qualification (PPQ).
  • Plan and implement validation runs, identify potential issues, and map observed problems.
  • Utilize MES and Delta V for operations, while using Pi Vision to track real-time data.
  • Create, review, and share reports based on the conducted runs, suggesting process enhancements.
  • Handle Non-Conformances/Deviations and lead Change Management through Change Controls.
  • Coordinate activities across multiple departments such as QA, QC, Automation, Engineering, Operations, C&Q, and ITS.

Your profile:

  • Holds a Bachelor's or Master's degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology disciplines.
  • Demonstrated experience in process engineering and validation fields.
  • Solid grasp of validation principles, including PPQ.
  • Proficient in crafting protocols and reports with excellent writing abilities.
  • Detail-oriented with exceptional analytical and problem-solving skills.
  • Capable of working autonomously and collaboratively within a team.
  • Strong organizational and project management capabilities.
  • Previous exposure to the pharmaceutical or biotechnology sectors.
  • Familiarity with FDA regulations, GMP standards, and other quality requirements.

If you are excited about this opportunity and wish to contribute to our shared project, apply now to join our team

Our Advantages:

  • A customized CARE policy implemented by our HR teams for all employees.
  • Our Diversity Charter.
  • Team activities like Teambuilding and Happy Hours to foster a sense of camaraderie.

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