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Sr. Validation Engineer

Engineering
Bern
English

For our client, an international company based in Bern, we are looking for a motivated Sr. Validation Engineer.

In this role, you will be responsible for Validation activities for (new) biopharmaceutical processes in the Late Stage Development department.


General Information:

  • Start date: ASAP
  • End date: limited to approx. 6 months
  • Extension: possible, to be discussed
  • Workplace: Bern
  • Workload: 100%



Tasks and Responsibilities:
 

  • Define strategy, plan, coordinate and execute all phases for supporting validation activities such as (but not limited to) sterilization in place, autoclave load validation, washing machine cleaning validation, buffer hold time.
  • Define strategy, plan, execute and coordinate sterility assurance relevant supporting validation activities such as (but not limited to) smoke studies in operations, CCIT, sterile hold time, vessel integrity and filter validation.
  • Define strategy, plan, execute and coordinate of cleanrooms performance qualification.
  • Define strategy, plan, execute and coordinate of process equipment performance qualification.
  • Supporting engineering, quality, quality control and production in a campus-wide validation team.
  • Coordination and oversight of external validation partners.



Qualifications and Skills:
 

  • MSc degree (or BSc with increased level of experience: 5-7 years) in technical or life sciences
  • A minimum of 3-5 years of working experience within pharma company in validation or equivalent position
  • Experience working in project teams
  • Experience in project management is a plus
  • Profound k-how of Validation requirements according to cGMP regulations
  • Basic K-how of biotechnology processes
  • Analytical thinking and problem-solving ability
  • Fluent in English (German is a plus)