Validation Engineer

On Target Recruitment Ltd; Durham, Newcastle upon Tyne, Gateshead, Sunderland; On-site; GBP 45,000 - 52,000; Full time

Job summary

A leading UK manufacturer of single-use medical devices is seeking a Validation Engineer to ensure compliance with validation processes. The ideal candidate will hold an engineering degree and have experience in medical device manufacturing, with responsibilities including creating validation plans and ensuring quality standards are met. This permanent role offers a competitive salary and a range of benefits including pension and health plans.

Benefits

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

Qualifications

• Must hold a mechanical or electrical engineering degree.
• Experience in medical device or pharmaceutical manufacturing required.
• Understanding of Quality Management Systems (EN ISO 13485, 21 CFR 820).

Responsibilities

• Ensure all site validation needs are met.
• Create and amend standard operating procedures.
• Support cross-functional risk management activities.

Skills

Communication

Quality Assurance

Teamwork

Education

Mechanical Engineering Degree

Electrical Engineering Degree

Tools

MS Office

Job description

• Type: Permanent

Validation Engineer

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: [e-mail]

Tel no.

0208 397 4114

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.

• Start: ASAP
• Duration: Full-Time

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