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Validation Engineer/Autoclave load validation engineer

Michael Bailey Associates - UK Contracts

Posted on Apr 6, 2022 by Michael Bailey Associates - UK Contracts

Bern, Switzerland
Engineering
2 May 2022
Annual Salary
Contract/Project

A Pharma company in Switzerland is looking for a Validation Engineer/Autoclave load validation engineer to join their Late-Stage development department. If you are interested and want to know more details, send and application and we'll be in touch!

Main Responsibilities:

In this role, you will be responsible for Validation activities for (new) biopharmaceutical processes in the Late-Stage Development department. Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.

  • Define strategy, plan, coordinate and execute all phases for performance qualification of process equipment.
  • Define strategy, plan, coordinate and execute all phases for supporting validation activities such as autoclave load validation, sterilization in place validation or temperature mapping validation studies.
  • Bridging with cross-functional teams handling and ensuring equipment and process readiness for production
  • Create, review and approve technical and GMP related documentation.
  • Supporting engineering, quality, quality control and production in a campus-wide validation team.
  • Coordination and oversight of external validation partners.

Requirements:

  • Analytical thinking and problem-solving ability
  • Basic Know-how of biotechnology processes
  • University degree in natural or technical sciences or equivalent by experience
  • Work experience within a pharma or a biotech company
  • Know-how of Qualification/Validation requirements according to cGMP is a major plus.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Reference: 1557365324

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