Validation Engineer

Thermo Fisher Scientific
03 Aug 2017
14 Aug 2017
Contract Type
Full Time
Job Description:

Job Title : Validation engineer Reports To: Manufacturing Engineering manager Position Location: Inchinnan Position Objective: The positions objective is to assist with the definition and implementation of operation validation activities that ensure effective oversight of the verification and validation activities are in compliance with EU/FDA regulatory requirements associated with an aseptic cleanroom process Essential Functions * The role of the validation engineer is to support process validations onsite and act as a subject matter expert in customer and regulatory audits * Support Software , Shipping , Room and Equipment qualifications in line with training and experience * Own and develop validation master validation plan and documentation onsite * Provide technical expertise and knowledge on validation to manufacturing group and beyond. * Drive continuous improvement throughout the site with respect to validation activities * Knowledge of current guidelines and regulatory requirements * Support during internal / external and third party audits * Work closely with Production, Technical , Facilities and Manufacturing Engineering to resolve quality related issues arising from customer complaints/concerns and internal incidents. Experience ?? The good working knowledge of the Cell Culture and Bio production business or similar manufacturing process ?? Experience working within a medical device manufacturing environment or cGMP manufacturing environment. ?? Working knowledge of validation within a GMP manufacturing environment Working Conditions ?? Role could require occasional travel and out of hours working ?? Role will require working in controlled environments e.g Cleanrooms *IND-EMEA

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