Validation Engineer

Proclinical has teamed up with a market leading biotech known for discovering, inventing, developing and manufacturing medicines that treat serious medical conditions. They are an established company who have a global presence but are growing rapidly due to a healthy pipeline of new medicines.

This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Specialists.

Skills and Requriements:

• Managing, developing and building a team of subject matter experts in the areas of cleaning validation and SIP validation and continuing validation.
• Day to day management of resources, planning and assigning work to Validations Specialists and/or contingent workers to meet goals and deadlines.
• Managing multiple and complex validation programs, providing status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.
• Leading technical and quality investigations.
• Collaborating with functional departments to resolve issues.
• Managing a cross-functional projects with many stakeholders
• Reviewing, editing and approving change controls, SOPs, reports and other documentation
• Comprehension of quality and cGMP principles, Quality Management Systems, and relevant Global regulatory guidelines.
• Experience in performing investigations.
• Experience in application of statistics to quality systems.
• Excellent written, oral, and interpersonal communication skills.
• Excellent time and project management skills with the ability to manage several tasks simultaneously.
• Ability to resolve conflict with tact and diplomacy.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Joseph Emmott on +44 203 8141 316 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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