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Job ID :
51687BR
Location :
United Kingdom - Paisley
:
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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