Senior Validation Engineer, Process Equipment
Biogen
Solothurn,Switzerland
vor 22 Tg.

Summary

If you join our new biological site, you will be leading a team to drive validation activities related to Facilities, Utilities, Equipment (FUE) being the subject matter expert, primary decision maker within your area of responsibilities.

Responsibilities, include deviation investigations, risk / impact assessment.

Job Description

  • Preparation and execution of validation protocols
  • Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation.
  • Management and co-ordination of validation activities with internal departments, external contractors and suppliers.
  • Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities.
  • Primary point of contact for validation related issues arising during validation activities (including protocol execution).
  • Investigation of deviations / non-conformances to determine potential impact on product quality, validation status and associated compliance requirements.
  • Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required).
  • Represent validation as a subject matter expert (SME) in all project phases (including commissioning and qualification execution).
  • Qualifications

  • You have 8 to 10 years of experience in a Validation / Quality role within Biopharmaceutical manufacturing environment.
  • You have worked in Large Scale Manufacturing environment
  • Your English is fluent and ideally have some good basis of German
  • Education

  • Bachelor of Science Degree (BSc) in an engineering or scientific discipline. MSc in a related discipline preferred.
  • Mid-Senior Level

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