Job Description
In this role, you will be leading a small team to write performance and reporting on validation activities related to biopharmaceutical Facilities, Utilities, Equipment (FUE) and associated systems (e.g. automation). You will drive validation activities from initiation to successful completion being the primary decision maker for assigned validation responsibilities, including deviation investigations, risk / impact assessment:
• Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation.
• 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
• At least 8 xears of experience in a Validation/Quality role in a biopharmaceutical manufacturing environment.
• Large scale project experience
• Team player looking for an International Manufacturing Site
• English fluent
Education
Bachelor of Science Degree (BSc) in an engineering or scientific discipline. MSc in a related discipline preferred