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.
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).
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
Bachelor of Science Degree (BSc) in an engineering or scientific discipline. MSc in a related discipline preferred.