Validation Engineer - Single use medical devices

​​​​The Company: 

• UK manufacturer of single use medical devices 

• Global reach 

• Outstanding reputation for service and product quality 

• Looks after their employees 

 

Benefits of the Validation Engineer 

• £45k basic salary,  

• Death in Service (2 x Salary),  

• Employer Pension @ 5% employer + 5% employee,  

• 23 Days annual leave + bank holidays,  

• Health Shield - Employee Health Cash Plan,  

• Perkbox  

 

The Role of the Validation Engineer 

• Our client is a leading medical devices manufacturer  

• This role is to ensure all site validation needs are met 

• You will be responsible for validating all production, service provision, computer and software-based processes, the result of which cannot be verified by subsequent monitoring or measurement.  

• Validation must demonstrate the ability of these processes to consistently achieve expected results. The role includes re-validation of established processes as well as initial validation of amended or new processes, such as those introduced through new product development activities. 

• Creating Validation Master Plans and associated protocols  

• Create or amend standard operating procedures in accordance with the results of the validation 

• Creating validation and related working forms  

• Supporting site cross-functional technical writing needs  

• Maintenance of Sterilisation Validation for both Gamma and Ethylene Oxide processes.  

• Assist in the implementation of the validation protocols and write the validation reports  

• Support cross-functional risk management activities  

• Support in the optimization of production processes  

• Preparation of plans for maintenance, service, calibration, re-validation and cleaning of test and production equipment  

• Policing and coordinating maintenance, service, calibration, re-validation and cleaning 

• Advise the business on current best practice in validation and keep abreast of changes  

• Contribute to continuous improvement projects 

The Ideal Person for the Validation Engineer 

• Must hold a mechanical engineering or electrical engineering degree 

• Must have previous experience of medical device or pharmaceutical manufacturing 

• Must have practical experience in manufacturing technology and quality assurance 

• Must have understanding of Quality Management Systems for medical  

• Devices (EN ISO 13485, 21 CFR 820) 

• Experience in validation / qualification  

• Experience in Project Work and/or Project Management D  

• Good to very good knowledge of common MS Office  

• Programs 

• Able to adhere to and communicate the company values  

• Must have strong communication skills able to communicate with all levels of organisation 

• A good team player who is able to adapt to working independently or with new or short-term teams 

 

If you think the role of Validation Engineer is for you, apply now! 

 

Consultant: David Gray

Email: davidg@otrsales.co.uk 

Tel no. 0208 397 4114 

Candidates must be eligible to work and live in the UK. 

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