Due to significant growth within our EMEA Manufacturing HQ we are recruiting an experienced Calibration Engineer to be based in our Inchinnan site.
You will support process Validations/Calibrations onsite/offsite and act as a subject matter expert in customer and regulatory audits, assisting with the definition and implementation of operation calibration activities that ensure effective oversight of the verification and that calibration activities are in compliance with EU/FDA regulatory requirements associated with an aseptic cleanroom process.
What you will do:
- Develop current calibration process incorporating process improvements that meet regulatory requirements
- Support equipment and processes associated with Software, Shipping, Room and Equipment qualifications in line with training and experience
- Provide technical expertise and knowledge on calibration to manufacturing group and beyond
- Drive continuous improvement throughout the site with respect to calibration 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
Who we are looking for:
- Working knowledge of calibration within a GMP manufacturing environment
- Experience within a calibration or validation engineering role
- Experience working within a medical device manufacturing environment or cGMP manufacturing environment would be beneficial
- Good working knowledge of the Cell Culture and Bio production business or similar manufacturing process would be helpful not but essential
- Focused on process improvement and comfortable reviewing current ways of working and making suggestions for more effective ways of working
What we offer:
- Free car parking
- On site subsidised gym
- 25 days holiday + bank holidays
- Contributory pension scheme
- Private medical insurance
- A variety of flexible benefits
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