Job Title: Validation engineer
Reports To: Manufacturing Engineering manager
Position Location: Inchinnan
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
- 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.
· 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
· Role could require occasional travel and out of hours working
· Role will require working in controlled environments e.g Cleanrooms