Senior Validation Engineer

Beschreibung

Senior Validation Engineer

Summary
You will be responsible for writing, performance and reporting on validation activities related to biopharmaceutical Facilities, Utilities, Equipment (FUE) and associated systems (e.g. automation). As the Senior Validation Engineer you be responsible for planning, coordinating and driving validation activities from initiation to successful completion. This will make you the primary decision maker for assigned validation responsibilities, including deviation investigations, risk / impact assessment.
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:

• Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required).
• Management and co-ordination of validation activities with internal departments, external contractors and suppliers.
• 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.
• Investigation of deviations / non-conformances to determine [potential] impact on product quality, validation status and associated compliance requirements.
• Primary point of contact for validation related issues arising during validation activities (including protocol execution).
• Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities.

Qualifications

• At least 8 years of experience in a Validation/Quality role in a biopharmaceutical manufacturing environment.
• English fluent
• Proven Leadership Experience
• Large scale project experience

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

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