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Validation Engineer

On Target Recruitment
Posted 4 days ago, valid for 18 days
Location

Sunderland, Tyne and Wear SR4 6ST, England

Contract type

Full Time

In order to submit this application, a Reed account will be created for you. As such, in addition to applying for this job, you will be signed up to all Reed’s services as part of the process. By submitting this application, you agree to Reed’s Terms and Conditions and acknowledge that your personal data will be transferred to Reed and processed by them in accordance with their Privacy Policy.

Sonic Summary

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  • The role of Validation Engineer is with a UK manufacturer of single-use medical devices that has a global reach and an outstanding reputation for service and product quality.
  • The position offers a basic salary of £45,000 along with benefits such as a 5% employer pension, health cash plan, and 23 days of annual leave plus bank holidays.
  • Candidates must hold a degree in mechanical or electrical engineering and have previous experience in medical device or pharmaceutical manufacturing, including validation and quality assurance.
  • The role involves ensuring all site validation needs are met, creating validation master plans, and supporting cross-functional risk management activities.
  • The ideal candidate should possess strong communication skills, be a good team player, and have a good understanding of Quality Management Systems for 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:

Tel no.

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

About On Target

At On Target, we specialise in sales, technical and commercial jobs in the Engineering, Construction, Building Services, Medical & Scientific, and Commercial & Industrial Solutions sectors, enabling our consultants to become experts in their market sector. We place all levels of personnel, up to Director across the UK and internationally.

Apply now in a few quick clicks

In order to submit this application, a Reed account will be created for you. As such, in addition to applying for this job, you will be signed up to all Reed’s services as part of the process. By submitting this application, you agree to Reed’s Terms and Conditions and acknowledge that your personal data will be transferred to Reed and processed by them in accordance with their Privacy Policy.